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Sofdra healthcare professionals homepage

Novel Sofdra MOA

Sofdra is a novel
topical agent created to block M3 receptors in sweat glands1,2

Prescribe Sofdra exclusively through SendRx
—commercially insured patients pay $0*

M3 is the receptor primarily involved in eccrine sweat gland signaling3,4

Silhouette of body in blue with underarm area highlighted in yellow. Inset of underarm shows eccrine sweat cell with unactivated M3 receptor.
In addition to eccrine gland cells, M3 receptors are also found in smooth muscle structures (e.g., pupils, bladder, bronchi).4-7

Dysregulated muscarinic signaling in an untreated eccrine sweat gland

Eccrine sweat gland within epidermis surrounded by acetylcholine and SOFDRA molecules. Inset of sweat gland show acetylcholine molecules binding to M3 receptors.
In primary axillary hyperhidrosis, sweat glands are overstimulated by acetylcholine binding to M3 receptors, triggering excessive sweat.3-7

Targeted M3 inhibition in a sweat gland treated with Sofdra

Eccrine sweat gland within epidermis surrounded by acetylcholine and SOFDRA molecules. Inset of sweat gland shows M3 receptors activated by either binding acetylcholine or blocked by binding SOFDRA molecules.
Sofdra selectively binds to and blocks M3 sweat gland receptors to reduce sweat at the source.1,2
Sofdra is designed for simple axillary application.1,8
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*Terms and Conditions apply.

Indication

Sofdra™ (sofpironium) topical gel, 12.45% is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications

Sofdra is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Sofdra (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

Urinary retention

Use Sofdra with caution in patients with a history or presence of documented urinary retention. Patients should discontinue use immediately and consult a healthcare provider should any signs or symptoms of urinary retention develop (e.g., difficulty passing urine, distended bladder).

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 Sofdra. Patients should avoid using Sofdra if not sweating when in hot or very warm environmental temperatures.

Operating Machinery or an Automobile

Transient blurred vision may occur with Sofdra. If blurred vision occurs, discontinue use and avoid engaging in activities that require clear vision (e.g., operating a motor vehicle or machinery, performing hazardous work) until the symptoms have resolved.

Adverse Reactions

The most common adverse reactions (≥2%) are dry mouth, vision blurred, mydriasis, and urinary retention. The most common local skin reactions (≥2%) are pain, erythema, dermatitis, pruritus, irritation, and exfoliation.

Drug Interactions

Avoid coadministration of Sofdra with other anticholinergic medications (due to risk of increase in anticholinergic adverse effects) and drugs that are strong inhibitors of CYP2D6.

Please see full Prescribing Information.

References: 1. Sofdra™ (sofpironium) topical gel, 12.45%. Prescribing Information. Wayne, PA: Botanix SB Inc. 2. Fujimoto T, Abe Y, Igarashi M, et al. A phase III, 52-week, open-label study to evaluate the safety and efficacy of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis. J Dermatol. 2021;48(9):1149–1161. doi:10.1111/1346-8138.15927 3. Brackenrich J, Fagg C. Hyperhidrosis. NCBI Bookshelf. October 3, 2022. Accessed November 24, 2024. ncbi.nlm.nih.gov/books/NBK459227 4. Cui C, David S. Eccrine sweat gland development and sweat secretion. Exp Dermatol. 2015;24(8):644–650. doi:10.1111/exd.12773 5. Brown J, Brandl K, Wess J. Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. 14th ed. McGraw Hill. 2024. 6. Tolaymat M, Larabee S, Hu S, Xie G, Raufman JP. The role of M3 muscarinic receptor ligand-induced kinase signaling in the colon cancer progression. Cancers. 2019;11(3):308. doi:10.3390/cancers11030308 7. Broadley K, Kelly D. Muscarinic receptor agonists and antagonists. Molecules. 2001; 6(3):142–193. doi:10.3390/60300142 8. Sofdra™ (sofpironium) topical gel, 12.45%. Instructions for Use. Wayne, PA: Botanix SB Inc.
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