Overview
11 DESCRIPTION PANRETIN GEL is a retinoid. PANRETIN GEL 0.1% contains alitretinoin and is intended for topical application only. The chemical name is (2E,4E,6Z,8E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid, also known as 9-cis-retinoic acid. Chemically, alitretinoin is related to vitamin A. It is a yellow powder with a molecular weight of 300.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 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. 12.2 Pharmacodynamics Alitretinoin exposure-response relationships and the time course of pharmacodynamic response are unknown. 12.
Indications
- 1 INDICATIONS AND USAGE 1.1 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 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS).
Common Doses
- Refer to label
Dosage
2 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.
Contraindications
- 4 CONTRAINDICATIONS PANRETIN GEL is contraindicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product. Hypersensitivity to retinoids or any component of PANRETIN GEL ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Photosensitivity [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (> 5%) at the application site are rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.