This information is not for clinical use. These highlights do not include all the information needed to use Vaniqa safely and effectively. Before taking Vaniqa please consult with your doctor. See full prescribing information for Vaniqa.

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Contraindications

VANIQA ® is contraindicated in patients with a history of sensitivity to any components of the preparation.

Adverse Reactions

Adverse events reported for most body systems occurred at similar frequencies in VANIQA ® (eflornithine hydrochloride) cream, 13.9% and vehicle control groups. The most frequent adverse events related to treatment with VANIQA ® were skin-related. The following table notes the percentage of adverse events associated with the use of VANIQA ® or its vehicle that occurred at greater than 1% in both the vehicle-controlled studies and the open-label safety studies up to 1 year of continuous use. Adverse Event Term Vehicle-Controlled Studies Vehicle-Controlled and Open-Label Studies VANIQA® (n=393) Vehicle (n=201) VANIQA® (n=1373) Acne 21.3 21.4 10.8 Pseudofolliculitis Barbae 16.3 15.4 4.9 Stinging Skin 7.9 2.5 4.1 Headache 3.8 5.0 4.0 Burning Skin 4.3 2.0 3.5 Dry Skin 1.8 3.0 3.3 Pruritus (itching) 3.8 4.0 3.1 Erythema (redness) 1.3 0.0 2.5 Tingling Skin 3.6 1.5 2.2 Dyspepsia 2.5 2.0 1.9 Skin Irritation 1.0 1.0 1.8 Rash 2.8 0.0 1.5 Alopecia 1.5 2.5 1.3 Dizziness 1.5 1.5 1.3 Folliculitis 0.5 0.0 1.0 Hair Ingrown 0.3 2.0 0.9 Facial Edema 0.3 3.0 0.7 Anorexia 1.0 2.0 0.7 Nausea 0.5 1.0 0.7 Asthenia 0.0 1.0 0.3 Vertigo 0.3 1.0 0.1 Treatment-related skin adverse events that occurred in less than 1% of the subjects treated with VANIQA ® are: bleeding skin, cheilitis, contact dermatitis, swelling of lips, herpes simplex, numbness, and rosacea. Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of VANIQA ® . Only 2% of subjects discontinued studies due to an adverse event related to use of VANIQA ® . Laboratory Test Abnormalities No laboratory test abnormalities have been consistently found to be associated with VANIQA ® . In an open-label study, some patients showed an increase in their transaminases; however, the clinical significance of these findings is not known.

Drug Interactions

It is not known if VANIQA ® has any interaction with other topically applied drug products. Carcinogenesis, Mutagenesis and Impairment of Fertility In a 12-month photocarcinogenicity study in hairless albino mice, animals treated with the vehicle alone showed an increased incidence of skin tumors induced by exposure to ultraviolet (UVA/UVB) light, whereas mice treated topically with VANIQA ® at doses up to 600 mg/kg [19X the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA)] showed an incidence of skin tumors equivalent to untreated-control animals. A 2-year dermal carcinogenicity study in CD-1 mice treated with VANIQA ® revealed no evidence of carcinogenicity at daily doses up to 600 mg/kg (950X the MRHD based on AUC comparisons). Eflornithine did not elicit mutagenic effects in an Ames reverse-mutation assay or clastogenicity in primary human lymphocytes, with and without metabolic activation. In a dermal micronucleus assay, eflornithine hydrochloride cream, 13.9%, at doses up to 900 mg/kg (58X the MRHD based on BSA) in rats yielded no evidence of genotoxicity. In a dermal fertility and early embryonic development study in rats treated with VANIQA ® , there were no adverse reproductive effects at doses up to 450 mg/kg (29X the MRHD based on BSA). In a peri- and postnatal study in rats, eflornithine administered in the drinking water was associated with maternal toxicity and reduced pup weights at doses of at least 625 mg/kg (40X the MRHD based on BSA) and a slightly reduced fertility index, which was considered to be of questionable biological significance, at 1698 mg/kg (110X the MRHD based on BSA). No effects were seen with an oral dose of 223 mg/kg (14X the MRHD based on BSA). In the latter study, the multiples of the human exposure are likely much higher, since eflornithine is well absorbed orally in rats, whereas minimal absorption occurs in humans treated topically. Pregnancy Teratogenic Effects In the first dermal embryo-fetal development study in rats treated with eflornithine hydrochloride cream, 13.9% (in which no precautions were taken to prevent ingestion of drug from application sites), maternal toxicity and fetal effects including reduced numbers of live fetuses, decreased fetal weights, and delayed ossification and development of the viscera were observed at doses of 225 and 450 mg/kg (15X and 29X the MRHD based on BSA, respectively). When the study was repeated under conditions that avoided ingestion from application sites, no maternal, fetal or teratogenic effects were observed at doses up to 450 mg/kg (29X the MRHD based on BSA). In the first study in which no precautions were taken to prevent ingestion, circulating plasma levels were 11- to 14-fold higher than in the second study in which ingestion was prevented. In a dermal embryo-fetal development study in rabbits treated with VANIQA ® (eflornithine hydrochloride) cream, 13.9% no adverse maternal or fetal effects occurred at doses up to 90 mg/kg (11X the MRHD based on BSA). Significant dermal irritation, as well as possible ingestion of VANIQA ® occurred at 300 mg/kg/day (36X the MRHD based on BSA) and was associated with maternal deaths, abortions, increased fetal resorptions, and reduced fetal weights. Fetotoxicity in the absence of maternal toxicity has been reported in oral studies with eflornithine with fetal no-effect doses of 80 mg/kg in rats and 45 mg/kg in rabbits. In these studies, no evidence of teratogenicity was observed in rats given up to 200 mg/kg or in rabbits given up to 135 mg/kg. Although VANIQA ® was not formally studied in pregnant patients, 22 pregnancies occurred during the trials. Nineteen of these pregnancies occurred while patients were using VANIQA ® . Of the 19 pregnancies, there were 9 healthy infants, 4 spontaneous abortions, 5 induced/elective abortions, and 1 birth defect (Down's Syndrome to a 35-year-old). Because there are no adequate and well-controlled studies in pregnant women, the risk/benefit ratio of using VANIQA ® in women with unwanted facial hair who are pregnant should be weighed carefully with serious consideration for either not implementing or discontinuing use of VANIQA ® . Nursing Mothers It is not known whether or not eflornithine hydrochloride is excreted in human milk. Caution should be exercised when VANIQA ® is administered to a nursing woman. Pediatric Use The safety and effectiveness of this product have not been established in pediatric patients less than 12 years of age. Geriatric Use Of the 1373 patients on active treatment in clinical studies of VANIQA ® , approximately 7% were 65 years or older and approximately 1% were 75 or older. No apparent differences in safety were observed between older patients and younger patients.