Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 shows the adverse reactions occurring at an incidence of ≥2% and higher in BRINSUPRI-treated patients compared to placebo in the safety population from ASPEN.
Table 1 Adverse Reactions with BRINSUPRI with an Incidence of ≥2% and More Common than Placebo in ASPEN Adverse Reaction Placebo (N=563) n (%) BRINSUPRI 10 mg QD (N=582) n (%) BRINSUPRI 25 mg QD (N=574) n (%) Upper respiratory tract infection Upper respiratory tract infection includes coronavirus infection, COVID-19, influenza, upper respiratory tract infection, viral infection, and viral upper respiratory tract infection.
141 (25) 157 (27) 169 (29) Headache 39 (7) 39 (7) 49 (9) Rash Rash includes rash, rash maculo-papular, rash pruritic, rash erythematous, dermatitis, and erythema.
5 WARNINGS AND PRECAUTIONS 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.
Like all medications, Brinsupri can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: