Important Safety Information

Interstitial Lung Disease (ILD)/Pneumonitis. ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA. 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%). Nine patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis.Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TABRECTA in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified.Hepatotoxicity. Hepatotoxicity occurred in patients treated with TABRECTA. Increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) occurred in 15% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 or 4 increased ALT/AST occurred in 7% of patients. Three patients (0.8%) discontinued TABRECTA due to increased ALT/AST.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. Based on the severity of the adverse reaction, withhold, reduce dose, or permanently discontinue TABRECTA.Pancreatic Toxicity. Elevations in amylase and lipase levels have occurred in patients treated with TABRECTA. Increased amylase/lipase occurred in 14% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 or 4 increased amylase/lipase occurred in 7% and 1.9% of patients, respectively. Three patients (0.8%) discontinued TABRECTA due to increased amylase/lipase. Pancreatitis (grade 3) occurred in 1 patient (0.3%); TABRECTA was permanently discontinued for this event.Monitor amylase and lipase at baseline and regularly during treatment with TABRECTA. Based on the severity of the adverse reaction, temporarily withhold, dose reduce, or permanently discontinue TABRECTA.Hypersensitivity Reactions. Serious hypersensitivity reactions occurred in patients treated with TABRECTA in clinical trials other than GEOMETRY mono-1. Signs and symptoms of hypersensitivity included pyrexia, chills, pruritus, rash, decreased blood pressure, nausea, and vomiting. Based on the severity of the adverse reaction, temporarily withhold or permanently discontinue TABRECTA.Risk of Photosensitivity. Based on findings from animal studies, there is a potential risk of photosensitivity reactions with TABRECTA. In GEOMETRY mono-1, it was recommended that patients use precautionary measures against ultraviolet exposure, such as use of sunscreen or protective clothing, during treatment with TABRECTA. Advise patients to limit direct ultraviolet exposure during treatment with TABRECTA.Embryo-Fetal Toxicity. Based on findings from animal studies and its mechanism of action, TABRECTA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose.Most Common Adverse Reactions. The most common adverse reactions (≥20%) were edema (59%), nausea (46%), musculoskeletal pain (40%), fatigue (34%), vomiting (28%), dyspnea (25%), cough (21%), and decreased appetite (21%). The most common grade 3 adverse reactions (≥2%) were edema (13%), fatigue (8%), dyspnea (7%), pneumonia (6%), musculoskeletal pain (4.3%), nausea (2.4%), and vomiting (2.4%). Grade 4 dyspnea and pneumonia were reported in 0.5% of patients.Clinically Relevant Adverse Reactions. Clinically relevant adverse reactions observed in &lt;10% of patients were pruritus (including allergic pruritus), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.Laboratory Abnormalities. Select laboratory abnormalities (≥20%) worsening from baseline in patients who received TABRECTA were decreased albumin (72%), increased creatinine (65%), decreased lymphocytes (45%), increased ALT (39%), increased amylase (34%), increased alkaline phosphatase (32%), increased gamma-glutamyltransferase (30%), increased lipase (29%), increased AST (28%), decreased phosphate (26%), decreased leukocytes (25%), increased potassium (25%), decreased hemoglobin (24%), decreased sodium (24%), and decreased glucose (23%).Please see full <a href="https://www.novartis.com/us-en/sites/novartis_us/files/tabrecta.pdf" target="_blank">Prescribing Information</a> for TABRECTA.

TABRECTA&nbsp;is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

Indication

Interstitial Lung Disease (ILD)/Pneumonitis. ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA. ILD/pneumonitis occurred in 4.8% of patients treated with TABRECTA in the GEOMETRY mono-1 study, with 1.9% of...

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Important Safety Information

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