Brigatinib Disease Interactions

Following a single dose of 90 mg, unbound brigatinib systemic exposure was 37% higher in subjects with severe hepatic impairment (Child-Pugh C) compared to subjects with normal hepatic function. It is recommended to reduce the dose by approximately 40% (i.e., from 180 mg to 120 mg, 120 mg to 90 mg, or from 90 mg to 60 mg) in these patients. No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A) or moderate hepatic impairment (Child-Pugh B).

Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with the use of brigatinib. It is recommended to monitor for new or worsening respiratory symptoms (e.g., dyspnea, cough, etc.), particularly during the first week of initiating this drug. Withhold brigatinib in any patient with new or worsening respiratory symptoms, and promptly evaluate for ILD/pneumonitis or other causes of respiratory symptoms (e.g., pulmonary embolism, tumor progression, and infectious pneumonia). Dose modifications or permanent discontinuation may be necessary.

Following a single dose of 90 mg, unbound brigatinib systemic exposure was 86% higher in subjects with severe renal impairment [creatinine clearance (CrCl) 15 to 29 mL/min] compared to subjects with normal renal function. It is recommended to reduce dose by approximately 50% (i.e., from 180 mg to 90 mg, or from 90 mg to 60 mg) in these patients. No dose adjustment is recommended for patients with mild or moderate renal impairment [creatinine clearance (CrCl) 30 to 89 mL/min].