Tabrecta Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: ILD/Pneumonitis (see Precautions); Hepatotoxicity (see Precautions).
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.
Metastatic Non-Small Cell Lung Cancer: The safety of Tabrecta was evaluated in GEOMETRY mono-1 (see Pharmacology: Pharmacodynamics under Actions). Patients received Tabrecta 400 mg orally twice daily until disease progression or unacceptable toxicity (N=334). Among patients who received Tabrecta, 31% were exposed for at least 6 months and 16% were exposed for at least one year.
Serious adverse reactions occurred in 51% of patients who received Tabrecta. Serious adverse reactions in ≥ 2% of patients included dyspnea (7%), pneumonia (4.8%), pleural effusion (3.6%), general physical health deterioration (3%), vomiting (2.4%), and nausea (2.1%). A fatal adverse reaction occurred in one patient (0.3%) due to pneumonitis.
Permanent discontinuation of Tabrecta due to an adverse reaction occurred in 16% of patients. The most frequent adverse reactions (≥ 1%) leading to permanent discontinuation of Tabrecta were peripheral edema (1.8%), pneumonitis (1.8%), and fatigue (1.5%).
Dose interruptions due to an adverse reaction occurred in 54% of patients who received Tabrecta. Adverse reactions requiring dosage interruption in > 2% of patients who received Tabrecta included peripheral edema, increased blood creatinine, nausea, vomiting, increased lipase, increased ALT, dyspnea, increased amylase, increased AST, increased blood bilirubin, fatigue, and pneumonia.
Dose reductions due to an adverse reaction occurred in 23% of patients who received Tabrecta. Adverse reactions requiring dosage reductions in > 2% of patients who received Tabrecta included peripheral edema, increased ALT, increased blood creatinine, and nausea.
The most common adverse reactions (≥ 20%) in patients who received Tabrecta were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
Table 4 summarizes the adverse reactions in GEOMETRY mono-1. (See Table 4.)

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Clinically relevant adverse reactions occurring in < 10% of patients treated with Tabrecta included pruritus (allergic and generalized), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.
Table 5 summarizes the laboratory abnormalities in GEOMETRY mono-1. (See Table 5.)

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