Source: FDA, National Drug Code (US) Revision Year: 2020
TABRECTA 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.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Select patients for treatment with TABRECTA based on the presence of a mutation that leads to MET exon 14 skipping in tumor specimens [see Clinical Studies (14)].
The recommended dosage of TABRECTA is 400 mg orally twice daily with or without food.
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.
The recommended dose reductions for the management of adverse reactions are listed in Table 1.
Table 1. Recommended TABRECTA Dose Reductions for Adverse Reactions:
| Dose Reduction | Dose and Schedule |
|---|---|
| First | 300 mg orally twice daily |
| Second | 200 mg orally twice daily |
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 2.
Table 2. Recommended TABRECTA Dosage Modifications for Adverse Reactions:
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1)] | Any grade | Permanently discontinue TABRECTA. |
| Increased ALT and/or AST without increased total bilirubin [see Warnings and Precautions (5.2)] | Grade 3 | Withhold TABRECTA until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume TABRECTA at the same dose; otherwise resume TABRECTA at a reduced dose. |
| Grade 4 | Permanently discontinue TABRECTA. | |
| Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis [see Warnings and Precautions (5.2)] | ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN | Permanently discontinue TABRECTA. |
| Increased total bilirubin without concurrent increased ALT and/or AST [see Warnings and Precautions (5.2)] | Grade 2 | Withhold TABRECTA until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume TABRECTA at the same dose; otherwise resume TABRECTA at a reduced dose. |
| Grade 3 | Withhold TABRECTA until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume TABRECTA at a reduced dose; otherwise permanently discontinue TABRECTA. | |
| Grade 4 | Permanently discontinue TABRECTA. | |
| Other Adverse Reactions [see Adverse Reactions (6.1)] | Grade 2 | Maintain dose level. If intolerable, consider withholding TABRECTA until resolved, then resume TABRECTA at a reduced dose. |
| Grade 3 | Withhold TABRECTA until resolved, then resume TABRECTA at a reduced dose. | |
| Grade 4 | Permanently discontinue TABRECTA. |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; ULN, upper limit of normal.
Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events).
Dispense in the original package with the desiccant cartridge. Store at 20˚C to 25˚C (68˚F to 77˚F), excursions permitted between 15˚C and 30˚C (59˚F and 86˚F) [see USP Controlled Room Temperature]. Protect from moisture.
Discard any unused TABRECTA remaining after 6 weeks of first opening the bottle.
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