Uses
Atopic Dermatitis
Second-line therapy for short-term treatment and noncontinuous chronic treatment of mild to moderate atopic dermatitis (eczema) in immunocompetent adults and children ≥2 years of age who are unable to tolerate or have not responded to first-line therapies (e.g., corticosteroids) or for whom first-line therapies are inadvisable. (See Carcinogenicity under Cautions.)
Not indicated for use in children <2 years of age.
Dosage and Administration
Administration
Topical Administration
Apply topically to the skin as a 1% cream. For external use only; do not use in the eyes or ingest.
Apply in thin layers to affected areas of skin.
Use minimum amount required to control symptoms; limit application to areas affected with atopic dermatitis. (See Carcinogenicity under Cautions.)
Do not use occlusive dressings or wrappings.
Dosage
Pediatric Patients
Atopic Dermatitis
Topical
Children ≥2 years of age: Apply to affected areas twice daily.
Treatment effects usually evident within 15 days; erythema and infiltration or papulation generally reduced within 8 days. Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema). If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.
Adults
Atopic Dermatitis
Topical
Apply to affected areas twice daily.
Treatment effects usually evident within 15 days; erythema and infiltration or papulation generally reduced within 8 days. Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema). If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.
Prescribing Limits
Pediatric Patients
Atopic Dermatitis
Topical
For short-term and intermittent use only; avoid continuous long-term use. Safety of noncontinuous use for >1 year not established. (See Carcinogenicity under Cautions.)
Adults
Atopic Dermatitis
Topical
For short-term and intermittent use only; avoid continuous long-term use. Safety of noncontinuous use for >1 year not established. (See Carcinogenicity under Cautions.)
Cautions
Contraindications
Warnings/Precautions
Warnings
Carcinogenicity
Possible increased risk of malignancies. (See Boxed Warning.)
Malignancies (including lymphoma and skin cancers) reported rarely in children and adults receiving topical pimecrolimus. Concerns also based on case reports of malignancies (including lymphoma and skin cancers) in patients (including transplant patients) receiving prolonged systemic treatment with calcineurin inhibitors (e.g., cyclosporine, tacrolimus); animal studies indicating dose-related increases in the risk of lymphoma and other malignancies with pimecrolimus and other calcineurin inhibitors; and known pharmacologic effects of these immunosuppressants.
Animal studies using topically or orally administered pimecrolimus in 3 species (mouse, rat, monkey) indicate increased risk of lymphoma and other malignancies (possibly due to immunosuppression); risk appears to be related to dose and duration of exposure.
Risk associated with systemic therapy is related to intensity and duration of immunosuppression. The potential for systemic immunosuppression with topical pimecrolimus and the drug’s role in the development of malignancies in humans have not been established. Long-term studies in humans are needed to determine whether topical pimecrolimus is associated with an increased risk of malignancies. Until such data are available, FDA recommends limiting use to the labeled indication, reserving the drug for use as a second-line agent for short-term and intermittent treatment. (See Atopic Dermatitis under Uses, see Immunocompromised Patients under Cautions, and see Dosage and Administration.) Carefully evaluate potential risks and benefits of therapy.
Avoid use for malignant or premalignant skin conditions (e.g., cutaneous T-cell lymphoma [CTCL]), which may appear clinically similar to dermatitis.
General Precautions
Lymphadenopathy
Lymphadenopathy reported; usually related to infections and resolves following appropriate anti-infective therapy. Also reported in association with malignancy. Investigate etiology if lymphadenopathy develops. Discontinue pimecrolimus in the absence of a clear etiology or in the presence of acute infectious mononucleosis. Monitor patients with lymphadenopathy to ensure that it resolves.
Netherton’s Syndrome
Not recommended for use in patients with Netherton’s syndrome because of the potential for increased systemic absorption of pimecrolimus.
Generalized Erythroderma
Safety in patients with generalized erythroderma has not been established.
Dermatologic Reactions
Mild to moderate sensation of warmth and/or burning, stinging, soreness, and pruritus at the treatment site may occur within 1–5 days of initiating therapy. Reactions usually last no more than 5 days and improve as the lesions of atopic dermatitis resolve.
Infectious Complications
Clinical infections (e.g., bacterial, viral) at treatment sites should be resolved before initiating pimecrolimus therapy. Safety and efficacy not established for treatment of clinically infected atopic dermatitis.
Possible increased risk of varicella-zoster infections (chickenpox or shingles), herpes simplex virus infection, or eczema herpeticum.
Skin papilloma and/or warts may occur. If skin papilloma worsens or is unresponsive to conventional therapy, consider discontinuing pimecrolimus until complete resolution of the warts is achieved.
Septic arthritis reported in infants ≤1 year of age during clinical trials; however, causality not established.
Phototoxicity
Although phototoxicity not reported in humans, it may be prudent to minimize or avoid natural or artificial sunlight exposure during pimecrolimus therapy (including periods when no drug is on skin). Potential effects on skin response to ultraviolet (UV) damage are not known.
Animal photocarcinogenicity studies indicate shortened time to skin tumor formation following chronic topical pimecrolimus dosing with concurrent UV radiation exposure.
Immunocompromised Patients
Safety and efficacy not established and not recommended for use in immunocompromised adults or children.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether distributed into milk. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established and not recommended for use in children <2 years of age.
Increased incidence of upper respiratory tract infections in infants <24 months of age receiving pimecrolimus compared with those receiving placebo. Possible increased incidence of upper respiratory symptoms and/or infections in infants 3–23 months of age compared with older children; relationship to treatment not known.
Long-term effects on the developing immune system in infants and children are not known.
Not recommended for use in immunocompromised children.
Geriatric Use
Experience insufficient to determine whether patients ≥65 years of age respond differently than younger adults.
Common Adverse Effects
Upper respiratory tract infection, cough, nasopharyngitis, application site reactions (e.g., sensation of burning or warmth), headache.
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