BRINSUPRI 10 mg
583 people
BRINSUPRI 25 mg
575 people
Placebo
563 people
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BRINSUPRI was approved based on 2 clinical studies, ASPEN and WILLOW. Participants received 1 dose, once a day, of either BRINSUPRI 10 mg, BRINSUPRI 25 mg, or for the duration of the studies.
Had non-cystic fibrosis
Had other conditions, including a history of asthma or COPD
Continued using their existing treatments
THE ASPEN STUDY
Participants: 1,721 people 12 years and older
Treatment period: 1 year (52 weeks)
BRINSUPRI 10 mg
583 people
BRINSUPRI 25 mg
575 people
Placebo
563 people
In the WILLOW study, 256 adults were treated once a day for 6 months, with 82 people receiving BRINSUPRI 10 mg, 87 people receiving BRINSUPRI 25 mg, and 87 people receiving placebo.
In the ASPEN study, BRINSUPRI reduced the risk of flares by 21.1% with the 10-mg dose and 19.4% with the 25-mg dose compared to those taking placebo when measured over 1 year.
When measured at 1 year in the ASPEN study, 48.5% of people taking BRINSUPRI 10 mg (283/583) or BRINSUPRI 25 mg (279/575) had no flares compared to 40.3% of people taking a placebo (227/563).
Studies have shown that lung function naturally declines over time for everyone, but people with bronchiectasis experience greater decline. In the ASPEN study, BRINSUPRI 25 mg was shown to help reduce lung function decline when compared to placebo.
Post-bronchodilator , a common test that determines how well your lungs are working, was measured at 1 year in the ASPEN study. People taking placebo saw a decline of 62 mL compared with 50 mL for those taking BRINSUPRI 10 mg. The difference in FEV1 between the 10-mg dose and placebo was not significant.
People taking BRINSUPRI 25 mg saw a decline of 24 mL, which was a 61% reduction in lung function decline when compared to a 62-mL decline for those taking placebo.
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Before taking BRINSUPRI, tell your healthcare provider about all of your medical conditions, including if you:
have recently received or are scheduled to receive any live attenuated vaccinations.
are pregnant or plan to become pregnant. It is not known if BRINSUPRI will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if BRINSUPRI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not change or stop your medicines unless your healthcare provider tells you to.
BRINSUPRI may cause serious side effects including:
Skin problems. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination, if needed.
Dental problems. Get regular dental checkups while taking BRINSUPRI. Brush and clean your teeth as recommended by your dentist. Tell your healthcare provider and contact your dentist if you experience new gum (gingival) or teeth (dental) symptoms.
Common side effects of BRINSUPRI
The most common side effects of BRINSUPRI include upper respiratory tract infection, headache, rash, dry skin, small areas of skin thickening (hyperkeratosis), and high blood pressure (hypertension).
Less common side effects include abnormal liver blood test, hair loss (alopecia), and skin cancers.
These are not all of the possible side effects of BRINSUPRI.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
BRINSUPRI is a prescription medicine used to treat non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years of age and older. It is not known if BRINSUPRI is safe and effective in children under 12 years of age.
Please see full Prescribing Information and Patient Information.
Before taking BRINSUPRI, tell your healthcare provider about all of your medical conditions, including if you:
have recently received or are scheduled to receive any live attenuated vaccinations.
are pregnant or plan to become pregnant. It is not known if BRINSUPRI will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if BRINSUPRI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not change or stop your medicines unless your healthcare provider tells you to.
BRINSUPRI may cause serious side effects including:
Skin problems. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination, if needed.
Dental problems. Get regular dental checkups while taking BRINSUPRI. Brush and clean your teeth as recommended by your dentist. Tell your healthcare provider and contact your dentist if you experience new gum (gingival) or teeth (dental) symptoms.
Common side effects of BRINSUPRI
The most common side effects of BRINSUPRI include upper respiratory tract infection, headache, rash, dry skin, small areas of skin thickening (hyperkeratosis), and high blood pressure (hypertension).
Less common side effects include abnormal liver blood test, hair loss (alopecia), and skin cancers.
These are not all of the possible side effects of BRINSUPRI.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
BRINSUPRI is a prescription medicine used to treat non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years of age and older. It is not known if BRINSUPRI is safe and effective in children under 12 years of age.
Please see full Prescribing Information and Patient Information.