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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Embryo-Fetal Toxicity : Can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception. ( 5.1 . 8.1 , 8.3 ) • Photosensitivity : Minimize exposure to sunlight and sunlamps. ( 5.2 ) • DEET toxicity : Do not use DEET-containing products ( 5.3 ) 5.1 Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, PANRETIN GEL can cause fetal harm when administered to a pregnant woman. Oral administration of alitretinoin to pregnant animals during the period of organogenesis was teratogenic and embryo-lethal at exposures 5 times the estimated daily human topical dose. Advise women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during treatment with PANRETIN GEL and for 1 week after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] . 5.2 Photosensitivity Retinoids as a class have been associated with photosensitivity. Advise patients to minimize exposure of treated areas to sunlight and sunlamps during the use of PANRETIN GEL. 5.3 Toxicity with DEET-Containing Products Animal toxicology studies showed increased DEET toxicity when DEET was included as part of the formulation. Advise patients to not use PANRETIN GEL concurrently with products that contain DEET (N,N-diethyl-m-toluamide), a common component of insect repellent products.
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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PANRETIN GEL was assessed in two multicenter, prospective, randomized, double-blind, vehicle-controlled trials (Trial 1 and Trial 2) in patients with cutaneous lesions of AIDS-related KS [see Clinical Studies ( 14.1 )] . In a pooled analysis of both trials, the most common adverse reactions in ≥ 5% of patients were rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorder. In Trial 1, severe local skin adverse reactions (erythema and edema with or without vesiculation) occurred in 10% of patients during the first 12 weeks of treatment (versus 0% in the vehicle control). Adverse reactions led to withdrawal from the study in 7% of patients. In Trial 2, severe local skin adverse reactions (erythema and edema with or without vesiculation) occurred in 6% of patients during the first 12 weeks of treatment (versus 0% in the vehicle control) and 1 patient withdrew due to severe skin irritation. Table 1 lists the most common application site adverse reactions that occurred in a least 5% of patients during the double-blind phase who received PANRETIN GEL in either of the two controlled studies. TABLE 1: Adverse Reactions at Application Site in Trial 1 and 2 in ≥ 5% of Patients Treated with PANRETIN GEL A dverse Event Term Trial 1 Trial 2 PANRETIN GEL N=134 % Vehicle Gel N=134 % PANRETIN GEL N=36 % Vehicle Gel N=46 % Rash 1 77 11 25 4 Pain 2 34 7 0 4 Pruritus 3 11 4 8 4 Exfoliative dermatitis 4 9 2 3 0 Skin disorder 5 8 1 0 0 Edema 6 8 3 3 0 Parethesia 7 3 0 22 7 Includes Investigator terms: 1 Erythema, scaling, irritation, redness, rash, dermatitis 2 Burning, pain 3 Itching, pruritus 4 Flaking, peeling, desquamation, exfoliation 5 Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing 6 Edema, swelling, inflammation 7 Stinging, tingling