Sofpironium

Class
Anticholinergics
Subclass
Muscarinic receptor antagonists
Substance name
Sofpironium bromide
Brand names
Sofdra®
Common formulations
Gel
Dosage and administration
Adults patients
Treatment of primary axillary hyperhidrosis
•
1 pump(s) TOP qHS
Apply a single pump actuation to the top of the supplied applicator and spread the entire amount to cover one 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. Avoid showering for 8 hours after application.
Indications for use
Labeled indications
Adults
•
Treatment of primary axillary hyperhidrosis
Safety risks
Contraindications
Hypersensitivity to sofpironium or its components
Conditions that can worsen with anticholinergic agents
•
Do not use sofpironium in patients with medical conditions that can be exacerbated by the anticholinergic effect of sofpironium, such as glaucoma, paralytic ileus, unstable cardiovascular status in acute bleeding, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, and Sjögren's syndrome.
Concomitant use of other anticholinergic agents
Concomitant use of potent CYP2D6 inhibitors
Warnings and precautions
Blurred vision
•
Maintain a high level of suspicion, as sofpironium may cause transient blurred vision. Discontinue use if blurred vision occurs and avoid performing activities requiring clear vision, such as driving or operating machinery until symptoms resolve.
Exacerbation of urinary retention
•
Use caution in patients with a history or presence of urinary retention.
Increased body temperature
•
Maintain a high level of suspicion, as anticholinergic drugs can cause heat illness in high ambient temperatures. Monitor for a general lack of sweating in hot or very warm environmental temperatures, and avoid using sofpironium if sweating does not occur under these conditions.
Specific populations
Renal impairment
CrCl 0-90 mL/min
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Insufficient evidence.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Application site reactions, blurred vision, dry mouth, pain, pruritus
Common 1-10%
•
Dermatitis, folliculitis, hypertension, influenza, mydriasis, skin irritation, skin rash, dry eyes, urinary retention, skin dryness, headache, skin erythema, skin exfoliation, upper respiratory tract infections
Interactions
Drug(s)
Check Interactions
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