Arcalyst


Generic Name: rilonacept (Subcutaneous route)

ril-ON-a-sept

Commonly used brand name(s)

In the U.S.

Arcalyst

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interleukin-1 Inhibitor

Uses For Arcalyst

Rilonacept is used to treat cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). Rilonacept can help lessen the signs and symptoms of CAPS, such as rash, joint pain, fever, and tiredness .

This medicine is available only with your doctor's prescription .

Before Using Arcalyst

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rilonacept in children below 12 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rilonacept in the elderly. However, specific side effects may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of rilonacept .

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adalimumab Adenovirus Vaccine Type 4, Live Adenovirus Vaccine Type 7, Live Anakinra Bacillus of Calmette and Guerin Vaccine, Live Etanercept Infliximab Influenza Virus Vaccine, Live Measles Virus Vaccine, Live Mumps Virus Vaccine, Live Poliovirus Vaccine, Live Rotavirus Vaccine, Live Rubella Virus Vaccine, Live Smallpox Vaccine Typhoid Vaccine Varicella Virus Vaccine Yellow Fever Vaccine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Diabetes or Immune system problems—Patients with these conditions will have an increased risk of infection . Serious infections (e.g., HIV, hepatitis B or C, tuberculosis)—Rilonacept may decrease the body's ability to fight infection . Proper Use of Arcalyst

This medicine is given as a shot under your skin. Rilonacept may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected .

This medicine comes with a patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions .

Use a new needle and syringe each time you inject your medicine .

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are bruised, red, tender, or hard .

This powder medicine must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Do not use if it is cloudy or has specks floating in it .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form (vial): For cryopyrin-associated periodic syndromes: Adults—At first, 320 milligrams (mg) given as two, 2-milliliter (mL) doses of 160 mg injected under the skin on the same day at two different sites. Your dose will be adjusted to 160 mg once a week, given as a single, 2 mL injection. Children and teenagers 12 to 17 years of age—At first, 4.4 milligrams (mg) per kilogram (kg) of body weight up to 320 mg given as one or two, 2-milliliter (mL) doses injected under the skin. Your dose will be adjusted to 2.2 mg per kg of body weight up to 160 mg once a week, given as a single, 2 mL injection. Children below 12 years of age—Use and dose must be determined by your doctor . Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Once the powder medicine has been mixed with the liquid, this mixture may be stored at room temperature, away from direct light. You must use this mixture within 3 hours. Throw away any leftover mixture .

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets .

Precautions While Using Arcalyst

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects (e.g., increased amount of cholesterol or fats in the blood) .

Your body's ability to fight infection may be reduced while you are being treated with rilonacept. It is very important that you call your doctor at the first signs of any infection (such as fever or chills; cough or hoarseness; lower back or side pain; or painful or difficult urination) .

While you are being treated with rilonacept, do not have any immunizations (vaccinations) without your doctor's approval. Rilonacept may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. Tell your doctor about any vaccinations you have received in the past. Ask your doctor whether you should receive any vaccinations, including pneumonia and flu shots, before receiving rilonacept .

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test .

Using this medicine may increase your risk of certain types of cancer. Talk with your doctor about this risk .

Rilonacept may cause a serious allergic reaction. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection .

Do not take adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), or infliximab (Remicade®) while you are being treated with this medicine, unless your doctor says it is okay .

Arcalyst Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site body aches or pain chills cough difficulty in breathing ear congestion fever headache loss of voice nasal congestion runny nose sneezing sore throat unusual tiredness or weakness Incidence not known Bloody or black, tarry stools constipation cough producing mucus lower back or side pain pain or tenderness around eyes and cheekbones painful or difficult urination severe stomach pain shortness of breath or troubled breathing tenderness tightness of chest or wheezing vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings Less common Stomach discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Arcalyst side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Arcalyst resources Arcalyst Side Effects (in more detail) Arcalyst Use in Pregnancy & Breastfeeding Arcalyst Drug Interactions Arcalyst Support Group 1 Review for Arcalyst - Add your own review/rating Arcalyst Prescribing Information (FDA) Arcalyst Consumer Overview Arcalyst Monograph (AHFS DI) Arcalyst MedFacts Consumer Leaflet (Wolters Kluwer) Rilonacept Professional Patient Advice (Wolters Kluwer) Compare Arcalyst with other medications Cryopyrin-Associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle Wells Syndrome


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Pinxav


Generic Name: zinc oxide topical (ZINK OX ide)
Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Pinxav (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Pinxav (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Pinxav (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Pinxav (zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting. What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Pinxav (zinc oxide topical)? Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury. Pinxav (zinc oxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pinxav (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Pinxav resources Pinxav Side Effects (in more detail) Pinxav Use in Pregnancy & Breastfeeding Pinxav Support Group 0 Reviews for Pinxav - Add your own review/rating Arcalyst Monograph (AHFS DI) Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Pinxav with other medications Anal Itching Dermatologic Lesion Where can I get more information? Your pharmacist can provide more information about zinc oxide topical.

See also: Pinxav side effects (in more detail)


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Calmol-4 Suppository


Generic Name: zinc oxide topical (ZINK OX ide)
Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Calmol-4 Suppository (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Calmol-4 Suppository (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Calmol-4 Suppository (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Calmol-4 Suppository (zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting. What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Calmol-4 Suppository (zinc oxide topical)? Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury. Calmol-4 Suppository (zinc oxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Calmol-4 Suppository (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Calmol-4 Suppository resources Calmol-4 Suppository Side Effects (in more detail) Calmol-4 Suppository Use in Pregnancy & Breastfeeding Calmol-4 Suppository Support Group 0 Reviews for Calmol-4 - Add your own review/rating Arcalyst Monograph (AHFS DI) Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Calmol-4 Suppository with other medications Anal Itching Dermatologic Lesion Where can I get more information? Your pharmacist can provide more information about zinc oxide topical.

See also: Calmol-4 side effects (in more detail)


More




Medi-Paste


Generic Name: zinc oxide topical (ZINK OX ide)
Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Medi-Paste (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Medi-Paste (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Medi-Paste (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Medi-Paste (zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting. What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Medi-Paste (zinc oxide topical)? Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury. Medi-Paste (zinc oxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Medi-Paste (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Medi-Paste resources Medi-Paste Side Effects (in more detail) Medi-Paste Use in Pregnancy & Breastfeeding Medi-Paste Support Group 0 Reviews for Medi-Paste - Add your own review/rating Arcalyst Monograph (AHFS DI) Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Medi-Paste with other medications Anal Itching Dermatologic Lesion Where can I get more information? Your pharmacist can provide more information about zinc oxide topical.

See also: Medi-Paste side effects (in more detail)


More




Critic-Aid Skin Paste


Generic Name: zinc oxide topical (ZINK OX ide)
Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Critic-Aid Skin Paste (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Critic-Aid Skin Paste (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Critic-Aid Skin Paste (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Critic-Aid Skin Paste (zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting. What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Critic-Aid Skin Paste (zinc oxide topical)? Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury. Critic-Aid Skin Paste (zinc oxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Critic-Aid Skin Paste (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Critic-Aid Skin Paste resources Critic-Aid Skin Paste Side Effects (in more detail) Critic-Aid Skin Paste Use in Pregnancy & Breastfeeding Critic-Aid Skin Paste Support Group 0 Reviews for Critic-Aid Skin - Add your own review/rating Arcalyst Monograph (AHFS DI) Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Critic-Aid Skin Paste with other medications Anal Itching Dermatologic Lesion Where can I get more information? Your pharmacist can provide more information about zinc oxide topical.

See also: Critic-Aid Skin side effects (in more detail)


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Sportz Block Medium


Generic Name: zinc oxide topical (ZINK OX ide)
Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Sportz Block Medium (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Sportz Block Medium (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Sportz Block Medium (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Sportz Block Medium (zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting. What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Sportz Block Medium (zinc oxide topical)? Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury. Sportz Block Medium (zinc oxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sportz Block Medium (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sportz Block Medium resources Sportz Block Medium Side Effects (in more detail) Sportz Block Medium Use in Pregnancy & Breastfeeding Sportz Block Medium Support Group 0 Reviews for Sportz Block Medium - Add your own review/rating Arcalyst Monograph (AHFS DI) Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Sportz Block Medium with other medications Anal Itching Dermatologic Lesion Where can I get more information? Your pharmacist can provide more information about zinc oxide topical.

See also: Sportz Block Medium side effects (in more detail)


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Sportz Block Light


Generic Name: zinc oxide topical (ZINK OX ide)
Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Sportz Block Light (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Sportz Block Light (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Sportz Block Light (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Sportz Block Light (zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting. What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Sportz Block Light (zinc oxide topical)? Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury. Sportz Block Light (zinc oxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sportz Block Light (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sportz Block Light resources Sportz Block Light Side Effects (in more detail) Sportz Block Light Use in Pregnancy & Breastfeeding Sportz Block Light Support Group 0 Reviews for Sportz Block Light - Add your own review/rating Arcalyst Monograph (AHFS DI) Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Sportz Block Light with other medications Anal Itching Dermatologic Lesion Where can I get more information? Your pharmacist can provide more information about zinc oxide topical.

See also: Sportz Block Light side effects (in more detail)


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Ilaris



Dosage Form: injection, powder, lyophilized, for solution
FULL PRESCRIBING INFORMATION Indications and Usage for Ilaris

Ilaris (canakinumab) is an interleukin-1? blocker indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older including:

Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS) Ilaris Dosage and Administration General Dosing Information

INJECTION FOR SUBCUTANEOUS USE ONLY.

Recommended Dose

The recommended dose of Ilaris is 150 mg for CAPS patients with body weight greater than 40 kg. For CAPS patients with body weight between 15 kg and 40 kg, the recommended dose is 2 mg/kg. For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg. 

Ilaris is administered every eight weeks as a single dose via subcutaneous injection.

Preparation for Administration

Using aseptic technique, reconstitute each vial of Ilaris by slowly injecting 1 mL of preservative-free Sterile Water for Injection with a 1 mL syringe and an 18 G x 2” needle. Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for 5 minutes. Then gently turn the vial upside down and back again ten times. Avoid touching the rubber stopper with your fingers. Allow to stand for about 15 minutes at room temperature to obtain a clear solution. Do not shake. Do not use if particulate matter is present in the solution. Tap the side of the vial to remove any residual liquid from the stopper. The reconstituted solution should be essentially free from particulates, and clear to opalescent. The solution should be colorless or may have a slight brownish-yellow tint. If the solution has a distinctly brown discoloration it should not be used. If not used within 60 minutes of reconstitution, the solution should be stored in the refrigerator at 2 to 8° C (36 to 46° F) and used within 4 hours. Slight foaming of the product upon reconstitution is not unusual.

Using a sterile syringe and needle carefully withdraw the required volume depending on the dose to be administered (0.2 mL to 1 mL) and subcutaneously inject using a 27 G x 0.5” needle.

Injection into scar tissue should be avoided as this may result in insufficient exposure to Ilaris.

Ilaris 180-mg powder for solution for injection is supplied in a single-use vial. Any unused product or waste material should be disposed of in accordance with local requirements.

Dosage Forms and Strengths

Ilaris is supplied as a 180 mg white lyophilized powder for solution for subcutaneous injection. Reconstitution with 1 mL of preservative-free Sterile Water for Injection is required prior to subcutaneous administration of the drug, resulting in a total volume of 1.2 mL reconstituted solution. The reconstituted Ilaris is a clear to slightly opalescent, colorless to a slight brownish yellow tint, essentially free from particulates, 150 mg/mL solution.

Contraindications

Confirmed hypersensitivity to the active substance or to any of the excipients [see Warnings and Precautions (5.3) and Adverse Reactions (6.3)].

Warnings and Precautions Serious Infections

Ilaris may be associated with an increased risk of serious infections. Physicians should exercise caution when administering Ilaris to patients with infections, a history of recurring infections or underlying conditions which may predispose them to infections. Ilaris should not be administered to patients during an active infection requiring medical intervention. Administration of Ilaris should be discontinued if a patient develops a serious infection.

Infections, predominantly of the upper respiratory tract, in some instances serious, have been reported with Ilaris. Generally, the observed infections responded to standard therapy. Isolated cases of unusual or opportunistic infections were reported during Ilaris treatment. In clinical trials, Ilaris has not been administered concomitantly with tumor necrosis factor (TNF) inhibitors. An increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors. Co-administration of Ilaris with TNF inhibitors is not recommended because this may increase the risk of serious infections [see Drug Interactions (7.1)].

Drugs that affect the immune system by blocking TNF have been associated with an increased risk of new tuberculosis and reactivation of latent tuberculosis (TB). It is possible that use of IL-1 inhibitors such as Ilaris increases the risk of reactivation of tuberculosis or of opportunistic infections.

Prior to initiating immunomodulatory therapies, including Ilaris, patients should be evaluated for active and latent tuberculosis infection. Appropriate screening tests should be performed in all patients. Ilaris has not been studied in patients with a positive tuberculosis screen, and the safety of Ilaris in individuals with latent tuberculosis infection is unknown. Patients testing positive in tuberculosis screening should be treated according to standard medical practice prior to therapy with Ilaris. All patients should be instructed to seek medical advice if signs, symptoms, or high risk exposure suggestive of tuberculosis (e.g. persistent cough, weight loss, subfebrile temperature) appear during or after Ilaris therapy.

Healthcare providers should follow current CDC guidelines both to evaluate for and to treat possible latent tuberculosis infections before initiating therapy with Ilaris.

Immunosuppression

The impact of treatment with anti-interleukin-1 (IL-1) therapy on the development of malignancies is not known. However, treatment with immunosuppressants, including Ilaris, may result in an increase in the risk of malignancies.

Hypersensitivity

Hypersensitivity reactions have been reported with Ilaris therapy. No anaphylactic reactions have been reported. It should be recognized that symptoms of the underlying disease being treated may be similar to symptoms of hypersensitivity. Ilaris should not be administered to any patients with known clinical hypersensitivity to Ilaris [see Contraindications (4) and Adverse Reactions (6.3)].

Immunizations

Live vaccines should not be given concurrently with Ilaris [see Drug Interactions (7.2)]. Since no data are available on either the efficacy or on the risks of secondary transmission of infection by live vaccines in patients receiving Ilaris, live vaccines should not be given concurrently with Ilaris. In addition, because Ilaris may interfere with normal immune response to new antigens, vaccinations may not be effective in patients receiving Ilaris. No data are available on the effectiveness of vaccinations with inactivated (killed) antigens in patients receiving Ilaris. [see Drug Interactions (7.2)].

Because IL-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with Ilaris, adult and pediatric patients receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine. (See current recommended immunization schedules at the website of the Centers for Disease Control, http://www.cdc.gov/vaccines/recs/schedules/).

Adverse Reactions

The data described herein reflect exposure to Ilaris in 104 adult and pediatric CAPS patients, (including 20 FCAS, 72 MWS, 10 MWS/NOMID (Neonatal Onset Multisystem Inflammatory Disorder) overlap, 1 non-FCAS non-MWS, and 1 mis-diagnosed in placebo-controlled (35 patients) and uncontrolled trials. Sixty-two patients were exposed to Ilaris for at least 6 months, 56 for at least 1 year and 4 for at least 3 years. A total of 9 serious adverse reactions were reported for CAPS patients. Among these were vertigo (2 patients), infections (3 patients), including intra-abdominal abscess following appendectomy (1 patient). The most commonly reported adverse reactions associated with Ilaris treatment in the CAPS patients were nasopharyngitis, diarrhea, influenza, headache, and nausea. No impact on the type or frequency of adverse drug reactions was seen with longer-term treatment. One patient discontinued treatment due to potential infection.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trial Experience 

Approximately 833 subjects have been treated with Ilaris in blinded and open-label clinical trials in CAPS and other diseases, and healthy volunteers. A total of 15 patients reported serious adverse reactions during the clinical program.

Study 1 investigated the safety of Ilaris in an 8-week, open-label period (Part 1), followed by a 24-week, randomized withdrawal period (Part 2), followed by a 16-week, open-label period (Part 3). All patients were treated with Ilaris 150 mg subcutaneously or 2 mg/kg if body weight was greater than or equal to 15 kg and less than or equal to 40 kg (see Table 1).

Since all CAPS patients received Ilaris in Part 1, there are no controlled data on adverse events (AEs). Data in Table 1 are for all AEs for all CAPS patients receiving canakinumab. In study 1, no pattern was observed for any type or frequency of adverse events throughout the three study periods.

Table 1 Number (%) of Patients with AEs by Preferred Terms, in > 10% of Patients in Parts 1 to 3 of the Phase 3 Trial for CAPS Patients  
Preferred Term Ilaris
N=35
n (%) n % of Patients with Adverse Events 35 (100)     Nasopharyngitis 12 (34)     Diarrhea 7 (20)     Influenza 6 (17)     Rhinitis 6 (17)     Nausea 5 (14)     Headache 5 (14)     Bronchitis 4 (11)     Gastroenteritis 4 (11)     Pharyngitis 4 (11)     Weight increased 4 (11) Musculoskeletal pain 4(11) Vertigo 4(11) Vertigo

Vertigo has been reported in 9 to 14% of patients in CAPS studies, exclusively in MWS patients, and reported as a serious adverse event in two cases. All events resolved with continued treatment with Ilaris.

Hypersensitivity

Hypersensitivity reactions have been reported with Ilaris therapy. No anaphylactic reactions have been reported. Ilaris should not be administered to any patients with known clinical hypersensitivity to Ilaris [see Contraindications (4) and Warnings and Precautions (5.3)].

Injection Site Reactions

In Study 1, subcutaneous injection site reactions were observed in 9% of patients in Part 1 with mild tolerability reactions; in Part 2, one patient each (7%) had a mild or a moderate tolerability reaction and, in Part 3, one patient had a mild local tolerability reaction. No severe injection-site reactions were reported and none led to discontinuation of treatment.

Immunogenicity

A specific biosensor binding assay was used to detect antibodies directed against canakinumab in patients who received Ilaris. None of the 60 CAPS patients who had received Ilaris tested positive for treatment-emergent binding antibodies at the time points tested. Thirty-one of 60 CAPS patients had a duration of exposure to canakinumab >48 weeks. The data obtained in an assay is highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, underlying disease, and the number of patients tested. For these reasons, comparison of the incidence of antibodies to canakinumab with the incidence of antibodies to other products may be misleading.

Laboratory Findings

Hematology

During clinical trials with Ilaris, mean values decreased for white blood cells, neutrophils and platelets.

Hepatic transaminases

Elevations of transaminases have been observed in patients treated with Ilaris.

Bilirubin

Asymptomatic and mild elevations of serum bilirubin have been observed in patients treated with Ilaris without concomitant elevations of transaminases.

Drug Interactions

Interactions between Ilaris and other medicinal products have not been investigated in formal studies.

TNF-Blocker and IL-1 Blocking Agent 

An increased incidence of serious infections and an increased risk of neutropenia have been associated with administration of another IL-1 blocker in combination with TNF inhibitors in another patient population. Use of Ilaris with TNF inhibitors may also result in similar toxicities and is not recommended because this may increase the risk of serious infections [see Warnings and Precautions (5.1)].

The concomitant administration of Ilaris with other drugs that block IL-1 has not been studied. Based upon the potential for pharmacological interactions between Ilaris and a recombinant IL-1ra, concomitant administration of Ilaris and other agents that block IL-1 or its receptors is not recommended.

Immunization 

No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving Ilaris. Therefore, live vaccines should not be given concurrently with Ilaris. It is recommended that, if possible, pediatric and adult patients should complete all immunizations in accordance with current immunization guidelines prior to initiating Ilaris therapy [see Warnings and Precautions (5.4)].

Cytochrome P450 Substrates 

The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation. Thus it is expected that for a molecule that binds to IL-1, such as canakinumab, the formation of CYP450 enzymes could be normalized. This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin). Upon initiation of canakinumab, in patients being treated with these types of medicinal products, therapeutic monitoring of the effect or drug concentration should be performed and the individual dose of the medicinal product may need to be adjusted as needed.

USE IN SPECIFIC POPULATIONS Pregnancy

Pregnancy Category C

Canakinumab has been shown to produce delays in fetal skeletal development when evaluated in marmoset monkeys using doses 23-fold the maximum recommended human dose (MRHD) and greater (based on a plasma area under the time-concentration curve [AUC] comparison). Doses producing exposures within the clinical exposure range at the MRHD were not evaluated. Similar delays in fetal skeletal development were observed in mice administered a murine analog of canakinumab. There are no adequate and well-controlled studies of Ilaris in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Embryofetal developmental toxicity studies were performed in marmoset monkeys and mice. Pregnant marmoset monkeys were administered canakinumab subcutaneously twice weekly at doses of 15, 50 or 150 mg/kg (representing 23 to 230-fold the human dose based on a plasma AUC comparison at the MRHD) from gestation days 25 to 109 which revealed no evidence of embryotoxicity or fetal malformations. There were increases in the incidence of incomplete ossification of the terminal caudal vertebra and misaligned and/or bipartite vertebra in fetuses at all dose levels when compared to concurrent controls suggestive of delay in skeletal development in the marmoset. Since canakinumab does not cross-react with mouse or rat IL-1, pregnant mice were subcutaneously administered a murine analog of canakinumab at doses of 15, 50, or 150 mg/kg on gestation days 6, 11 and 17. The incidence of incomplete ossification of the parietal and frontal skull bones of fetuses was increased in a dose-dependent manner at all dose levels tested.

Nursing Mothers

It is not known whether canakinumab is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ilaris is administered to a nursing woman.

Pediatric Use 

The CAPS trials with Ilaris included a total of 23 pediatric patients with an age range from 4 years to 17 years (11 adolescents were treated subcutaneously with 150 mg , and 12 children were treated with 2 mg/kg based on body weight greater than or equal to 15 kg and less than or equal to 40 kg ). The majority of patients achieved improvement in clinical symptoms and objective markers of inflammation (e.g., Serum Amyloid A and C-Reactive Protein). Overall, the efficacy and safety of Ilaris in pediatric and adult patients were comparable. Infections of the upper respiratory tract were the most frequently reported infection. The safety and effectiveness of Ilaris in patients under 4 years of age has not been established [see Pharmacokinetics (12.3)].

Geriatric Use

Clinical studies of Ilaris did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Patients with Renal Impairment 

No formal studies have been conducted to examine the pharmacokinetics of Ilaris administered subcutaneously in patients with renal impairment.

Patients with Hepatic Impairment

No formal studies have been conducted to examine the pharmacokinetics of Ilaris administered subcutaneously in patients with hepatic impairment.

Overdosage

No case of overdose has been reported. In the case of overdose, it is recommended that the subject be monitored for any signs and symptoms of adverse reactions or effects, and appropriate symptomatic treatment be instituted immediately.

Ilaris Description

Canakinumab is a recombinant, human anti-human-IL-1? monoclonal antibody that belongs to the IgG1/? isotype subclass. It is expressed in a murine Sp2/0-Ag14 cell line and comprised of two 447- (or 448-) residue heavy chains and two 214-residue light chains, with a molecular mass of 145157 Daltons when deglycosylated. Both heavy chains of canakinumab contain oligosaccharide chains linked to the protein backbone at asparagine 298 (Asn 298).

The biological activity of canakinumab is measured by comparing its inhibition of IL-1?-dependent expression of the reporter gene luciferase to that of a canakinumab internal reference standard, using a stably transfected cell line.

Ilaris is supplied in a sterile, single-use, colorless, 6 mL glass vial with coated stopper and aluminum flip-off cap. Each vial contains 180 mg of canakinumab as a white, preservative-free, lyophilized powder. Reconstitution with 1 mL of preservative-free Sterile Water for Injection is required prior to subcutaneous administration of the drug. The reconstituted canakinumab is a 150 mg/mL solution essentially free of particulates, clear to slightly opalescent, and is colorless or may have a slightly brownish-yellow tint. A volume of up to 1 mL can be withdrawn for delivery of 150 mg/mL canakinumab for subcutaneous administration. Each reconstituted vial contains 180 mg canakinumab, sucrose, L-histidine, L-histidine HCL monohydrate, polysorbate 80 and Sterile Water for Injection. No preservatives are present.

Ilaris - Clinical Pharmacology Mechanism of Action

CAPS refer to rare genetic syndromes generally caused by mutations in the NLRP-3 [nucleotide-binding domain, leucine rich family (NLR), pyrin domain containing 3] gene (also known as Cold-Induced Auto-inflammatory Syndrome-1 [CIAS1]). CAPS disorders are inherited in an autosomal dominant pattern with male and female offspring equally affected. Features common to all disorders include fever, urticaria-like rash, arthralgia, myalgia, fatigue, and conjunctivitis.

The NLRP-3 gene encodes the protein cryopyrin, an important component of the inflammasome. Cryopyrin regulates the protease caspase-1 and controls the activation of interleukin-1 beta (IL-1?). Mutations in NLRP-3 result in an overactive inflammasome resulting in excessive release of activated IL-1? that drives inflammation.

Canakinumab is a human monoclonal anti-human IL-1? antibody of the IgG1/? isotype. Canakinumab binds to human IL-1? and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1? or IL-1 receptor antagonist (IL-1ra).

Pharmacodynamics

C-reactive protein and Serum Amyloid A (SAA) are indicators of inflammatory disease activity that are elevated in patients with CAPS. Elevated SAA has been associated with the development of systemic amyloidosis in patients with CAPS. Following Ilaris treatment, CRP and SAA levels normalize within 8 days.

Pharmacokinetics

Absorption

The peak serum canakinumab concentration (Cmax) of 16 ± 3.5 ?g/mL occurred approximately 7 days after subcutaneous administration of a single, 150-mg dose subcutaneously to adult CAPS patients. The mean terminal half-life was 26 days. The absolute bioavailability of subcutaneous canakinumab was estimated to be 70%. Exposure parameters (such as AUC and Cmax) increased in proportion to dose over the dose range of 0.30 to 10 mg/kg given as intravenous infusion or from 150 to 300 mg as subcutaneous injection.

Distribution

Canakinumab binds to serum IL-1?. Canakinumab volume of distribution (Vss) varied according to body weight and was estimated to be 6.01 liters in a typical CAPS patient weighing 70 kg. The expected accumulation ratio was 1.3-fold following 6 months of subcutaneous dosing of 150 mg Ilaris every 8 weeks.

Elimination

Clearance (CL) of canakinumab varied according to body weight and was estimated to be 0.174 L/day in a typical CAPS patient weighing 70 kg. There was no indication of accelerated clearance or time-dependent change in the pharmacokinetic properties of canakinumab following repeated administration. No gender- or age-related pharmacokinetic differences were observed after correction for body weight.

Pediatrics

Peak concentrations of canakinumab occurred between 2 to 7 days following single subcutaneous administration of Ilaris 150 mg or 2 mg/kg in pediatric patients. The terminal half-life ranged from 22.9 to 25.7 days, similar to the pharmacokinetic properties observed in adults.

Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of canakinumab.

The mutagenic potential of canakinumab was not evaluated.

As canakinumab does not cross-react with rodent IL-1?, male and female fertility was evaluated in a mouse model using a murine analog of canakinumab. Male mice were treated weekly beginning 4 weeks prior to mating and continuing through 3 weeks after mating. Female mice were treated weekly for 2 weeks prior to mating through gestation day 3 or 4. The murine analog of canakinumab did not alter either male or female fertility parameters at subcutaneous doses up to 150 mg/kg.

Clinical Studies

The efficacy and safety of Ilaris for the treatment of CAPS was demonstrated in Study 1, a 3-part trial in patients 9 to 74 years of age with the MWS phenotype of CAPS. Throughout the trial, patients weighing more than 40 kg received Ilaris 150 mg and patients weighing 15 to 40 kg received 2 mg/kg. Part 1 was an 8-week open-label, single-dose period where all patients received Ilaris. Patients who achieved a complete clinical response and did not relapse by Week 8 were randomized into Part 2, a 24-week randomized, double-blind, placebo-controlled withdrawal period. Patients who completed Part 2 or experienced a disease flare entered Part 3, a 16-week open-label active treatment phase. A complete response was defined as ratings of minimal or better for physician’s assessment of disease activity (PHY) and assessment of skin disease (SKD) and had serum levels of C-Reactive Protein (CRP) and Serum Amyloid A (SAA) less than 10 mg/L. A disease flare was defined as a CRP and/or SAA values greater than 30 mg/L and either a score of mild or worse for PHY or a score of minimal or worse for PHY and SKD.

In Part 1, a complete clinical response was observed in 71% of patients one week following initiation of treatment and in 97% of patients by Week 8 (see Figure 1 and Table 2). In the randomized withdrawal period, a total of 81% of the patients randomized to placebo flared as compared to none (0%) of the patients randomized to Ilaris. The 95% confidence interval for treatment difference in the proportion of flares was 53% to 96%. At the end of Part 2, all 15 patients treated with Ilaris had absent or minimal disease activity and skin disease (see Table 2).

In a second trial, patients 4 to 74 years of age with both MWS and FCAS phenotypes of CAPS were treated in an open-label manner. Treatment with Ilaris resulted in clinically significant improvement of signs and symptoms and in normalization of high CRP and SAA in a majority of patients within 1 week.

Table 2 Physician’s Global Assessment of Auto-Inflammatory Disease Activity and Assessment of Skin Disease: Frequency Table and Treatment Comparison in Part 2 (Using LOCF, ITT Population) Ilaris
N= 15 Placebo
N= 16
Baseline Start of Part 2 (Week 8) End of Part 2 Start of Part 2 (Week 8) End of Part 2 Physician's Global Assessment of Auto-Inflammatory Disease Activity - n (%) Absent 0/31 (0) 9/15 (60) 8/15 (53) 8/16 (50) 0/16 (0) Minimal 1/31 (3) 4/15 (27) 7/15 (47) 8/16 (50) 4/16 (25) Mild 7/31 (23) 2/15 (13) 0/15 (0) 0/16 (0) 8/16 (50) Moderate 19/31 (61) 0/15 (0) 0/15 (0) 0/16 (0) 4/16 (25) Severe 4/31 (13) 0/15 (0) 0/15 (0) 0/16 (0) 0/16 (0) Assessment of Skin Disease – n (%) Absent 3/31 (10) 13/15 (87) 14/15 (93) 13/16 (81) 5/16 (31) Minimal 6/31 (19) 2/15 (13) 1/15 (7) 3/16 (19) 3/16 (19) Mild 9/31 (29) 0/15 (0) 0/15 (0) 0/16 (0) 5/16 (31) Moderate 12/31 (39) 0/15 (0) 0/15 (0) 0/16 (0) 3/16 (19) Severe 1/32 (3) 0/15 (0) 0/15 (0) 0/16 (0) 0/16 (0)

Markers of inflammation CRP and SAA normalized within 8 days of treatment in the majority of patients. Normal mean CRP (Figure 1) and SAA values were sustained throughout study 1 in patients continuously treated with canakinumab. After withdrawal of canakinumab in Part 2 CRP (figure 1) and SAA values again returned to abnormal values and subsequently normalized after reintroduction of canakinumab in Part 3. The pattern of normalization of CRP and SAA was similar.

Figure 1. Mean C-Reactive Protein Levels at the End of Parts 1, 2 and 3 of Study 1

How Supplied/Storage and Handling

Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61 

Each 6 mL single-use vial of Ilaris contains a sterile, preservative free, white lyophilized powder containing 180 mg of canakinumab. Each vial is to be reconstituted with 1 mL of preservative-free Sterile Water for Injection in a 150 mg/mL solution.

Special Precautions for Storage

The unopened vial must be stored refrigerated at 2 to 8° C (36 to 46° F). Do not freeze. Store in the original carton to protect from light. Do not use beyond the date stamped on the label. After reconstitution, Ilaris should be kept from light, and can be kept at room temperature if used within 60 minutes of reconstitution. Otherwise, it should be refrigerated at 2 to 8? C (36 to 46? F) and used within 4 hours of reconstitution. Ilaris does not contain preservatives. Unused portions of Ilaris should be discarded.

Keep this and all drugs out of the reach of children.

Patient Counseling Information

See FDA-approved Patient Labeling.

Patients should be provided the opportunity to read the Patient Information for Ilaris prior to the first treatment and any questions resulting from the patient’s reading of the guide should be discussed.

Drug Administration 

Healthcare providers should perform administration of Ilaris by the subcutaneous injection route.  

Infections

Patients should be cautioned that Ilaris use has been associated with serious infections. Patients should be counseled to contact their healthcare professional immediately if they develop an infection after starting Ilaris. Treatment with Ilaris should be discontinued if a patient develops a serious infection. Patients should be counseled not to take any IL-1 blocking drug, including Ilaris, if they are also taking a drug that blocks TNF such as etanercept, infliximab, or adalimumab. Use of Ilaris with other IL-1 blocking agents, such as rilonacept and anakinra is not recommended. Patients should be cautioned not to receive Ilaris if they have a chronic or active infection, including HIV, Hepatitis B or Hepatitis C.

Vaccinations

Prior to initiation of therapy with Ilaris, physicians should review with adult and pediatric patients their vaccination history relative to current medical guidelines for vaccine use, including taking into account the potential of increased risk of infection during treatment with Ilaris.

Injection-site Reactions

Physicians should explain to patients that a very small number of patients in the clinical trials experienced a reaction at the subcutaneous injection site. Injection-site reactions may include pain, erythema, swelling, pruritus, bruising, mass, inflammation, dermatitis, edema, urticaria, vesicles, warmth, and hemorrhage. Healthcare providers should be cautioned to avoid injecting into an area that is already swollen or red. Any persistent reaction should be brought to the attention of the prescribing physician.

Hypersensitivity

Patients should be counseled to contact their healthcare provider immediately if they develop signs of allergic reaction such as difficulty breathing or swallowing, nausea, dizziness, skin rash, itching, hives, palpitations or low blood pressure.

INFORMATION FOR PATIENTS

See patient information leaflet.

Patient Information

Ilaris® (i-LAHR-us)

(canakinumab)

Read the Patient Information that comes with Ilaris before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What is Ilaris?  Ilaris is a prescription medicine injected just below the skin (subcutaneous) used in adults and children 4 years and older to treat auto-inflammatory diseases known as Cryopyrin-Associated Periodic Syndromes (CAPS), including:

Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS),

It is not known if Ilaris is safe or effective in children under 4 years of age.

Who should not take Ilaris?

Do not take Ilaris if you:

are allergic to canakinumab or any of the ingredients in Ilaris. See the end of this Patient Information leaflet for a complete list of the ingredients in Ilaris.

What should I tell my healthcare provider before taking Ilaris?

Before you take Ilaris, tell your healthcare provider if you:

think you have an infection
are being treated for an infection
have signs of an infection, such as fever, cough, or flu-like symptoms
have a history of infections that keep coming back
have or have had HIV, Hepatitis B, or Hepatitis C
have an immune system problem. People with these conditions have a higher chance for infections.
have tuberculosis (TB), or if you have been in close contact with someone who has or has had tuberculosis
are scheduled to receive any immunizations (vaccines). You should not get ‘live vaccines’ if you take Ilaris.
are pregnant or planning to become pregnant. It is not known if Ilaris will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Ilaris.
are breastfeeding or planning to breastfeed. It is not known if Ilaris passes into your breast milk. You and your healthcare provider should decide if you will take Ilaris or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take:

Medicines that affect your immune system
IL-1 blocking agents such as Kineret® (anakinra), Arcalyst® (rilonacept)
Tumor Necrosis Factor (TNF) inhibitors such as Enbrel® (etanercept)
Humira® (adalimumab), or Remicade® (infliximab)
Medicines that can affect enzyme metabolism. Ask your healthcare provider if you are not sure.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How will I receive Ilaris?

Do not receive Ilaris if you have an infection.
Ilaris is given by your healthcare provider every 8 weeks
Your healthcare provider may change your dose if needed.

What are the possible side effects of Ilaris?

Ilaris can cause serious side effects including:

serious infections. Symptoms of an infection may include: a fever lasting longer than 3 days a cough that does not go away redness in one part of your body warm feeling or swelling of your skin decrease your body’s ability to fight infections (immunosuppression)

Other serious side effects may occur while you are taking and after you finish taking Ilaris including allergic reactions. Symptoms of an allergic reaction may include:

rash (hives) swollen face problems breathing or swallowing

Call your healthcare provider right away or get emergency medical help if you have any of the signs of an infection or allergic reaction.

The most common side effects include:

cold symptoms
diarrhea
flu (influenza)
runny nose
nausea
headache
injection site reaction (such as redness, swelling, warmth, itching)
feeling like you are spinning (vertigo)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ilaris. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Ilaris 

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets. Do not use Ilaris for a condition for which it was not prescribed.

This leaflet summarizes the most important information about Ilaris. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Ilaris that was written for health professionals. For more information about Ilaris, call 1-877-452-7471 or visit www.Ilaris.com.

What are the ingredients in Ilaris?

Active ingredients: canakinumab

Inactive ingredients: sucrose, L-histidine, L-histidine HCl monohydrate, polysorbate 80, preservative-free Sterile Water for Injection.

What is CAPS Disease?

In patients with CAPS, the body produces excessive amounts of a chemical messenger called interleukin-1 beta (IL-1?). This may lead to symptoms such as fever, headache, fatigue, skin rash, painful joints and muscles. In some patients, more severe outcomes such as hearing impairment are observed.

Kineret®, Arcalyst®, Enbrel®, Humira®, Remicade® are trademarks of Amgen, Regeneron, Immunex Corporation, Abbott Laboratories, Centocor Ortho Biotech Inc., respectively.

Manufactured By:

Novartis Pharma Stein AG

Stein, Switzerland

Distributed By:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

© Novartis

T2012-39/T2011-137

January 2012/November 2011

PRINCIPAL DISPLAY PANEL

Package Label – 180 mg sterile powder for reconstitution/vial*

Rx Only             NDC 0078-0582-61

Ilaris® (canakinumab)

For Injection

For Subcutaneous Use

Single use vial             Sterile, Lyophilized

*Reconstitute with 1 mL of water for injection to obtain a concentration

of 150 mg/mL canakinumab, 92.38 mg/mL sucrose, and 0.60 mg/mL

polysorbate 80. L-histidine and L-histidine hydrochloride monohydrate

are used to adjust and buffer pH.


Ilaris 
canakinumab  injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0078-0582 Route of Administration SUBCUTANEOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANAKINUMAB (CANAKINUMAB) CANAKINUMAB 150 mg  in 1 mL Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 0.6 mg  in 1 mL SUCROSE 92.38 mg  in 1 mL WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0078-0582-61 1 VIAL In 1 CARTON contains a VIAL, SINGLE-USE 1 1 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (0078-0582-61)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125319 06/18/2009
Labeler - Novartis Pharmaceuticals Corporation (002147023) Revised: 01/2012Novartis Pharmaceuticals Corporation


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