pimecrolimus (Rx)

Brand and Other Names:Elidel
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream

  • 1%

Atopic Dermatitis

Apply thin layer to affected area q12hr; limit application to affected area; continue as long as symptomes persist

Dosage Forms & Strengths

cream

  • 1%

Atopic Dermatitis

<2 years: Safety and efficacy not established

>2 years: Apply thin layer to affected area q12hr; limit application to affected area; continue as long as symptoms persist

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Adverse Effects

>10%

Burning sensation (2-26%)

Headache (7-25%)

Fever (1-13%)

Nasopharyngitis (8-27%)

Cough (2-16%)

Bronchitis (<11%)

Upper respiratory tract infection (4-19%)

<1%

Basal cell carcinoma of skin

Malignant melanoma

Squamous cell carcinoma

Malignant lymphoma

Septic arthritis

Skin discoloration

Eczema

Flushing

Ocular irritation

Frequency Not Defined

Skin infection

Rash

Application site pain

Paraesthesia

Desquamation

Dryness

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Warnings

Black Box Warnings

Rare cases of malignancy reported (although causal relationship not identified); rare cases of lymphoma and skin malignancies reported

Avoid long-term use and limit application to areas of atopic dermatitis; use short-term and intermitent using the minimum necessary to achieve control of symptoms

Not indicated for use in children <2 years

Contraindications

Hypersensitivity

Age <2 years

Not recommended in Netherton's syndrome, immunocompromised patients

Cautions

Preferably use as second-line agents for short-term and intermittent treatment in unresponsive to, or intolerant of other treatments

Re-evaluate if symptoms persist beyond 6 weeks

Do not use with occlusive dressings; do not apply to areas of active cutaneous viral infection

Potential risk of lymphoma and skin cancer; papilloma/warts, observed with use

Reassess diagnosis of atopic dermatitis if symptoms do not improve within 6 weeks of treatment

Safety not established in patients with generalized erythroderma

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: not known whether distributed in breast milk; may cause unwanted effects in nursing babies

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Calcineurin inhibitor; inhibits T-cell activation; also shown to inhibit release of inflammatory mediators from mast cells

Pharmacokinetics

Absorption: Poor

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Elidel topical
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1 % cream
Elidel topical
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1 % cream
Elidel topical
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1 % cream
pimecrolimus topical
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1 % cream
pimecrolimus topical
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1 % cream
pimecrolimus topical
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1 % cream
pimecrolimus topical
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1 % cream

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
pimecrolimus topical

PIMECROLIMUS - TOPICAL

(pim-eck-row-LEE-muss)

COMMON BRAND NAME(S): Elidel

WARNING: Patients have benefited from use of pimecrolimus when it is used correctly. Long-term safety for this drug is not known at this time. There have been rare reports of cancers (e.g., skin cancer, lymphoma) in patients using pimecrolimus. It is not known whether pimecrolimus caused these cancers when used on the skin. Further studies to determine the long-term safety of this product are ongoing. In the unlikely event that unusual lumps, swollen glands, or growths (especially on the skin) occur, contact your doctor right away.The FDA recommends the following: This drug should be used only if other drugs have failed or if other medications are not considered appropriate by your doctor. Pimecrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between. Use the smallest amount that will treat your condition properly, and apply only on the affected skin. Also, this medication should not be used by children younger than 2 years. As with all medications, discuss the risks, benefits, and proper use of this medication with your doctor.

USES: Pimecrolimus is used to treat certain skin conditions such as eczema (atopic dermatitis) in people who should not use or have not responded to other eczema medications (e.g., topical steroids). Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by changing the skin's defense (immune) system, thereby decreasing the allergic reaction that causes eczema. Pimecrolimus belongs to a class of drugs known as topical calcineurin inhibitors (TCIs).This medication is not recommended if you have a history of a certain rare genetic disorder (Netherton's syndrome). Also, this medication should not be used by anyone who has a weakened immune system (e.g., following an organ transplant).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using pimecrolimus and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Wash your hands with soap and water before using this medication. Apply a thin layer to the affected areas of skin, usually twice daily or as directed by your doctor. Rub the medication into the skin gently and completely. Wash your hands after using this product unless your hands are being treated. If your doctor recommends a moisturizer, apply it after this medication.Pimecrolimus is for use on the skin only. Avoid getting this medication in your eyes or on the inside of your nose or mouth. Do not apply this medication to open wounds or infected areas. Do not cover the treated area with plastic or waterproof bandages unless directed to do so by your doctor. Do not bathe, shower or swim right after applying this medication.Use this medication exactly as directed. Your doctor may instruct you to stop using it once your eczema has cleared up and to start using it again if signs or symptoms reappear. Consult your doctor for details.Inform your doctor if your condition does not improve after 6 weeks of using this medication or if your condition worsens at any time.

SIDE EFFECTS: Mild burning or irritation at the application site may occur during the first few days of treatment. Headache may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if the following unlikely but serious side effects occur: signs of infection (e.g., fever, persistent sore throat).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using pimecrolimus, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections (e.g., mononucleosis), use of light therapy (e.g., UVA or UVB), skin infections (e.g., herpes, chickenpox, shingles, warts), immune system problems.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (such as your doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: topical steroids, other ointments/lotions/creams.This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medication may be harmful if swallowed.

NOTES: Do not share this medication with others. This drug should be used as directed for treating your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.Keep all medical appointments while you are using this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze.Make sure the cap on the tube is tightly closed. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.