Primary axillary hyperhidrosis, also known as excessive underarm sweating, is a medical condition defined by excessive, uncontrollable underarm sweating that goes well beyond what the body needs for normal temperature regulation. It is the most prevalent form of primary hyperhidrosis, affecting an estimated 15.3 million people in the United States and it typically begins in adolescence or early adulthood, often before age 25. Unlike secondary hyperhidrosis, which is caused by an underlying medical condition or medication, primary hyperhidrosis has no identifiable external cause. The condition is bilateral (affecting both underarms), tends to occur during waking hours, happens at least once a week, and frequently runs in families, with 35% to 56% of patients reporting a family history of excessive sweating.1,2
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QBREXZA (glycopyrronium) cloth, 2.4%, is a prescription medication used on the skin to treat excessive underarm sweating (primary axillary hyperhidrosis) in people 9 years of age and older.
QBREXZA is for use on the skin in the underarm only. Wash your hands right away after you apply QBREXZA and have thrown away the cloth in the trash out of the reach of children and others.
What is the most important information I should know about QBREXZA?
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 (UC) or certain other serious bowel problems associated with UC, myasthenia gravis, and Sjogren’s syndrome.
What should I tell my healthcare provider before using QBREXZA?
Tell your healthcare provider about all your medical conditions, including if you have prostate, bladder or kidney problems or problems passing urine; if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. It is not known if QBREXZA will harm your unborn baby or pass into breastmilk.
Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines and especially any anticholinergic medicines.
What are the possible side effects of QBREXZA?
Serious side effects may include:
New or worsened urinary retention: People who use QBREXZA may develop new or worse urinary retention. Urinary retention can result from a blockage in your bladder or a larger than normal prostate. Stop using QBREXZA and call your healthcare provider right away if you experience any of the following symptoms: difficulty urinating; urinating frequently; urinating in a weak stream or drips; full bladder or difficulty emptying your bladder.
Problems with control of your body temperature: QBREXZA can cause you to have decreased sweating in areas other than the underarm leading to overheating and the development of heat illness when in hot or very warm temperatures. Stop using QBREXZA and call your healthcare provider right away if you experience any of the following symptoms: lack of sweating on your body; hot or red skin; decreased alertness or passing out; fast, weak pulse; fast, shallow breathing; increased body temperature.
Blurred Vision: Avoid touching eyes. Stop using QBREXZA and call your healthcare provider if you develop blurred vision. Do not drive, operate machinery, or do hazardous work until your vision is clear.
The most common side effects of QBREXZA in clinical studies were dry mouth; dilation of the pupils; sore throat; skin redness, burning/stinging or itching in underarm area; headache; problems with urination; blurred vision; nasal, throat, eye, and skin dryness; and constipation. These are not all the possible side effects of QBREXZA. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Product Information.