Elidel

— THERAPEUTIC CATEGORIES —
  • Atopic dermatitis
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Elidel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Pimecrolimus 1%; crm.

    Pharmacological Class

    Immunomodulator.

    How Supplied

    Crm—30g, 60g, 100g

    How Supplied

    Elidel Cream, 1% is a whitish cream available in tubes of 30 grams, 60 grams, and 100 grams.

    Storage

    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

    Manufacturer

    Bausch Health Companies Inc.

    Mechanism of Action

    The mechanism of action of pimecrolimus in atopic dermatitis is not known. It has been demonstrated that pimecrolimus binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T-cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits Interleukin-2 and interferon gamma (Th1-type) and Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T-cells. In addition, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/IgE.

    Elidel Indications

    Indications

    Second-line therapy: for short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients when other topical therapies are inadvisable or ineffective.

    Elidel Dosage and Administration

    Adults and Children

    <2yrs: not recommended. ≥2yrs: apply to affected area(s) twice daily. Do not occlude.

    Elidel Contraindications

    Not Applicable

    Elidel Boxed Warnings

    Boxed Warning

    Long term safety of topical calcineurin inhibitors has not been established.

    Boxed Warning

    Long-Term Safety Of Topical Calcineurin Inhibitors Has Not Been Established

    • Although a causal relationship has not been established, rare cases of malignancy (eg, skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Elidel Cream, 1%.

    • Avoid continuous long-term use of topical calcineurin inhibitors in any age group and only apply to areas of involvement with atopic dermatitis.

    • Not indicated for use in children less than 2 years of age.

    Elidel Warnings/Precautions

    Warnings/Precautions

    Clear infections at treatment site before starting. Netherton's syndrome, generalized erythroderma, malignant or pre-malignant skin conditions: not recommended. Varicella zoster. Eczema herpeticum. Herpes simplex. Consider discontinuing if lymphadenopathy of unknown etiology or acute infectious mononucleosis occurs. Consider discontinuing until warts clear if skin papillomas worsen or are unresponsive. Avoid sun, UV light. Reevaluate if no improvement after 6 weeks. Pregnancy (Cat.C). Nursing mothers: not recommended.

    Warnings/Precautions

    Risk of Immunosuppression

    • Although a causal relationship has not been established, rare cases of malignancy (eg, skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Elidel Cream, 1%.

    • Avoid continuous long-term use of topical calcineurin inhibitors in any age group and only apply to areas of involvement with atopic dermatitis.

    • Not indicated for use in children less than 2 years of age.

    • Do not use Elidel Cream in immunocompromised adults and children, including patients on systemic immunosuppressive medications.

    • Reevaluate patients and confirm diagnosis if signs and symptoms of atopic dermatitis do not improve within 6 weeks.

    • Safety of Elidel Cream has not been established beyond 1 year of non-continuous use.

    Application to Malignant or Pre-malignant Skin Conditions

    • Avoid use on malignant or premalignant skin conditions (eg, cutaneous T-cell lymphoma [CTCL]), which can present as dermatitis.

    • Do not use in patients with Netherton’s Syndrome or other skin diseases that lead to increased systemic absorption of pimecrolimus.

    • Safety of Elidel Cream has not been established in patients with generalized erythroderma.

    Bacterial and Viral Skin Infections

    • Resolve bacterial or viral infections at treatment sites prior to initiating treatment.

    • Safety and efficacy of Elidel Cream has not been evaluated for the treatment of clinically infected atopic dermatitis.

    • Treatment with Elidel Cream may be independently associated with an increased risk for varicella zoster virus infection, herpes simplex virus infection, or eczema herpeticum.

    Patients with Lymphadenopathy

    • Consider discontinuing if lymphadenopathy of unknown etiology or acute infectious mononucleosis occurs. 

    Sun Exposure

    • Minimize or avoid natural or artificial sunlight exposure.

    Immunocompromised Patients

    • Safety and efficacy in immunocompromised patients have not been studied.

    Pregnancy Considerations

    Pregnancy Category C

    • No adequate and well-controlled studies in pregnant women have been conducted.

    • Use Elidel Cream in pregnant women only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mother Considerations

    • It is not known whether this drug is excreted in human milk.

    • A decision should be made whether to discontinue nursing or to discontinue the drug.

    Pediatric Considerations

    • Not indicated for use in children less than 2 years of age.

    Elidel Pharmacokinetics

    Absorption

    • Majority of samples in adults, blood concentrations of pimecrolimus were below 0.5 ng/mL.

    Distribution

    • 99.5% plasma protein bound.

    Metabolism

    Hepatic.

    Elimination

    Fecal (78.4%).

    Elidel Interactions

    Interactions

    Caution with CYP3A inhibitors in widespread and/or erythrodermic disease.

    Elidel Adverse Reactions

    Adverse Reactions

    Local reactions (eg, burning), nasopharyngitis, pyrexia, cough, headache, others; rare: malignancy (eg, skin, lymphoma).

    Elidel Clinical Trials

    Clinical Trials

    • 3 randomized, double-blind, vehicle-controlled, multicenter phase 3 trials evaluated the efficacy and safety of Elidel in 589 patients aged 3 months to 17 years with mild to moderate atopic dermatitis. Two of the three trials support the use of Elidel Cream in patients 2 years of age and older with mild to moderate atopic dermatitis.

    • Additional data from 3 other clinical trials evaluated the safety of Elidel Cream in 1619 pediatric and adult patients with atopic dermatitis.

    • 2 identical 6-week, randomized, vehicle-controlled, multi-center, phase 3 trials evaluated Elidel Cream in 403 pediatric patients 2 to 17 years of age with mild to moderate atopic dermatitis. Patients applied either Elidel or vehicle cream twice daily to 5% to 96% of their BSA for up to 6 weeks. Results showed that 35% of Elidel-treated patients achieved clear or almost clear of signs of atopic dermatitis vs 18% of vehicle-treated patients. 

    • In two pediatric trials, Elidel Cream showed a significant treatment effect by day 15. The key signs of atopic dermatitis (eg, erythema, infiltration/papulation, lichenification, and excoriations) were also reduced at day 8 when compared to vehicle.

    Elidel Note

    Not Applicable

    Elidel Patient Counseling

    Patient Counseling

    • Do not use Elidel Cream continuously for a long time.

    • Only use on areas of skin that have eczema.

    • Do not use on a child under 2 years old.

    • Do not use sun lamps, tanningbeds, or et treatment with UV light therapy during treatment.

    • Minimize sun exposure during treatment. If the patient needs to be outdoors, then wear loose fitting clothing.

    • Do not cover skin of treatment sites with bandages, dressings, or wraps.

    • For external use only. Do not get Elidel Cream in eyes, nose, mouth, vagina, or rectum. 

    • Use Elidel Cream for short periods, and if needed, treatment may be repeated with breaks in between.

    • Use the smallest amount necessary to control the eczema.

    • Do not bathe, shower, or swim right after applying Elidel Cream.

    • If a patient uses moisturizers, apply it after using Elidel Cream.

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