brand elidel 1% cream

Uses

Atopic Dermatitis

Pimecrolimus 1% cream is used topically as 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 and older who are unable to tolerate or have not responded to first-line therapies (e.g., corticosteroids) or in whom first-line therapies are inadvisable because of potential risks. Because of the potential for increased risk of malignancies, pimecrolimus 1% cream should be used only as a second-line agent for short-term and intermittent treatment. (See Carcinogenicity under Warnings/Precautions: Warnings, in Cautions.)

Pimecrolimus topical cream is not indicated for use in children younger than 2 years of age. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Efficacy of pimecrolimus 1% cream in the treatment of atopic dermatitis was established principally in 2 randomized, double-blind, vehicle-controlled, multicenter clinical studies of 6 weeks' duration in children 2-17 years of age. In these clinical studies, topical application of pimecrolimus 1% cream to atopic dermatitis lesions involving approximately 5-96% of the body surface area twice daily for up to 6 weeks produced substantial clinical improvement, decreased the percentage of body surface area affected, and alleviated the signs and symptoms of the disease (e.g., pruritus). Such treatment effects usually were evident within 15 days, with signs and symptoms of the disease such as erythema and infiltration or papulation generally reduced within 8 days of initiating pimecrolimus therapy.

Dosage and Administration

General

Pimecrolimus is applied topically to the skin as a 1% cream. Occlusive dressings or wrappings should not be used concomitantly.

For the treatment of mild to moderate atopic dermatitis in adults or children 2 years of age and older, a thin layer of cream should be applied to affected areas twice daily. The minimum amount required to control symptoms should be used and application limited to areas affected with atopic dermatitis. (See Carcinogenicity under Warnings/Precautions: Warnings, in Cautions.)

Treatment should be discontinued following resolution of signs and symptoms of atopic dermatitis (e.g., pruritus, rash, erythema). Patients should be reevaluated and their diagnosis confirmed if manifestations of the disease persist beyond 6 weeks.

Pimecrolimus topical cream is intended for short-term and intermittent use only and should not be used continuously. The safety of noncontinuous use of topical pimecrolimus cream for longer than 1 year has not been established. (See Carcinogenicity under Warnings/Precautions: Warnings, in Cautions.)

Special Populations

No special population dosage recommendations at this time.

Cautions

Contraindications

Known hypersensitivity to pimecrolimus or any ingredient in the formulation.

Warnings/Precautions

Warnings

Carcinogenicity

The long-term safety of topical pimecrolimus therapy has not been established. Although a causal relationship has not been established, malignancies (e.g., skin cancer, lymphoma) have been reported rarely in patients treated with topical calcineurin inhibitors, including topical pimecrolimus cream. Because of a possible increase in the risk of malignancies associated with topical pimecrolimus therapy, continuous long-term use of topical pimecrolimus cream should be avoided in patients of any age, and application limited to areas affected with atopic dermatitis. Topical pimecrolimus is not indicated for use in children younger than 2 years of age.

The concern for increased risk of malignancies is based principally on case reports of malignancies (including lymphoma and skin cancer) in children and adults receiving topical pimecrolimus or tacrolimus; the increased risk of lymphoma and skin cancer associated with prolonged systemic therapy with calcineurin inhibitors (e.g., cyclosporine, tacrolimus) in transplant patients; animal studies indicating dose-related increases in the risk of lymphoma and other malignancies with pimecrolimus and other calcineurin inhibitors; and the known pharmacologic effects of these immunosuppressants. The potential risks and benefits of therapy should be carefully evaluated.

Animal studies using topically or orally administered pimecrolimus in 3 species (mouse, rat, monkey) indicate an increased risk of lymphoma and other malignancies, possibly secondary to immunosuppression; the risk of malignancy appears to be related to dose and duration of exposure to the drug.

The risk associated with systemic therapy with calcineurin inhibitors 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, the US Food and Drug Administration (FDA) recommends that use of topical pimecrolimus be limited to the labeled indication and that the drug be reserved for use as a second-line agent for short-term and intermittent treatment. (See Uses: Atopic Dermatitis, see Carcinogenicity under Warnings/Precautions: Warnings, in Cautions, and see Dosage and Administration: General.)

Topical pimecrolimus therapy should be avoided for malignant or premalignant skin conditions (e.g., cutaneous T-cell lymphoma [CTCL]), which may appear clinically similar to dermatitis.

Because of a potential increased risk for skin cancer, it is prudent for patients to limit exposure to sunlight or other UV light.

General Precautions

Lymphadenopathy

Immunosuppression potentially may result in the development of lymphoma. In clinical studies, lymphadenopathy was reported in 0.9% of patients receiving topical pimecrolimus cream; lymphadenopathy usually was related to infections and resolved following appropriate antimicrobial therapy. Lymphadenopathy in association with malignancy also has been reported during postmarketing surveillance. Patients who develop lymphadenopathy while receiving pimecrolimus cream should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, pimecrolimus cream should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.

Netherton's Syndrome

Use of topical pimecrolimus cream in patients with Netherton's syndrome is not recommended because of the potential for increased systemic absorption of pimecrolimus.

Generalized Erythroderma

The safety of topical pimecrolimus cream in patients with generalized erythroderma has not been established.

Dermatologic Reactions

A mild to moderate sensation of warmth and/or burning may occur at the treatment site within 1-5 days of initiating topical pimecrolimus therapy. Such reactions usually last no more than 5 days and improve as the lesions of atopic dermatitis resolve. Patients should be advised to notify a clinician if such reactions are severe or persist longer than 1 week.

Infectious Complications

Safety and efficacy of topical pimecrolimus cream for the treatment of clinically infected atopic dermatitis have not been established. The manufacturer recommends that bacterial or viral infections at treatment sites be resolved before initiating topical pimecrolimus therapy. Topical use of pimecrolimus cream may be associated with an increased risk of varicella-zoster infections (chickenpox or shingles), herpes simplex virus infection, or eczema herpeticum.

Skin papilloma or warts were reported in 1% of patients receiving topical pimecrolimus cream in clinical studies. If skin papilloma worsens or is unresponsive to conventional therapy, discontinuance of the drug until complete resolution of the warts is achieved should be considered.

Phototoxicity

Although phototoxicity has not been reported in humans treated with topical pimecrolimus cream, it may be prudent to minimize or avoid natural or artificial sunlight exposure during pimecrolimus therapy (including periods when no drug is on the skin). The potential effects of topical pimecrolimus cream on skin response to ultraviolet (UV) damage are not known.

Animal photocarcinogenicity studies indicate a shortened time to skin tumor formation following chronic topical pimecrolimus dosing with concurrent UV radiation exposure.

Immunocompromised Patients

Pimecrolimus cream should not be used in immunocompromised adults or children. Safety and efficacy of topical pimecrolimus cream have not been established in such patients.

Specific Populations

Pregnancy

Category C. (See Users Guide.)

Lactation

Not known whether pimecrolimus is distributed into milk. Discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Pediatric Use

Safety and efficacy of topical pimecrolimus not established in children younger than 2 years of age. Not recommended for use in children younger than 2 years of age. In clinical trials, an increased incidence of upper respiratory tract infections was observed in children younger than 2 years of age receiving pimecrolimus cream compared with those receiving placebo. In pharmacokinetic studies, following multiple topical applications of pimecrolimus 1% cream, a higher incidence of upper respiratory symptoms and/or infections was observed in infants 3-23 months of age than in older children; however, the relationship to pimecrolimus therapy is not known.

Not recommended for use in immunocompromised children. Long-term effects on the developing immune system in infants and children are not known.

Geriatric Use

Experience with topical pimecrolimus therapy in those 65 years of age and older insufficient to determine whether they respond differently than younger adults.

Common Adverse Effects

The most common adverse effects of topical pimecrolimus therapy are upper respiratory tract infection, cough, nasopharyngitis, application site reactions (e.g., sensation of burning or warmth), and headache. In addition, an increased incidence of impetigo, skin infection, superinfection (i.e., infected atopic dermatitis), rhinitis, and urticaria has been reported in patients receiving topical pimecrolimus 1% cream and topical corticosteroids sequentially compared with those receiving pimecrolimus 1% cream alone.

Drug Interactions

No formal drug interaction studies have been performed.

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction with inhibitors of cytochrome P-450 (CYP) 3A4 isoenzyme (e.g., erythromycin, azole antifungal agents, calcium-channel blocking agents, cimetidine) in patients with widespread and/or erythrodermic disease.