Alitretinoin

U.S. BRAND NAMES — Panretin®
PHARMACOLOGIC CATEGORY Antineoplastic Agent, Miscellaneous
DOSING: ADULTS Kaposi's sarcoma: Topical: Apply gel twice daily to cutaneous lesions.
T-cell lymphomas (unlabeled use): Topical: Apply gel twice daily to cutaneous lesions.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel: 0.1% (60 g tube)
DOSAGE FORMS: CONCISE Gel: Panretin®: 0.1% (60 g tube)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Do not use occlusive dressings.
USE — Orphan drug: Topical treatment of cutaneous lesions in AIDS-related Kaposi's sarcoma
USE - UNLABELED / INVESTIGATIONAL — Cutaneous T-cell lymphomas
ADVERSE REACTIONS SIGNIFICANT >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%)
CONTRAINDICATIONS — Hypersensitivity to alitretinoin, other retinoids, or any component of the formulation; pregnancy
WARNINGS / PRECAUTIONS Special handling: Hazardous agent: Use appropriate precautions for handling and disposal.
Concerns related to adverse effects: Photosensitivity: May be photosensitizing (based on experience with other retinoids); minimize sun or other UV exposure of treated areas.
Concurrent drug therapy issues: Products containing DEET: Do not use concurrently with topical products containing DEET.
Special populations: Elderly: Safety has not been established in the elderly. Pediatrics: Safety has not been established in children. Pregnancy: May cause fetal harm if absorbed by a woman who is pregnant.
DRUG INTERACTIONS — 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.
PREGNANCY RISK FACTOR — D (show table)
PREGNANCY IMPLICATIONS — 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.
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Excretion in human breast milk is unknown; women are advised to discontinue breast-feeding prior to using this medication.
TOXICOLOGY / OVERDOSE COMPREHENSIVE — There has been no experience with human overdosage of alitretinoin, and overdose is unlikely following topical application. Treatment is symptomatic and supportive.
CANADIAN BRAND NAMES — Panretin®
INTERNATIONAL BRAND NAMES — Panretin (AR, AT, BE, BG, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HU, IE, IT, NL, NO, PT, RU, SE, TR)
MECHANISM OF ACTION — Binds to retinoid receptors to inhibit growth of Kaposi's sarcoma
PHARMACODYNAMICS / KINETICS — Absorption: Not extensive
PATIENT INFORMATION — For external use only; avoid UV light exposure (sun or sunlamps) of treated areas; avoid DEET-containing products