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Primary Axillary Hyperhidrosis

~10 million patients in the US have primary axillary hyperhidrosis and many still struggle to stay dry1-3

The condition leaves patients with more than just visible sweat stains—it causes distress that impacts their self-esteem2,4

  • 69% reported experiencing constant worry about noticeable sweating4*
  • >70% reported that excessive sweating has had negative impact on their social life2†

Excessive sweating can look different for different patients

In a survey, the majority of patients report difficulties interacting with others due to excessive sweating.4†
*
Based on a study with 71 participants recruited from hyperhidrosis support groups.4
Based on an online survey, where 8,160 people provided information as to whether or not they experience hyperhidrosis.2

Failing to stay dry leads patients to resort to several coping mechanisms that often fail to manage their excessive sweat and disrupt their day-to-day. This can include1,3-5:

  • Frequently changing clothes or layering
  • Avoiding certain fabrics and wearing dark loose clothing
  • Bathing multiple times a day
  • Placing napkins in underarms under clothing
Patients spend a disproportionate amount of
time and effort concealing sweat.1,3

1 in 2 patients have never discussed their excessive sweating with a healthcare provider.1,2

Why? They are not aware it is a condition or they believe that nothing can be done to treat it.1,2

Sofdra is a topical treatment for primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.6
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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. Parashar K, Adlam T, Potts G. The impact of hyperhidrosis on quality of life: a review of the literature. Am J Clin Dermatol. 2023;24(2):187–198. doi:10.1007/s40257-022-00743-7 2. Doolittle J, Walker P, Mills T, Thurston J. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res. 2016;308(10):743–749. doi:10.1007/s00403-016-1697-9 3. Hamm H, Naumann M, Kowalski J, et al. Primary focal hyperhidrosis: disease characteristics and functional impairment. Dermatology. 2006;212(4):343–353 doi:10.1159/000092285 4. Kamudoni P, Mueller B, Halford J, et al. The impact of hyperhidrosis on patients' daily life and quality of life: a qualitative investigation. Health Qual Life Outcomes. 2017;15(1):121. doi:10.1186/s12955-017-0693-x 5. Sweat Clinic Australia. Navigating clothing challenges: hyperhidrosis and finding comfort. Accessed November 24, 2024. sweatclinics.au/navigating-clothing-challenges-hyperhidrosis-and-finding-comfort 6. Sofdra™ (sofpironium) topical gel, 12.45%. Prescribing Information. Wayne, PA: Botanix SB Inc.
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