Elidel

pimecrolimus

Elidel

Pharmacologic class: Dermatologic agent

Therapeutic class: Immunomodulator

Pregnancy risk category C

FDA Box Warning

• Drug's long-term safety hasn't been established.

• Rare cases of lymphoma and skin cancer have occurred in patients who used drug. Avoid continuous long-term use in any age-group and limit application to areas of atopic dermatitis.

• Drug isn't indicated for use in children younger than age 2.

Action

Unknown. Thought to inhibit T-cell activation by blocking transcription of early cytokines. Also blocks release of inflammatory cytokines and mediators from mast cells after stimulation by antigen/immunoglobin E.

Availability

Cream: 1%

Indications and dosages

Mild to moderate atopic dermatitis

Adults and children ages 2 and older: Apply 1% cream topically b.i.d. to clean, dry, affected area.

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• eczema herpeticum (Kaposi's varicelliform eruption), varicella zoster (chickenpox or shingles), herpes simplex infection, lymphadenopathy, mononucleosis, acute infectious Netherton's syndrome, skin infections or papilloma, warts, immunocompromised state
• concurrent use of CYP3A inhibitors
• pregnant or breastfeeding patients
• children younger than age 2 (safety not established).

Administration

• Apply thin layer to affected area.
• Don't use with occlusive dressing (may increase systemic absorption).

Adverse reactions

CNS: headache

EENT: sinus congestion, rhinorrhea

GI: nausea, vomiting, diarrhea, gastritis

Respiratory: upper respiratory tract infection

Skin: pruritus, application-site reaction or discomfort

Other: pyrexia, increased risk of viral or bacterial infections

Interactions

Drug-drug.CYP3A inhibitors (such as calcium channel blockers, cimetidine, erythromycin): inhibition of action by hepatic enzymes that eliminate pimecrolimus

Drug-behaviors.Sunbathing: possible increased risk of skin cancer

Patient monitoring

• Reevaluate at 6 weeks if lesions haven't healed.
• Discontinue therapy, as prescribed, if disease resolves.

Patient teaching

• Tell patient to apply to clean, dry skin and to wash hands afterward (unless hands are being treated).
• Caution patient not to use occlusive dressings.
• Tell patient drug may cause local reaction, such as a feeling of warmth or burning sensation. Advise him to contact prescriber if reaction is severe or lasts more than 1 week.
• Advise patient to apply missed dose as soon as possible. If it's almost time for next dose, tell him to skip missed dose and resume regular schedule.
• Tell patient to avoid natural or artificial sunlight and to use adequate sunblock on skin and lips.
• Instruct patient to contact prescriber if no improvement occurs after 6 weeks or if condition worsens.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

pimecrolimus

(pi-me-cro-li-mus) ,

Elidel

(trade name)

Classification

Therapeutic: immunosuppressants

Indications

Short-term and intermittent long-term management of mild to moderate atopic dermatitis unresponsive to or in patients intolerant of conventional treatment.

Action

Inhibits T-cell and mast cell activation by interfering with production of inflammatory cytokines.

Therapeutic effects

Decreased severity of atopic dermatatis.

Pharmacokinetics

Absorption: Minimally absorbed through intact skin.
Distribution: Local distribution after topical administration.
Metabolism and Excretion: Systemic metabolism and excretion is negligible with local application.
Half-life: Not applicable.

Time/action profile (improvement in symptoms)

ROUTEONSETPEAKDURATION
topicalwithin 6 daysunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Should not be applied to areas of active cutaneous viral infections (↑ risk of dissemination);Concurrent use of occlusive dressings;Netherton’s syndrome (↑ absorption of pimecrolimus); Lactation: Discontinue breast feeding.
Use Cautiously in: Possible risk of cancer. Do not use as first-line therapy;Clinical infection at treatment site (infection should be treated/cleared prior to use);Skin papillomas (warts); allow treatment/resolution prior to use;Natural/artificial sunlight (minimize exposure); Obstetric: Use only if clearly needed; Pediatric: Children <2 yr (safety not established); use only if other treatments have failed.

Adverse Reactions/Side Effects

Local

  • burning (most frequent)

Miscellaneous

  • ↑ risk of lymphoma/skin cancer

Interactions

Drug-Drug interaction

None significant as systemic absorption is negligible.

Route/Dosage

Topical (Adults and Children ≥2 yr) Apply thin film twice daily; rub in gently and completely.

Availability

Cream: 1%

Nursing implications

Nursing assessment

  • Assess skin lesions prior to and periodically during therapy. Discontinue therapy after signs and symptoms of atopic dermatitis have resolved. Resume treatment at the first signs and symptoms of recurrence.

Potential Nursing Diagnoses

Impaired skin integrity (Indications)

Implementation

  • Topical: Apply a thin layer to affected area twice daily and rub in gently and completely. May be used on all skin areas including head, neck, and intertriginous areas. Do not use with occlusive dressings.

Patient/Family Teaching

  • Instruct patient on correct technique for application. Apply only as directed to external areas. Wash hands following application, unless hands are areas of application. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
  • Caution patient to avoid exposure to natural or artificial sunlight, including tanning beds, while using cream.
  • Advise patient that pimecrolimus may cause skin burning. This occurs most commonly during first few days of application, is of mild to moderate severity, and improves within 5 days or as atopic dermatitis resolves.
  • Advise patient to notify health care provider if no improvement is seen following 6 wk of treatment or at any time if condition worsens.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of atopic dermatitis.

Elidel

A brand name for PIMECROLIMUS.
References in periodicals archive ?
Elidel is the leading immunosuppressant topical therapy for the short-term treatment of atopic dermatitis.
2 Further Clinical Development of Elidel to Stimulate Sales Growth?
NYSE: VRX) (TSX: VRX) announced today that its subsidiary, Valeant International (Barbados) SRL (VIB), has signed an agreement to acquire rights to both Elidel (pimecrolimus 1% cream) and Xerese (acyclovir and hydrocortisone cream 5%/1%) from Meda, an international specialty pharmaceutical company (listed on Nasdaq Nordic Exchange in Stockholm) for the U.
Future entrants to the atopic dermatitis market will benefit from the strategies used by Novartis for Elidel such as a rapid global rollout and broad marketing campaign.
Monday, 5/16 - The Pediatric Advisory Committee will discuss pediatric-focused safety reviews for a number of products as well as discuss Topical Calcineurin Inhibitors Elidel and Protopic.
Immunosuppressant creams such as Protopic and Elidel are new GP-prescribed treatments that may reduce inflammation in eczema that's unresponsive to steroid cream.
7 Meda/Valeant: Elidel ($m), AGR (%), CAGR (%), 2012-2024 Table 9.
Clinical studies in more than 21,000 patients, including 3,500 infants and 7,500 children, and experience in more than 6 million patients world-wide show that Elidel has a favorable safety profile and is not associated with an increased risk of malignancy.
At Novartis, he was instrumental in developing many drugs including Ilaris (Canakinumab), Secukinumab, Elidel, and Gilenya.
Meda will begin by commercializing two of its well-established products in Hong Kong; Elidel for the treatment of atopic dermatitis (eczema) and azelastine for the treatment of allergic rhinitis (AR).
Two FDA-approved topical medications, Protopic (tacrolimus) and Elidel (pimecrolimus) are available for the treatment of eczema.
A spokeswoman for Elidel manufacturer Novartis Pharmaceuticals Corp.