Pimecrolimus Brand Name– Elidel
What is Pimecrolimus
Pimecrolimus (ASM 981), a derivative of ascomycin, is a topical macrolactam immunomodulator.
Ascomycin was originally isolated in the early 1960s from Streptomyces hygroscopics var ascomyceticus. Pimecrolimus has similar clinical effects as tacrolimus; however, they differ in therapeutic effectiveness and formulation.
Pimecrolimus has been shown to prevent atopic dermatitis flares more effectively than conventional therapy; after 6 months of treatment, 61% of patients completed treatment with pimecrolimus without a flare as compared to 35% of those treated with conventional therapy.
As opposed to topical corticosteroids, no skin atrophy is noted following pimecrolimus treatment. The FDA approved pimecrolimus cream for use in children and adults with atopic dermatitis in January 2002.
The safety and tolerability in infants and children less then 2 years of age is currently being investigated.
Data from a study released in 2005 demonstrate that pimecrolimus can maintain control of atopic dermatitis for up to 18 months without any additional treatment.
On February 15, 2005, the FDA announced the addition of a Black Box warning to the professional label for Elidel® (pimecrolimus cream), instructing prescribers to use only after failure of other eczema treatments due to a possible increased cancer risk; a Medication Guide will also accompany all prescriptions for Elidel®.
Indications
- atopic dermatitis
- lichen sclerosus
- psoriasis
For short-term and intermittent long-term treatment of mild to moderate atopic dermatitis in non-immunocompromised patients who are unresponsive or intolerant of other therapies or as an alternative to conventional therapies in at-risk patients
NOTE: Topical pimecrolimus is a second line agent to treat atopic dermatitis in patients unresponsive to or intolerant of other first line agents; long-term safety has not been established.
Side Effects
- abdominal pain
- acne vulgaris
- anaphylactoid reactions
- angioedema
- arthralgia
- back pain
- conjunctivitis
- constipation
- cough
- dental pain
- diarrhea
- dysmenorrhea
- dyspnea
- epistaxis
- erythema
- fever
- flushing
- folliculitis
- headache
- infection
- influenza
- lymphadenopathy
- nasal congestion
- nausea
- new primary malignancy
- ocular infection
- pharyngitis
- pruritus
- rhinitis
- rhinorrhea
- sinusitis
- skin discoloration
- skin irritation
- superinfection
- urticaria
- vomiting
- wheezing
Monitoring Parameters
- laboratory monitoring not necessary
- skin cancer screening exam
Contraindications
- breast-feeding
- children
- herpes infection
- ichthyosis
- immunosuppression
- infants
- lymphoma
- mononucleosis
- neonates
- new primary malignancy
- occlusive dressing
- pregnancy
- skin cancer
- sunlight (UV) exposure
- varicella
- viral infection
Interactions
- Ethanol
Ethanol: (Moderate) A flushing syndrome has been reported in patients treated with topical pimecrolimus upon ingestion of ethanol. The flushing occurred in the face or at the sites of medication application, usually within 5-15 minutes of ethanol ingestion, and lasted for an average duration of 1 hour. Roughly 3-7 percent of patients report redness and warm sensations, which sometimes result in discomfort.
