Tretinoin Compassionate Use and Expanded Access: How to Get Tretinoin Cheaper

Does tretinoin qualify for compassionate use?

Expanded access is not needed because approved topical tretinoin is already available by prescription. Retin-A cream and gel are indicated for acne vulgaris. Retin-A Micro is indicated for acne vulgaris in patients 12 years and older. Renova (tretinoin cream) 0.02% is indicated as an adjunct, alongside a comprehensive skin care and sunlight avoidance program, for mitigation (palliation) of fine facial wrinkles [1].

What does the Renova label cover?

The Renova label states that it does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging or restore more youthful skin [1]. It also says that safety and efficacy of daily use beyond 52 weeks have not been established [1]. The label says the product should not be used if the patient is pregnant or attempting to become pregnant [1].

How does compounded tretinoin differ from approved products?

Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before marketing. FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug [2]. A generic drug is approved under section 505(j) of the Food, Drug and Cosmetic Act and must establish therapeutic equivalence to the brand-name drug; a compounded drug is not approved [2].

What does the Renova label say to watch for?

The label warns that exposure to sunlight, including sunlamps, should be avoided or minimized because of heightened sunburn susceptibility, and it recommends sunscreens of at least SPF 15 and protective clothing [1]. The label says patients with sunburn should not use Renova until fully recovered, and that it should not be administered to patients taking known photosensitizers such as thiazides, tetracyclines, fluoroquinolones, phenothiazines or sulfonamides [1].

Local irritation is the main side effect. In double-blind vehicle-controlled studies of 339 patients, almost all reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema and pruritus. In 32% of patients, irritation was severe, led to temporary discontinuation or led to use of a mild topical corticosteroid, and about 4% discontinued because of adverse reactions [1].