Pancreatitis (grade 3) occurred in 1 patient (0.3%) TABRECTA was permanently discontinued for this event. Three patients (0.8%) discontinued TABRECTA due to increased amylase/lipase. Grade 3 or 4 increased amylase/lipase occurred in 7% and 1.9% of patients, respectively. Increased amylase/lipase occurred in 14% of patients treated with TABRECTA in GEOMETRY mono-1. Elevations in amylase and lipase levels have occurred in patients treated with TABRECTA. Based on the severity of the adverse reaction, withhold, reduce dose, or permanently discontinue TABRECTA. ![]() Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TABRECTA, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Three patients (0.8%) discontinued TABRECTA due to increased ALT/AST. Grade 3 or 4 increased ALT/AST occurred in 7% of patients. Increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) occurred in 15% of patients treated with TABRECTA in GEOMETRY mono-1. Hepatotoxicity occurred in patients treated with TABRECTA. Immediately withhold TABRECTA in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/ pneumonitis are identified. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). ![]() Nine patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis. ILD/pneumonitis occurred in 4.8% of patients treated with TABRECTA in the GEOMETRY mono-1 study, with 1.9% of patients experiencing grade 3 ILD/pneumonitis and 1 patient experiencing death (0.3%). ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA. Interstitial Lung Disease (ILD)/Pneumonitis.
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