Glycopyrronium tosylate was not carcinogenic when topically applied to rats daily for up to 24 months in solution at concentrations of 1%, 2%, and 4% w/w.
When glycopyrrolate was administered via oral gavage to mice for up to 24 months at dosages of 2.5, 7, and 20 mg/kg/day in both genders, no significant changes in tumor incidence were observed when compared to control.
When glycopyrrolate was administered via oral gavage to rats for up to 24 months at dosages of 5, 15, and 40 mg/kg/day in both genders, no significant changes in tumor incidence were observed when compared to control.
Glycopyrrolate was negative in a battery of genetic toxicology studies that included a bacterial reverse mutation (Ames) assay, a mouse lymphoma assay conducted with L5178Y/TK+/- cells, and an in vivo micronucleus assay with mice. Glycopyrronium tosylate was negative in an Ames assay.
Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage. No treatment-related effects on fertility or reproductive parameters were observed in either gender.
Two randomized, vehicle-controlled multicenter trials, Trial 1 (NCT02530281) and Trial 2 (NCT02530294), were conducted in subjects with primary axillary hyperhidrosis and enrolled a total of 697 subjects 9 years of age or older. Inclusion criteria required that prior to the start of treatment, all subjects produce at least 50 mg of sweat in each axilla over a 5-minute period and rate the severity of their sweating daily over a week with a mean score of 4 or higher on the ASDD item #2, a patient reported outcome instrument scored from 0 (no sweating) to 10 (worst possible sweating). The median sweat production over 5 minutes at baseline was 122 mg in the Qbrexza arm and 113 mg in the vehicle arm in Trial 1, and 127 mg in the Qbrexza arm and 117 mg in the vehicle arm in Trial 2. The average weekly mean score on the ASDD item #2 at baseline was approximately 7.2 across both trials.
Subjects were randomized to receive either Qbrexza or vehicle applied once daily to each axilla. The co-primary endpoints were the proportion of subjects having at least a 4-point improvement from baseline in the weekly mean ASDD item #2 score at Week 4 and the mean absolute change from baseline in gravimetrically measured sweat production at Week 4.
The results of Trial 1 and Trial 2 are presented in Table 5 below.
|Trial 1||Trial 2|
|Qbrexza, 2.4% N = 229||Vehicle N = 115||Qbrexza 2.4% N = 234||Vehicle N = 119|
|ASDD Item #2 Response at Week 4:|
|Proportion of subjects with at least a 4-point improvement from baseline in the weekly mean ASDD item #2 at Week 4||53%||28%||66%||27%|
|Change from Baseline in Sweat Production at Week 4 (mg/5 minutes):|
|25th percentile, 75th percentile||-149, -40||-106, -28||-144, -45||-122, -21|
Qbrexza is supplied as:
A single-use cloth pre-moistened with a 2.4% glycopyrronium solution in a pouch
Carton of 30 pouches NDC 70428-011-12
Store at room temperature 20° — 25°C (68° — 77°F); excursions permitted to 15° — 30°C (59° — 86°F) [See USP Controlled Room Temperature].
Qbrexza is flammable; keep away from heat or flame.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Worsening of Urinary Retention
Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder). Instruct patients to discontinue use and consult a physician immediately should any of these signs or symptoms develop.
Control of Body Temperature (Risk of Overheating or Heat Illness)
In the presence of high ambient temperature, heat illness 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 Qbrexza. If this occurs, instruct patients to contact their healthcare provider, discontinue use of Qbrexza and avoid operating a motor vehicle or other machinery, or performing hazardous work until symptoms resolve.
Instructions for Administering Qbrexza
It is important for patients to understand how to correctly apply Qbrexza (see Patient Information).
- Instruct patients to use one cloth to apply Qbrexza to both axillae by wiping the cloth across one underarm, ONE TIME.
- Using the same cloth, apply the medication to the other underarm, ONE TIME.
- Inform patients that Qbrexza can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
- Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
- Remind patients not to apply Qbrexza to other body areas or to broken skin. Instruct patients to avoid using Qbrexza with occlusive dressings.
- Qbrexza is flammable; avoid use near heat or flame.
Dermira, Inc. Menlo Park, CA 94025
Version 1, June 2018
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Revised: 06/2018|
Qbrexza™ (kew brex’ zah) (glycopyrronium) cloth, 2.4%
Important Information: Qbrexza is for use on the skin in the underarm area only.
What is Qbrexza?
Qbrexza is a prescription anticholinergic medicine used on the skin (topical) to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older.
It is not known if Qbrexza is safe and effective in children under 9 years of age.
Who should not use Qbrexza?
Do not use Qbrexza if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as glaucoma, severe ulcerative colitis or certain other serious bowel problems associated with severe ulcerative colitis, myasthenia gravis, and Sjogren’s syndrome.
Talk to your healthcare provider if you are not sure if you have a medical condition that can be made worse by taking an anticholinergic medicine.
Before using Qbrexza, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Qbrexza may affect the way other medicines work causing side effects. Especially tell your healthcare provider if you take anticholinergic medicines.
Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use Qbrexza?
What should I avoid while using Qbrexza?
What are the possible side effects of Qbrexza?
Qbrexza can cause serious side effects, including:
These are not all of the possible side effects of Qbrexza.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
How should I store Qbrexza?
Keep Qbrexza and all medicines out of the reach of children.
General information about the safe and effective use of Qbrexza.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Qbrexza for a condition for which it was not prescribed. Do not give Qbrexza to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Qbrexza that is written for health professionals.
What are the ingredients in Qbrexza?
Active Ingredient: glycopyrronium tosylate
Inactive Ingredients: citric acid, dehydrated alcohol, purified water, and sodium citrate
Manufactured for: Dermira, Inc. Menlo Park, California 94025
For more information, go to www.Qbrexza.com or call 1-877-337-5553.
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