Tabrecta Dosage/Direction for Use

Select patients for treatment with Tabrecta based on the presence of a mutation that leads to MET exon 14 skipping in tumor specimens.
Posology: The recommended dosage of Tabrecta is 400 mg orally twice daily with or without food.
Dose modifications: The recommended dose reductions for the management of adverse reactions are listed in Table 2. (See Table 2.)

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Permanently discontinue Tabrecta in patients who are unable to tolerate 200 mg orally twice daily.
The recommended dosage modifications of Tabrecta for adverse reactions are provided in Table 3. (See Table 3.)

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Special populations: Pediatric Use: Safety and effectiveness of Tabrecta in pediatric patients have not been established.
Geriatric Use: In GEOMETRY mono-1, 57% of the 334 patients were 65 years or older and 16% were 75 years or older. No overall differences in the safety or effectiveness were observed between these patients and younger patients.
Renal Impairment: No dosage adjustment is recommended in patients with mild (baseline creatinine clearance [CLcr] 60 to 89 mL/min by Cockcroft-Gault) or moderate renal impairment (CLcr 30 to 59 mL/min) (see Pharmacology: Pharmacokinetics under Actions). Tabrecta has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min).
Method of administration: Swallow Tabrecta tablets whole. Do not break, crush or chew the tablets.
If a patient misses or vomits a dose, instruct the patient not to make up the dose, but to take the next dose at its scheduled time.