Tabrecta Special Precautions

Interstitial Lung Disease (ILD)/Pneumonitis: ILD/pneumonitis, which can be fatal, occurred in patients treated with Tabrecta (see Adverse Reactions). ILD/pneumonitis occurred in 4.5% of patients treated with Tabrecta in GEOMETRY mono-1, with 1.8% of patients experiencing Grade 3 ILD/pneumonitis and one patient experiencing death (0.3%). Eight patients (2.4%) discontinued Tabrecta due to ILD/pneumonitis. The median time-to-onset of Grade 3 or higher ILD/pneumonitis was 1.4 months (range: 0.2 months to 1.2 years).
Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., 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 (see Dosage & Administration).
Hepatotoxicity: Hepatotoxicity occurred in patients treated with Tabrecta (see Adverse Reactions). Increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) occurred in 13% of patients treated with Tabrecta in GEOMETRY mono-1. Grade 3 or 4 increased ALT/AST occurred in 6% of patients. Three patients (0.9%) discontinued Tabrecta due to increased ALT/AST. The median time-to-onset of Grade 3 or higher increased ALT/AST was 1.4 months (range: 0.5 to 4.1 months).
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, dose reduce, or permanently discontinue Tabrecta (see Dosage & Administration).
Risk of Photosensitivity: Based on findings from animal studies, there is a potential risk of photosensitivity reactions with Tabrecta (see Pharmacology: Toxicology: Preclinical safety data under Actions). 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.
Effects on ability to drive and use machines: No relevant studies have been conducted. Caution is advised when driving and using machines as taking Tabrecta may cause nausea or fatigue (see Adverse Reactions).
Use in Pregnancy: 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. Oral administration of capmatinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at exposures less than the human exposure based on area under the curve (AUC) at the 400 mg twice daily clinical dose. 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 (see Use in Pregnancy & Lactation).