Get your patient on Sofdra - Sofpironium Bromide gel (Sofpironium Bromide)

SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.

• Do not shave armpits at least 8 hours before applying SOFDRA.
• Do not shower at least 30 minutes before applying SOFDRA.
• Apply SOFDRA to clean, dry skin once a day at bedtime.
• Apply a single pump actuation to the top of the supplied applicator. Spread the entire amount to cover 1 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.
• Wash hands immediately with soap.
• For topical use only.
• Avoid fire, flame, and smoking during and immediately following application.
• Do not shower or wash underarms for at least 8 hours after application.
• Do not touch underarms after applying SOFDRA.
• Do not use more than once daily.
• Avoid transfer of SOFDRA to the periocular area [see Warnings and Precautions (5.3) ] .
• Do not apply SOFDRA to broken skin.
• Avoid using SOFDRA with occlusive dressings.

Topical gel: 12.45% (w/w) of sofpironium in a 50 mL bottle with a metered dose pump and applicator. One full pump delivers 72 mg sofpironium in 0.67 mL of gel.

SOFDRA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of sofpironium bromide (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren's syndrome).

• 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 ).

The following clinically significant adverse reactions are described elsewhere in the labeling:

Urinary Retention [See Warnings and Precautions (5.1) ].

• Anticholinergics: Coadministration of SOFDRA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of SOFDRA with other anticholinergic-containing drugs (7.1 ).
• Strong Inhibitors of CYP2D6: Avoid co-administration of SOFDRA with drugs that are strong inhibitors of CYP2D6 (7.2 ).

SOFDRA (sofpironium) topical gel is an anticholinergic drug. Sofpironium bromide drug substance is a white to off white powder with the chemical name 3'(R)-[2(R) cyclopentylphenylhydroxy-acetoxy]-1'-methyl-1'-ethoxycarbonylmethyl-pyrrolidinium bromide, very soluble in chloroform and freely soluble in water, ethanol, acetonitrile, and methanol, molecular formula of C ₂₂ H ₃₂ BrNO ₅ , molecular weight of 470.4 g/mol, and the following structural formula:

SOFDRA is a clear to translucent, colorless to pale yellow viscous gel containing 12.45% (w/w) sofpironium (equivalent to 15% sofpironium bromide) in an airless bottle sealed with a multi-dose metered pump. Each pump delivers 72 mg of sofpironium (equivalent to 87 mg of sofpironium bromide) in 0.67 mL of gel. The inactive ingredients are citric acid, 77.2% v/v dehydrated alcohol, hexylene glycol, hydroxypropyl cellulose, and isopropyl myristate.

Two randomized, vehicle-controlled multicenter trials, CARDIGAN 1 (NCT03836287) and CARDIGAN 2 (NCT03948646), enrolled a total of 701 subjects 10 years of age or older with primary axillary hyperhidrosis. All subjects were to have symptoms of axillary hyperhidrosis for at least 6 months' duration, produce at least 50 mg of sweat in each axilla (underarm) with a combined total of at least 150 mg over a 5-minute period, and have a Hyperhidrosis Disease Severity Measure-Axillary, 7-item scale score (HDSM-Ax-7) ≥3.

In the trials, 56% of subjects were female, 78% were White, and 20% were Black or African American; for ethnicity, 31% identified as Hispanic or Latino. Fewer than 1% of subjects were less than 12 years of age, 7% were 12 to 17 years of age, 91% were 18 to 64 years of age, and 1% were 65 years of age or older.

Subjects 12 years of age and older were asked to rate their underarm sweating severity and frequency since waking on the previous day ("since you woke up yesterday") on the 11-item HDSM-Ax Adult version instrument. The HDSM-Ax-7 scale score was calculated by taking an average of 7 items, where the scale score ranges from 0 to 4 with a higher score representing greater underarm sweating severity. The mean HDSM-Ax-7 scale score at Baseline was 3.5 in CARDIGAN 1, and 3.6 in CARDIGAN 2. The median gravimetric sweat production (GSP) over 5 minutes at Baseline was 214.1 mg in the SOFDRA arm and 228.6 mg in the vehicle arm in CARDIGAN 1, and 207.7 mg in the SOFDRA arm and 231.1 mg in the vehicle arm in CARDIGAN 2.

Subjects were randomized to receive either SOFDRA or vehicle applied once daily at bedtime to each axilla. The co-primary endpoints were the proportion of subjects having at least a 2-point improvement in the HDSM-Ax-7 scale score from Baseline to Day 43, and the change in GSP from Baseline to Day 43.

The results of CARDIGAN 1 and CARDIGAN 2 are presented in Table 5.

SOFDRA™
(sof-drah)
(sofpironium)
topical gel, 12.45%

These Instructions for Use contain information on how to use SOFDRA.

Read the Instructions for Use before you start using SOFDRA and each time you get a refill.

This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

If you have questions, ask your pharmacist or healthcare provider.

SOFDRA Parts

Prepare to Apply SOFDRA

1 Check if you are ready to apply SOFDRA

1.1 Apply SOFDRA before bedtime (Figure B).

1.2 Before applying SOFDRA make sure that you:

2 Gather supplies

2.1 Gather the following supplies.

• SOFDRA (Figure C)
  
• Clean towel (Figure D)

3 Check the expiration date

3.1 Check the expiration date ("EXP") on the Bottle label to make sure it has not passed (Figure E).

4 Remove Blue Cap and Applicator from Bottle

4.1 Pull the Blue Cap straight off the Bottle and set it aside (Figure F).

4.2 Pull the gel Applicator straight off the Bottle and set it aside (Figure G).

5 Prime the pump (First time use only)

Important: Priming the pump is required the first time you use a new Bottle. The purpose of priming is to make sure the pump works correctly and dispenses gel properly.
5.1 Hold the Bottle over a sink. Press the pump all the way down 1 to 2 times, or until you see gel coming out (Figure H).
5.2 Use water to wash down any gel in the sink (Figure I).
Do not touch or use any of the gel residue from the sink.

6 Prepare underarms

Apply 1 Pump of SOFDRA to Each Armpit

7 Apply 1 pump of SOFDRA gel to first underarm

8 Apply 1 pump of SOFDRA gel to second underarm

9 Let SOFDRA gel dry

9.1 Let SOFDRA gel dry for 5 minutes after it is applied (Figure P). Keep clothing off the area while it dries.
Note: It is okay to put your arms down.

What to do After Applying SOFDRA

10 Rinse and dry Applicator

10.1 Rinse off the Applicator with water (Figure Q).
Avoid touching the gel with your hands or fingers.

10.2 Pat the Applicator dry (Figure R).

11 Wash hands

11.1 Always wash your hands with soap and water right away after applying SOFDRA gel to avoid spreading any gel residue to any other parts of your body (Figure S).

12 Reassemble and store SOFDRA after use

13 Keep SOFDRA on skin for at least 8 hours

13.1 Wait at least 8 hours after applying SOFDRA before you shower or wash your underarms (Figure W).

Do not shower or wash your underarms for at least 8 hours after applying SOFDRA.

Storage Information
Store SOFDRA upright at room temperature between 68°F to 77°F (20°C to 25°C) (Figure X)
Keep SOFDRA and all medicines out of reach of children.

Disposal Information
After applying 30 daily doses of SOFDRA gel (Figure Y), throw away the Blue Cap, Applicator, and Bottle into the household trash.

Sofpironium bromide is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. Sofpironium bromide indirectly reduces the rate of sweating by preventing the stimulation of these receptors.