Sofdra Drug Information

SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.

Do not shave armpits at least 8 hours before applying SOFDRA. Do not shower at least 30 minutes before applying SOFDRA. Apply SOFDRA to clean, dry skin once a day at bedtime.

Apply a single pump actuation to the top of the supplied applicator. Spread the entire amount to cover 1 underarm. Apply the entire amount to the second underarm.

Allow to dry completely (5 minutes) before putting on clothing. Wash hands immediately with soap. For topical use only.

Avoid fire, flame, and smoking during and immediately following application. Do not shower or wash underarms for at least 8 hours after application. Do not touch underarms after applying SOFDRA.

Do not use more than once daily. Avoid transfer of SOFDRA to the periocular area. Do not apply SOFDRA to broken skin.

Avoid using SOFDRA with occlusive dressings. Apply 1 pump of SOFDRA per underarm once a day at bedtime. For topical use only.

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. Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with SOFDRA.

Anticholinergics Coadministration of SOFDRA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of SOFDRA with other anticholinergic-containing drugs.

Strong Inhibitors of CYP2D6

Avoid co-administration of SOFDRA with drugs that are strong inhibitors of CYP2D6.

Pregnancy Risk Summary There are no available data with SOFDRA use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of sofpironium bromide to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 31 and 10 times, respectively, the maximum recommended human dose (MRHD) ( see Data ). The background risks of major birth defects and miscarriage for the indicated population are unknown.

All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal development study in rats, sofpironium bromide was not associated with embryofetal lethality or fetal malformations at subcutaneous dose levels of 1, 3, and 10 mg/kg/day administered during the period of organogenesis.

The maternal and fetal survival, growth and development no observed adverse effect level (NOAEL) was 10 mg/kg/day (31 times the MRHD based on AUC comparisons). In an embryofetal development study in rabbits, sofpironium bromide was administered by subcutaneous injection to pregnant rabbits at doses of 0.4, 2 and 10 mg/kg/day during the period of organogenesis. Maternal toxicity as evidenced by decreased maternal body weight gain and feed consumption was observed in all sofpironium bromide treated groups.

The decrease in maternal body weight was considered severe at 10 mg/kg/day and was associated with embryofetal lethality. The maternal toxicity NOAEL could not be established in the study. The NOAEL for embryo-fetal development toxicity was 2 mg/kg/day (10 times the MRHD based on AUC comparison).

Fetal malformation was not observed with sofpironium bromide treatment at doses up to 10 mg/kg/day (57 times the MRHD based on AUC comparison) in rabbits. Maternal toxicity associated with a 17% decrease in body weight gain noted at 6 mg/kg/day (approximately 19 times the MRHD based on AUC comparisons) when compared to the control group. No sofpironium bromide-related effects on prenatal and postnatal development, neurobehavioral or reproductive performance of offspring were noted at doses up to 6 mg/kg/day (approximately 19 times the MRHD based on AUC comparison).

Pediatric Use The safety, effectiveness, and pharmacokinetics of SOFDRA for the treatment of primary axillary hyperhidrosis have been established in pediatric patients 9 years of age and older. Use of SOFDRA in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 6-week trials and two multicenter, open-label, 24-week and 48-week trials, which included 72 pediatric subjects 9 years of age and older. The safety and effectiveness of SOFDRA have not been established in pediatric patients younger than 9 years of age.

SOFDRA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of sofpironium bromide (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren's syndrome).

In case of an overdose, remove the topically applied product with soap and water, and treat the symptoms and signs attributed to the overdose symptomatically. Consider contacting the Poison Center at 1-800-222-1222 for the latest recommendations.