Alitretinoin (1 brand name, 1 dosage form, 1 route)
Available dosage forms: GEL.
Routes of administration: TOPICAL.
Brand Names
- PANRETIN
Indications and Usage
Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies (14.1)].
Dosage and Administration
PANRETIN GEL is for topical use only. Do not use occlusive dressings with PANRETIN GEL. Apply PANRETIN GEL twice daily to coat the entire cutaneous Kaposi sarcoma lesions. Gradually increase the application frequency up to four (4) times a day as tolerated. Continue PANRETIN GEL as long as patient is deriving benefit. Reduce application frequency for application site toxicity. Interrupt treatment for severe irritation; may resume at a reduced application frequency once symptoms improve. Avoid application of gel to normal skin and do not apply on or near mucosal surfaces. Wash hands after application unless gel is applied to Kaposi sarcoma lesions on the hands. Allow gel to dry for three to five minutes before covering with clothing.
Contraindications
PANRETIN GEL is contraindicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product.
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: • Photosensitivity [see Warnings and Precautions (5.2)]
Mechanism of Action
Alitretinoin (9-cis-retinoic acid) is a naturally occurring endogenous retinoid that binds to and activates all known intracellular retinoid receptor subtypes (RARα, RARβ, RARγ, RXRα, RXRβ and RXRγ). Once activated these receptors function as transcription factors that regulate the expression of genes that control the process of cellular differentiation and proliferation in both normal and neoplastic cells. Alitretinoin inhibits the growth of Kaposi’s sarcoma (KS) cells in vitro.