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 ?
Meda's key products include the allergy therapy Dymista (azelastine/fluticasone) and Elidel (pimecrolimus) for dermatitis and eczema.
Meda's Elidel contains the molecule pimecrolimus and akin to Astellas' Protopic belongs to the ascomycin class of macrolactam immunosuppressives.
The effect of the unlawful marketing resulted in the Texas Medicaid program overpaying for Elidel prescriptions.
At the end of 2011 Meda opened its China affiliate, based in Beijing and it will begin by commercialising two of its products in Hong Kong, Elidel for the treatment of atopic dermatitis and azelastine for the treatment of allergic rhinitis.
30 June 2011 - Swedish pharma company Meda AB (STO: MEDA A) said today it has licenced to Canada-based Valeant Pharmaceuticals Intl Inc (NYSE: VRX) (TSX: VRX) the exclusive rights for the Elidel and Xerese creams for the USA, Canada and Mexico.
Rothman) ("[T]he black box warning has brought about a marked unwillingness among both physicians and patients to use this valuable addition [Protopic ointment and Elidel cream] to treatment options for atopic dermatitis, a difficult disorder.
100) In this case, an infant developed lymphoma six months after commencing use of Elidel, a prescription drug for eczema.
and corticosteroids or newer biologics such as Elidel (pimecrolimus) and Prograf (tacrolimus).
Newer therapies available include Protopic (tacrolimus) ointment and Elidel (pimecrolimus) cream.