Active Ingredient: Cabozantinib
Cabozantinib is indicated for the treatment of advanced renal cell carcinoma (RCC):
For this indication, competent medicine agencies globally authorize below treatments:
Oral
60 - 60 mg
From 60 To 60 mg once every day
For RCC and HCC, the recommended dose of cabozantinib is 60 mg once daily. Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction of cabozantinib therapy (see table). When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily. Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities. Dose reductions are recommended for events that, if persistent, could become serious or intolerable.
If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
Recommended cabozantinib dose modifications for adverse reactions:
| Adverse reaction and severity | Treatment Modification |
|---|---|
| Grade 1 and Grade 2 adverse reactions which are tolerable and easily managed | Dose adjustment is usually not required. Add supportive care as indicated. |
| Grade 2 adverse reactions which are intolerable and cannot be managed with a dose reduction or supportive care | Interrupt treatment until the adverse reaction resolves to Grade ≤1. Add supportive care as indicated. Consider re-initiating at a reduced dose. |
| Grade 3 adverse reactions (except clinically nonrelevant laboratory abnormalities) | Interrupt treatment until the adverse reaction resolves to Grade ≤1. Add supportive care as indicated. Re-initiate at a reduced dose. |
| Grade 4 adverse reactions (except clinically nonrelevant laboratory abnormalities) | Interrupt treatment. Institute appropriate medical care. If adverse reaction resolves to Grade ≤1, re-initiate at a reduced dose. If adverse reaction does not resolve, permanently discontinue cabozantinib. |
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking cabozantinib.
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