Sofdra (sofpironium bromide)

Dosage of sofpironium bromide is expressed in terms of sofpironium.

Administer sofpironium topically. Sofpironium bromide is available as a topical gel that contains 12.45% of sofpironium in a 50 mL bottle with a metered pump; each full pump delivers 72 mg in 0.67 mL of gel.

Apply sofpironium gel to clean, dry, unshaven underarms (do not shave within 8 hours or shower within 30 minutes prior). Dispense one pump onto the supplied applicator and apply to one underarm, spreading to cover entire underarm area; repeat with a separate pump for the other underarm. Allow to dry for 5 minutes before dressing. Wash hands with soap immediately after use. Do not touch underarms after applying. Do not wash or shower for at least 8 hours after application. Do not apply to broken skin or use with occlusive dressings. Avoid contact with the eyes and avoid fires, flames, or smoking during and shortly after application.

Store sofpironium gel upright at 20-25degreesC (excursions permitted between 15-30degreesC). Keep away from heat or flame, as the product is flammable.

No dosing information is available for this tab.

Sofpironium is metabolized by cytochrome P-450 (CYP) 2D6 and CYP3A4. The drug inhibits CYP2D6, CYP3A4, organic cation transporter (OCT)1 and OCT2, and multidrug and toxin extrusion protein (MATE)1, but does not induce CYP1A2, CYP2B6, or CYP3A4.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Sofpironium/Strong Cyp2d6 Inhibitors

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Strong inhibitors of CYP2D6 may inhibit the metabolism of sofpironium.(1)

CLINICAL EFFECTS: Concurrent use of strong CYP2D6 inhibitors may result in elevated levels and adverse effects of sofpironium, including increased risk of anticholinergic side effects.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The concurrent use of sofpironium and strong CYP2D6 inhibitors should be avoided.(1) If concurrent therapy is warranted with a strong CYP2D6 inhibitor, monitor patients closely for anticholinergic side effects.

DISCUSSION: In a drug interaction study in healthy subjects, coadministration of paroxetine (a strong CYP2D6 inhibitor) with sofpironium increased the maximum concentration (Cmax) and area-under-the-curve (AUC) by approximately 2-fold compared to sofpironium administration alone.(1) Strong CYP2D6 inhibitors linked to this monograph include bupropion, dacomitinib, fluoxetine, paroxetine, quinidine, and terbinafine.(2,3)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Patients with conditions worsened by anticholinergic effects, such as glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe or complicating ulcerative colitis, toxic megacolon, myasthenia gravis, and Sjogren's syndrome.

• Glaucoma
• Myasthenia gravis
• Paralytic ileus
• Shock
• Sjogren's syndrome
• Toxic megacolon

• Benign prostatic hyperplasia
• Ulcerative colitis
• Urinary retention

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >=2%) reported with sofpironium gel in clinical studies were dry mouth, blurred vision, mydriasis, urinary retention, and application site pain, erythema, dermatitis pruritus, and irritation.

There are no severe adverse reactions for this drug.

More Frequent

• Acute pain at drug application site
• Blurred vision
• Dermatitis due to topical drug
• Erythema
• Mydriasis
• Skin irritation
• Urinary retention
• Xerostomia

Less Frequent

• Dry eye
• Dry skin
• Exfoliative dermatitis
• Folliculitis
• Headache disorder
• Hypertension
• Influenza
• Pain
• Pruritus of skin
• Skin rash
• Upper respiratory infection

No enhanced messaging available.

The safety, effectiveness, and pharmacokinetics of sofpironium have been established in pediatric patients >=9 years of age, based on data from 2 randomized controlled trials and 2 long-term, open-label studies involving 72 children.

There are no human data on sofpironium use in pregnancy; animal studies showed no adverse effects at doses 10-31 times the maximum recommended human dose, but the risk of birth defects or miscarriage in humans remains unknown.

There are no data on sofpironium in human milk or its effects on infants or milk production. Administration of a subcutaneous dose of sofpironium to lactating rats resulted in detectable drug levels in their milk. The benefits of breastfeeding should be weighed against the mother's clinical need and potential risks.

Clinical trials of sofpironium included too few patients >=65 years of age to assess age-related differences, though no differences have been reported; dosing in elderly patients should be cautious due to potential declines in organ function, presence of comorbidities, and use of concurrent therapies.