Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Urinary Retention [See Warnings and Precautions (5.1) ].
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 ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Botanix SB Inc.
at 1-866-763-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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.
In two double-blind, vehicle controlled clinical trials (CARDIGAN 1 and CARDIGAN 2) of 700 subjects 10 to 76 years of age (353 subjects treated with SOFDRA and 347 subjects treated with vehicle), 44% of subjects were male, 79% were White, 21% were Black, and 1% were Asian.
A total of 618 subjects completed at least 6 weeks of treatment, including 307 subjects treated with SOFDRA and 311 subjects treated with vehicle.
Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with SOFDRA.
Table 1: Adverse Reactions Occurring in ≥2% of Subjects with Primary Axillary Hyperhidrosis Treated with SOFDRA in Trials CARDIGAN 1 and 2 Adverse Reactions SOFDRA (N = 353) n (%) Vehicle (N = 347) n (%) Note: COVID-19 was observed in 8 (2%) SOFDRA and 2 (0.6%) vehicle subjects.
Dry mouth 51 (14%) 2 (0.6%) Vision blurred 30 (9%) 1 (0.3%) Mydriasis 23 (7%) 0 Urinary retention 8 (2%) 0 Table 2 shows the local skin reactions reported ≥2%, which occurred more commonly in the SOFDRA group.
5 WARNINGS AND PRECAUTIONS Urinary Retention: Use with caution in patients with a history or presence of documented urinary retention.
Discontinue use immediately and consult a healthcare provider should any signs or symptoms of urinary retention develop ( 5.1 ).
Control of Body Temperature: Watch for generalized lack of sweating when in hot or very warm environmental temperatures and avoid using SOFDRA if not sweating under these conditions ( 5.2 ).
Operating Machinery or an Automobile: Transient blurred vision may occur with use of SOFDRA.
If blurred vision occurs, discontinue use and avoid operating a motor vehicle or other machinery until symptoms resolve ( 5.3 ).
Like all medications, Sofdra can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: