Sofpironium Bromide (Monograph)

Brand name: Sofdra™
Drug class: Astringents

Medically reviewed by Drugs.com on Nov 10, 2024. Written by ASHP.

Introduction

Sofpironium bromide, a competitive inhibitor of acetylcholine, is an anticholinergic drug.

Uses for Sofpironium Bromide

Sofpironium bromide has the following uses:

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

Sofpironium Bromide Dosage and Administration

General

Sofpironium bromide is available in the following dosage form(s) and strength(s):

Topical gel: 12.45% (w/w) of sofpironium in a 50 mL bottle with a metered dose pump and applicator. One full pump delivers 72 mg sofpironium in 0.67 mL of gel.

Administration

• For topical use only.

• Do not shave armpits at least 8 hours before applying sofpironium.

• Do not shower at least 30 minutes before applying sofpironium.

• 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 sofpironium.

• Avoid transfer of sofpironium to the periocular area.

• Do not apply sofpironium to broken skin.

• Avoid using sofpironium with occlusive dressings.

Dosage

• Apply sofpironium topical gel 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 a separate, single pump actuation to the top of the supplied applicator. Apply the entire amount to the second underarm. Allow to dry completely (5 minutes) before putting on clothing.

• Wash hands immediately with soap.

• Do not use more than once daily.

Cautions for Sofpironium Bromide

Contraindications

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

Warnings/Precautions

Warnings

Urinary Retention

Use sofpironium with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Discontinue use immediately and consult a healthcare provider should any of these signs or symptoms develop.

Control of Body Temperature

In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs, including sofpironium. Watch for generalized lack of sweating when in hot or very warm environmental temperatures and avoid using sofpironium topical gel if not sweating under these conditions.

Operating Machinery or an Automobile

Transient blurred vision may occur with use of sofpironium. If blurred vision occurs, discontinue use and avoid engaging in activities that require clear vision, such as operating a motor vehicle or other machinery or performing hazardous work, until the symptoms have resolved.

Specific Populations

Pregnancy

There are no available data with sofpironium 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 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).

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.

Lactation

There are no data on the presence of sofpironium or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sofpironium and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Sofpironium was detected in milk following single subcutaneous administration to lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

Pediatric Use

The safety, effectiveness, and pharmacokinetics of sofpironium for the treatment of primary axillary hyperhidrosis have been established in pediatric patients 9 years of age and older. Use of sofpironium 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 sofpironium have not been established in pediatric patients younger than 9 years of age.

Geriatric Use

Clinical trials of sofpironium did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Hepatic Impairment

The safety and effectiveness of sofpironium in populations with hepatic impairment have not been established.

Renal Impairment

The safety and effectiveness of sofpironium in populations with renal impairment have not been established.

Common Adverse Effects

Most common adverse reactions (incidence ≥2%) are dry mouth, vision blurred, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, and application site irritation.

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Anticholinergics

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

Strong Inhibitors of CYP2D6

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

Actions

Mechanism of Action

Sofpironium is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. The drug indirectly reduces the rate of sweating by preventing the stimulation of these receptors.

Advice to Patients

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

• Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder). Instruct patients to discontinue use and consult a healthcare provider immediately should any of these signs or symptoms develop.

• Advise patients that in the presence of high ambient temperature, heat illness due to decreased sweating can occur with the use of sofpironium. Advise patients to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid using sofpironium if not sweating under these conditions.

• Advise patients that transient blurred vision may occur with sofpironium. If this occurs, instruct patients to contact their healthcare provider, discontinue use of sofpironium, and avoid operating a motor vehicle or other machinery or performing hazardous work until symptoms resolve.

• Advise patients to not shave armpits at least 8 hours before applying sofpironium.

• Advise patients to not shower at least 30 minutes before applying sofpironium.

• Advise patients to apply 1 pump actuation per underarm to clean, dry skin once a day at bedtime (total 2 pumps). Allow to dry completely (5 minutes) before putting on clothing.

• Advise patients to wait at least 8 hours after applying the gel to shower or wash underarms.

• Advise patients to not use sofpironium more frequently than once daily.

• Instruct patients to wash their hands with soap and water immediately after applying sofpironium.

• Instruct patients not to apply sofpironium to other body areas or to broken skin and to avoid using the topical gel with occlusive dressings.

• Advise patients that sofpironium is flammable; avoid fire, flame, and smoking during and immediately following application.

Additional Information

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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