Not extensive

Topical treatment of cutaneous lesions in AIDS-related Kaposi's sarcoma. Not indicated when systemic therapy is necessary (eg, >10 new lesions in previous month, symptomatic visceral involvement, symptomatic pulmonary Kaposi’s sarcoma, symptomatic lymphedema)

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

Kaposi's sarcoma: Topical: Initial: Apply gel twice daily to cutaneous lesions; may gradually increase application frequency to 3-4 times daily based on lesion tolerance. Response may be observed within 2 weeks of initiation, but typically a longer period is required (some patients have required >14 weeks). Continue therapy for as long as patients derives benefit (in clinical trials, therapy lasted up to 96 weeks).

No dosage adjustment provided in manufacturer's labeling; however, systemic absorption is not extensive making the need for a dose adjustment appear unlikely.

No dosage adjustment provided in manufacturer's labeling; however, systemic absorption is not extensive making the need for a dose adjustment appear unlikely.

Reduce application frequency for application site toxicity; for severe reactions, temporarily discontinue therapy until symptoms resolve.

Apply sufficient gel to cover lesion(s) with a generous coating; allow gel to dry 3-5 minutes after application before covering with clothing. Do not use occlusive dressings. Avoid applying gel to normal skin surrounding lesions. Do not apply to any lesions on or near mucosal surfaces.

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy

Estrogen Derivatives (Contraceptive): Retinoic Acid Derivatives may diminish the therapeutic effect of Estrogen Derivatives (Contraceptive). Two forms of contraception are recommended in females of child-bearing potential during retinoic acid derivative therapy. Monitor therapy

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives.Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Progestins (Contraceptive): Retinoic Acid Derivatives may diminish the therapeutic effect of Progestins (Contraceptive). Retinoic Acid Derivatives may decrease the serum concentration of Progestins (Contraceptive). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Particularly, microdosed progesterone-only preparations may be inadequately effective. Consider therapy modification

Tetracyclines: May enhance the adverse/toxic effect of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Avoid combination

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

>10%:

Central nervous system: Pain (≤34%), paresthesia (3% to 22%)

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

1% to 10%:

Cardiovascular: Edema (3% to 8%)

Dermatologic: Exfoliative dermatitis (3% to 9%), dermatological disease (≤8%)

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 (eg, insect repellant).

Special populations:

• Pregnancy: May cause fetal harm if significant absorption occurs in a woman who is pregnant.

D

Adverse events were observed in animal reproduction studies using an oral preparation; studies have not been conducted using the topical product. Alitretinoin may cause fetal harm if significant absorption occurs in a woman who is pregnant. Women of childbearing potential should avoid becoming pregnant.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber burning or numbness feeling, edema, or severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.