brinsupri
Brinsupri (Brensocatib) is a medication used to treat Bronchiectasis.
Brensocatib · by Insmed Inc
Key facts
- Active ingredient
- Brensocatib
- Form
- Tablet
- Strength
- Brensocatib 10MG · Brensocatib 25MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- bronchiectasis
- Manufacturer
- Insmed Inc
- FDA application
- NDA217673
What is Brinsupri?
From the FDA label:BRINSUPRI (brensocatib) is a dipeptidyl peptidase 1 (DPP1) inhibitor. The chemical name for the active ingredient brensocatib monohydrate is (2 S )- N -{(1 S )-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl)phenyl]ethyl}-1,4-oxazepane-2-carboxamide monohydrate with a chemical formula of C 23 H 24 N 4 O 4 ∙ H 2 O which corresponds to a molecular weight of 438.48 g/mol. Its structural formula is: Brensocatib monohydrate drug substance is a white to off-white solid powder. It is slightly soluble at pH 1.2, freely soluble at pH 4.5, and very slightly soluble at pH 6.8 of aqueous media. It is also soluble in acetonitrile and sparingly soluble in ethanol. BRINSUPRI tablets are available for oral administration in strengths of 10 mg and 25 mg brensocatib with the following inactive ingredients: dibasic calcium phosphate dihydrate, glyceryl dibehenate, microcrystalline cellulose, silicon dioxide, and sodium starch glycolate. The film coating contains ferrosoferric oxide/black iron oxide, iron oxide yellow, and iron oxide red (10 mg) or ferrosoferric oxide/black iron oxide (25 mg), macrogol/PEG, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. Chemical Structure
How to use
Recommended dosage: 10 mg or 25 mg orally once daily with or without food. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of BRINSUPRI is as follows: 10 mg orally once daily with or without food or 25 mg orally once daily with or without food Missed Dose(s) Patients who miss a dose should take the next dose at their regular time the next day. Do not double the dose to make up for the missed dose.
Side effects
The following adverse reactions are described elsewhere in the labeling: Dermatologic Adverse Reactions [see Warnings and Precautions (5.1) ] Gingival and Periodontal Adverse Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Insmed Incorporated at 1-844-4-INSMED or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data below reflect the safety of BRINSUPRI in adult and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis (NCFB). A total of 1721 patients with NCFB were randomized in a double-blind, placebo-controlled clinical trial of 52 weeks duration (ASPEN) [see Clinical Studies (14) ]. The safety of BRINSUPRI was based on data from 1719 adult and pediatric patients aged 12 years and older who received at least one dose of BRINSUPRI or placebo. A total of 1156 patients received at least one dose of BRINSUPRI 10 mg or 25 mg orally once daily. Table 1…
Warnings
Important safety information
Dermatologic Adverse Reactions : Monitor for new rash or skin conditions and refer to dermatology for evaluation. ( 5.1 ) Gingival and Periodontal Adverse Reactions : Gingival and periodontal adverse reactions can occur with BRINSUPRI use. Refer to the dental care services for regular dental checkups and advise patients to perform routine dental hygiene. ( 5.2 ) Live Attenuated Vaccines : It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of the vaccines. Avoid use of live attenuated vaccines. ( 5.3 ) 5.1 Dermatologic Adverse Reactions Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis [see Adverse Reactions (6.1) ]. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. 5.2 Gingival and Periodontal Adverse Reactions Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions [see Adverse Reactions (6.1) ]. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. 5.3 Live Attenuated Vaccines The concomitant use of BRINSUPRI and live attenuated vaccines has not been evaluated. It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.
Who should not take Brinsupri
None. None. ( 4 )
Overdose — what happens if you take too much
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
May treat (source: NIH RxClass)
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Brinsupri treat?
- Brinsupri (Brensocatib) may be used to treat bronchiectasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Brinsupri?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Brinsupri. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Brinsupri?
- Brinsupri is marketed by Insmed Inc. You can see Insmed Inc's full profile, rating, and other products on pharmaranks.
- Is Brinsupri a brand-name or generic drug?
- Brinsupri is a brand-name product with the active ingredient Brensocatib.
- Is Brinsupri available over the counter?
- No. Brinsupri is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Brinsupri come in?
- Brinsupri is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Brinsupri FDA-registered?
- Brinsupri is on record with the U.S. FDA under application number NDA217673. You can verify this on its official FDA label.
- Is Brinsupri safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Brinsupri. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Brinsupri?
- Brinsupri's side effects are taken directly from its FDA label. From the label: The following adverse reactions are described elsewhere in the labeling: Dermatologic Adverse Reactions [see Warnings and Precautions (5.1) ] Gingival and Periodontal Adverse Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥2%): upper respiratory tract infect… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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