Qbrexza™ (glycopyrronium) cloth
Qbrexza is a medicated cloth indicated for the topical treatment of primary axillary hyperhidrosis (excessive underarm sweating).
Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications: Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
WARNINGS AND PRECAUTIONS
Worsening of Urinary Retention: Qbrexza should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.
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, 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.
The most common adverse reactions seen in ≥2% of subjects treated with Qbrexza were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat (2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
Anticholinergics: Coadministration of Qbrexza with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of Qbrexza with other anticholinergic-containing drugs.
INSTRUCTIONS FOR ADMINISTERING QBREXZA
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.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data on Qbrexza use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Qbrexza and any potential adverse effects on the breastfed infant from Qbrexza or from the underlying maternal condition.
Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.
Meer info (Engels): http://pi.dermira.com/QbrexzaPPI.pdf
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.
IMPORTANT SAFETY INFORMATION
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 Sjögren’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.
What should I tell my healthcare provider before using QBREXZA? 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.
• 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
• problems with urination
• blurred vision
• nasal dryness
• throat, eye, and skin dryness
These are not all of the possible side effects of QBREXZA.
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