Active Ingredient: Repotrectinib
Repotrectinib as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 160 milligrams repotrectinib, once daily, over the duration of 14 days. Afterwards, oral, 160 milligrams repotrectinib, 2 times daily.
The recommended dose in adults is 160 mg repotrectinib once daily for 14 days, followed by 160 mg repotrectinib twice daily until disease progression or unacceptable toxicity.
If a dose is missed or if a patient vomits at any time after taking a dose, subsequent doses should be resumed as prescribed. Two doses should not be taken at the same time.
The recommended dose reductions for adverse reactions are provided in Table 1:
Table 1. Recommended dose reductions for adverse reactions:
| Prescribed dose | Dose reduction | |
|---|---|---|
| First occurrence | Second occurrence | |
| 160 mg once daily | 120 mg once daily | 80 mg once daily |
| 160 mg twice daily | 120 mg twice daily | 80 mg twice daily |
Recommended dose modifications for specific adverse reactions are provided in Table 2.
Table 2. Recommended dose modifications for specific adverse reactions:
| Adverse reactions | Severity* | Dosage modification |
|---|---|---|
| Central nervous system effects | Intolerable Grade 2 | • Withhold until less than or equal to Grade 1 or baseline. • Resume at same or reduced dose, as clinically appropriate. |
| Grade 3 | • Withhold until less than or equal to Grade 1 or baseline. • Resume at reduced dose. | |
| Grade 4 | • Permanently discontinue. | |
| Interstitial lung disease (ILD)/Pneumonitis | Any Grade | • Withhold if ILD/pneumonitis is suspected. • Permanently discontinue if ILD/pneumonitis is confirmed. |
| Other clinically relevant adverse reactions | Intolerable Grade 2 | • Withhold until less than or equal to Grade 1 or baseline. • Resume at the same or reduced dose if resolution occurs within 4 weeks. |
| Grade 3 or 4 | • Withhold until adverse reaction resolves or improves to recovery or improvement to Grade 1 or baseline. • Resume at the same or reduced dose if resolution occurs within 4 weeks. • Permanently discontinue if adverse reaction does not resolve within 4 weeks. • Permanently discontinue for recurrent Grade 4 events. |
* Graded per NCI Common Terminology Criteria for Adverse Events 4.0
Repotrectinib should be taken at the same time every day.
Repotrectinib may be taken with or without food but should not be taken with grapefruit, grapefruit juice or Seville oranges.
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