SOFPIRONIUM GEL,TOP
Clinical Criteria Summary
Indication
- Treatment of primary axillary hyperhidrosis in adults
Dosing & Administration
- Apply a single pump actuation to each armpit once daily at bedtime
- Topical gel 12.45% (w/w) supplied in a 50-mL bottle with metered dose pump and applicator
Patient Population Considerations
- Geriatric Use: Insufficient data; dosage should usually start at the low end
- Renal Impairment: Not studied
- Hepatic Impairment: Not studied
Contraindications & Warnings/Precautions
- Contraindicated in medical conditions that can be exacerbated by anticholinergic effects (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 include urinary retention, control of body temperature, and operating machinery or an automobile
- Top adverse events (≥ 2%): Dry mouth, blurred vision, mydriasis, urinary retention; Local skin reactions: Pain, erythema, dermatitis, pruritus, irritation, exfoliation
Drug Interactions
- Concomitant anticholinergics
- Strong inhibitors of CYP2D6 (avoid)
Pregnancy & Lactation
- Pregnancy: Insufficient human data; no significant embryofetal developmental adverse effects in animals; no specific recommendations about use in pregnancy
- Lactation: Insufficient human data; detected in animal milk; likely to be present in human milk; consider risks vs benefits
VA Place in Therapy / Criteria-for-Use
- Second-line (2L) treatment for primary axillary hyperhidrosis
- Indicated for patients with an inadequate response or intolerance to an aluminum chloride hexahydrate antiperspirant
- Indicated for patients for whom a prescription antiperspirant is medically inadvisable