Renal Cell Carcinoma (RCC)

Active Ingredient: Cabozantinib

Indication for Cabozantinib

Population group: only adults (18 years old or older)

Cabozantinib is indicated for the treatment of advanced renal cell carcinoma (RCC):

  • in treatment-naïve adults with intermediate or poor risk
  • in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy

For this indication, competent medicine agencies globally authorize below treatments:

60 mg once daily

Route of admnistration

Oral

Defined daily dose

60 - 60 mg

Dosage regimen

From 60 To 60 mg once every day

Detailed description

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).

Dosage considerations

Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking cabozantinib.

Active ingredient

Cabozantinib

Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, drug resistance, and metastatic progression of cancer. Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors. In addition, cabozantinib inhibits other tyrosine kinases including the GAS6 receptor (AXL), RET, ROS1, TYRO3, MER, the stem cell factor receptor (KIT), TRKB, Fms-like tyrosine kinase-3 (FLT3), and TIE-2.

Read more about Cabozantinib

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