Qbrexza (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

14 CLINICAL STUDIES

14.1 Efficacy and Safety Trials

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.

Clinical Response

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

Table 5: Primary Efficacy Outcomes in Subjects with Primary Axillary Hyperhidrosis
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):
Median -81 -66 -79 -58
25th percentile, 75th percentile -149, -40 -106, -28 -144, -45 -122, -21

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

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

16.2 Storage and Handling

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.

17 PATIENT COUNSELING INFORMATION

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.

Manufactured for:

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

PATIENT INFORMATION

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:

  • have prostate or bladder problems, or problems passing urine
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if Qbrexza will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Qbrexza passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Qbrexza.

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?

  • Use Qbrexza exactly as your healthcare provider tells you to use it.
  • Qbrexza comes as a single-use pre-moistened cloth in individual pouches.
  • Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only. Do not apply Qbrexza to broken skin. Do not cover the treated area with a plastic (occlusive) dressing.
  • Apply Qbrexza to both underarm areas using 1 cloth 1 time every 24 hours.

Applying Qbrexza:

  • Carefully tear open the pouch to avoid tearing the Qbrexza cloth.
  • Unfold the Qbrexza cloth and apply Qbrexza by wiping across 1 entire underarm 1 time. Using the same Qbrexza cloth, wipe across the other underarm 1 time.
  • Throw away (discard) the used Qbrexza cloth in the trash.
  • Wash your hands right away after you apply Qbrexza and have thrown away the cloth. It is important that you wash your hands because the Qbrexza that is still on your hands can cause you to have blurred vision if you touch your eyes.
  • Do not reuse the Qbrexza cloth.

What should I avoid while using Qbrexza?

  • Qbrexza may cause you to have blurred vision that is temporary. If you develop blurred vision, call your healthcare provider, stop using Qbrexza and do not drive, operate machinery, or do hazardous work until your vision is clear.
  • Qbrexza is flammable. Avoid heat and flame while applying Qbrexza to your skin

What are the possible side effects of Qbrexza?

Qbrexza can cause serious side effects, including:

  • New or worsened urinary retention. People who use Qbrexza may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:
    • difficulty urinating
    • urinating frequently
    • urination in a weak stream or drips
    • full bladder or difficulty emptying your bladder (distended bladder) If you have these symptoms, stop using Qbrexza and call your healthcare provider right away.
  • Problems with control of your body temperature. Qbrexza can cause you to have decreased sweating in areas other than the underarm area which could cause you to become overheated and to develop heat illness. When in hot or very warm temperatures, watch for lack of sweating on your body (generalized) and stop using Qbrexza if you develop lack of sweating on your body.

    Stop using Qbrexza and call your healthcare provider right away if you develop any of these symptoms of heat illness:

    • hot, red skin
    • decreased alertness or passing out (unconsciousness)
    • fast, weak pulse
    • fast, shallow breathing
    • increased body temperature (fever)
  • Blurred vision. If you develop blurred vision during treatment with Qbrexza, call your healthcare provider, stop using Qbrexza and do not drive, or operate machinery, or do hazardous work until your vision is clear.The most common side effects of Qbrexza include:
    • dry mouth
    • dilation of the pupils of your eyes (mydriasis)
    • sore throat
    • skin redness, burning/stinging or itching in underarm area
    • headache
    • problems with urination
    • blurred vision
    • nasal dryness
    • throat, eye, and skin dryness
    • constipation

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?

  • Store Qbrexza at room temperature between 68°F and 77°F (20°C and 25°C).
  • Qbrexza is flammable. Keep Qbrexza away from heat and flame.

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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