Alitretinoin

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Panretin® may be confused with pancreatin

High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

U.S. BRAND NAMES — Panretin®

PHARMACOLOGIC CATEGORY
Antineoplastic Agent, Miscellaneous
Retinoic Acid Derivative

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:
Panretin®: 0.1% (60 g)

DOSAGE FORMS: CONCISE
Gel:
Panretin®: 0.1% (60 g)

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 — There are no known significant interactions.

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.

CANADIAN BRAND NAMES — Panretin®

INTERNATIONAL BRAND NAMES — Panretin (AR, AT, BE, BG, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HN, 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