Qbrexza

Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.

For topical use only.

Qbrexza is for topical use in the underarm area only and not for use in other body areas.

Qbrexza is administered by a single-use pre-moistened cloth packaged in individual pouches. Qbrexza should be applied to clean dry skin on the underarm areas only. Qbrexza should not be used more frequently than once every 24 hours.

Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply Qbrexza to both underarms.

After applying Qbrexza, discard the cloth in the household trash out of reach of children and others. Wash hands immediately with soap and water after applying and discarding the Qbrexza cloth. Qbrexza may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of Qbrexza to the periocular area

Do not apply Qbrexza to broken skin. Avoid using Qbrexza with occlusive dressings.

Cloth: A single-use cloth pre-moistened with 2.4% glycopyrronium solution

• Pediatric use: Safety and efficacy are not established in patients under 9 years of age (
  8.4 Pediatric Use

  The safety, effectiveness and pharmacokinetics of Qbrexza have been established in pediatric patients age 9 years and older for topical treatment of primary axillary hyperhidrosis

  [see Clinical Pharmacology ]

  . Use of Qbrexza in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older

  [see Adverse Reactions and Clinical Studies ]

  . The safety and effectiveness of Qbrexza have not been established in pediatric patients under 9 years of age.
  ).

• New or worsening urinary retention: Use with caution in patients with a history of documented urinary retention (
  5.1 New or Worsening Urinary Retention

  New or worsening signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder) have occurred in patients taking Qbrexza with or without a history of documented urinary retention. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop.

  Qbrexza should be used with caution in patients with prostatic hypertrophy or bladder-neck obstruction.
  ).
• Control of body temperature: In the presence of high ambient temperature, heat illness may occur; avoid use if patients develop generalized lack of sweating when exposed to hot or very warm environmental temperatures (
  5.2 Control of Body Temperature

  In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Qbrexza. Advise patients using Qbrexza to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
  ).
• Operating machinery or an automobile: Transient blurred vision may occur with use of Qbrexza. If blurred vision occurs, discontinue use of Qbrexza until symptoms resolve; avoid operating a motor vehicle or other machinery until symptoms resolve (
  5.3 Operating Machinery or an Automobile

  Transient blurred vision may occur with use of Qbrexza. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
  ).