Pimecrolimus (Elidel) Contraindications and Precautions
- occlusive dressing
- breast-feeding
- children
- herpes infection
- ichthyosis
- immunosuppression
- infants
- infection
- lymphoma
- mononucleosis
- neoplastic disease
- pregnancy
- skin cancer
- sunlight (UV) exposure
- varicella
- viral infection
Pimecrolimus (Elidel) Contraindications and Precautions
The safety of pimecrolimus cream under occlusion, which may promote systemic absorption, has not been evaluated. Pimecrolimus cream should not be used with an occlusive dressing.
Pimecrolimus cream should not be applied to areas of active cutaneous viral infection. Before initiating pimecrolimus therapy clinical infections should be cleared. Although patients with atopic dermatitis are predisposed superficial herpes infection (e.g., eczema herpeticum, Kaposi’s varicelliform eruption), treatment with pimecrolimus cream may be associated with an increased risk of varicella zoster virus infection (chickenpox or shingles), herpes simplex infection, or eczema herpeticum. In the presence of these infections, the risks and benefits associated with pimecrolimus treatment must be considered.
Despite the absence of observed phototoxicity in humans, pimecrolimus cream shortened the time to skin tumor formation in an animal photo-carcinogenicity study. The enhancement of ultraviolet (UV) carcinogenicity is not necessarily dependent on phototoxic mechanisms. However, it is prudent for patients to minimize or avoid artificial or natural sunlight (UV) exposure during treatment with pimecrolimus cream.
Pimecrolimus cream is not for use in children or infants < 2 years of age. However, two phase III studies have examined the use of pimecrolimus cream in pediatric patients 3 months to 2 years of age. Adverse reactions occurred more frequently in infants treated with pimecrolimus cream versus placebo. Also, although not causally established, a higher incidence of upper respiratory symptoms/infections occurred in children 3 - 23 months of age as compared with patients 2 - 14 years of age. The effect of pimecrolimus cream on the developing immune system of infants is unknown.
Pimecrolimus cream should only be prescribed as directed and only after other eczema treatments have failed due to a possible risk of neoplastic disease (cancer), especially skin cancer or lymphoma. The FDA has added a black box warning regarding this risk to the professional labeling. To date, there have been reports of cancers in three different animal species. The risk increased as the drug dosage increased. There have also been a small number of cancers reported in children and adults using pimecrolimus cream. The manufacturer will begin conducting research to determine the risk of cancers to humans during pimecrolimus treatment. There are no data to support the use of pimecrolimus cream in patients with immunosuppression. Increased susceptibility to infection and possible development of neoplastic disease, especially skin cancer or lymphoma, may result from immunosuppression (see Adverse Reactions). Patients who receive pimecrolimus cream and develop a new or changed skin lesion or lymphadenopathy should have the lesion or the etiology of their lymphadenopathy investigated due to the risk of cancer. In the absence of a clear etiology for the lymphadenopathy or in the presence of cancer or acute infectious mononucleosis, discontinuation of pimecrolimus treatment should be considered. Monitor patients to assure that the lymphadenopathy resolves.
The use of pimecrolimus cream in patients with ichthyosis, specifically Netherton’s syndrome (congenital ichthyosiform erythroderma), is not recommended due to the potential for increased absorption of pimecrolimus.
Pimecrolimus cream is classified as FDA pregnancy risk category C. There are no adequate and well-controlled studies of topically administered pimecrolimus in pregnant women. The experience with pimecrolimus cream when used by pregnant women is too limited to permit assessment of its safety during pregnancy.
It is not known whether pimecrolimus is excreted into breast milk. Because of the potential of serious adverse reactions in the infant, women should continue breast-feeding only when the benefits justify the risks.
[ Last revised: 1/25/2006 3:11:00 PM ]
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