PANRETIN- alitretinoin gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALITRETINOIN (UNII: 1UA8E65KDZ) (ALITRETINOIN - UNII:1UA8E65KDZ)

Available from:

Concordia Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Panretin® gel is indicated for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma. Panretin® gel is not indicated when systemic anti-KS therapy is required (e.g., more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement). There is no experience to date using Panretin® gel with systemic anti-KS treatment. Panretin® gel is contraindicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product.

Product summary:

Panretin® gel is available in tubes containing 60 grams, (60 mg active ingredient alitretinion). NDC 59212-601-22 Store at 25º C (77º F); excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature]. Manufactured for: Concordia Pharmaceuticals Distributed by: Amdipharm Limited                           17 Northwood House                           Dublin 9, Ireland Panretin® is a registered trademark under exclusive license to Amdipharm Limited. © 2019. All rights reserved. (Rev. 05/2020)

Authorization status:

New Drug Application

Summary of Product characteristics

PANRETIN - ALITRETINOIN GEL
CONCORDIA PHARMACEUTICALS INC.
----------
PANRETIN GEL
PANRETIN®
(ALITRETINOIN)
GEL 0.1%
(FOR TOPICAL USE ONLY)
RX ONLY
DESCRIPTION
Panretin gel 0.1% contains alitretinoin and is intended for topical
application only. The
chemical name is 9-_cis_-retinoic acid and the structural formula is
as follows:
Chemically, alitretinoin is related to vitamin A. It is a yellow
powder with a molecular
weight of 300.44 and a molecular formula of C
H
O . It is slightly soluble in ethanol
(7.01 mg/g at 25 C) and insoluble in water. Panretin gel is a clear,
yellow gel containing
0.1% (w/w) alitretinoin in a base of dehydrated alcohol USP,
polyethylene glycol 400 NF,
hydroxypropyl cellulose NF, and butylated hydroxytoluene NF.
CLINICAL PHARMACOLOGY
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.
PHARMACOKINETICS
No studies have examined plasma 9-_cis_-retinoic acid concentrations
before and after
treatment with Panretin gel. There is, however, indirect evidence that
absorption is not
extensive. Plasma concentrations of 9-_cis_-retinoic acid were
evaluated during clinical
studies in patients with cutaneous lesions of AIDS-related KS after
repeated multiple-daily
®
20
28
2
o
®
®
studies in patients with cutaneous lesions of AIDS-related KS after
repeated multiple-daily
dose application of Panretin gel for up to 60 weeks. The range of
9-_cis_-retinoic acid
plasma concentrations in these patients was similar to the range of
circulating, naturally-
occurring 9-_cis_-retinoic acid plasma concentrations in untreated
healthy volunteers.
Although the