Antineoplastic Agent, Miscellaneous

Topical treatment of cutaneous lesions in AIDS-related Kaposi's sarcoma; not indicated when systemic therapy for Kaposi's sarcoma is indicated

D

Potentially teratogenic and/or embryotoxic; limb, craniofacial, or skeletal defects have been observed in animal models. If used during pregnancy or if the patient becomes pregnant while using alitretinoin, the woman should be advised of potential harm to the fetus. Women of childbearing potential should avoid becoming pregnant. Excretion in human breast milk is unknown; women are advised to discontinue breast-feeding prior to using this medication.

Hypersensitivity to alitretinoin, other retinoids, or any component of the formulation

May cause fetal harm if absorbed by a woman who is pregnant. Patients with cutaneous T cell lymphoma have a high incidence of treatment-limiting adverse reactions. May be photosensitizing (based on experience with other retinoids); minimize sun or other UV exposure of treated areas. Do not use concurrently with topical products containing DEET (increased toxicity may result). Safety in pediatric patients or geriatric patients has not been established. Occlusive dressing should not be used.

>10%:

Central nervous system: Pain (0% to 34%)

Dermatologic: Rash (25% to 77%), pruritus (8% to 11%)

Neuromuscular & skeletal: Paresthesia (3% to 22%)

5% to 10%:

Cardiovascular: Edema (3% to 8%)

Dermatologic: Exfoliative dermatitis (3% to 9%), skin disorder (0% to 8%)

There has been no experience with human overdosage of alitretinoin, and overdose is unlikely following topical application; treatment is symptomatic and supportive

Increased toxicity of DEET may occur if products containing this compound are used concurrently with alitretinoin. Due to limited absorption after topical application, interaction with systemic medications is unlikely.

Store at room temperature

Binds to retinoid receptors to inhibit growth of Kaposi's sarcoma

Absorption: Indirect evidence suggests absorption after topical application is not extensive

Topical: Apply gel twice daily to cutaneous Kaposi's sarcoma lesions

No information available to require special precautions

No effects or complications reported

For external use only. Use exactly as directed; do not overuse. Avoid use of any product such as insect repellents which contain DEET (check with your pharmacist). Wear protective clothing and or avoid exposure to direct sun or sunlamps. Wash hands thoroughly before applying. Avoid applying skin products that contain alcohol of harsh chemicals during treatment. Do not apply occlusive dressings. Stop treatment and inform prescriber if rash, skin irritation, redness, scaling, or excessive dryness appears. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication; use appropriate barrier contraceptive measures. Breast-feeding is not recommended.

Gel: 0.1%, 60 g tube