CABOZANTINIB
Cabozantinib suppresses metastasis, angiogenesis, and oncognesis by inhibiting receptor tyrosine kinases. Cabozantinib inhibits specific receptor tyrosine kinases such as VEGFR-1, -2 and -3, KIT, TRKB, FLT-3, AXL, RET, MET, and TIE-2.Indications:- 1. Renal Cell Carcinoma -CABOZANTINIB is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). -CABOZANTINIB, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC. 2. Hepatocellular Carcinoma -CABOZANTINIB is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 3. Differentiated Thyroid Cancer CABOZANTINIB is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFRtargeted therapy and who are radioactive iodine-refractory or ineligible.
Oral; 20. 40. 60 mg Recommended Dosage for Renal Cell Carcinoma -The recommended dosage of CABOZANTINIB as a single agent is 60 mg once daily until disease progression or unacceptable toxicity administered as recommended . The recommended dosage of CABOZANTINIB in combination with nivolumab. -Recommended Dosage Duration of Therapy CABOZANTINIB 40 mg once daily without food until disease progression or unacceptable toxicity Nivolumab 240 mg every 2 weeks (30-minute intravenous infusion) or 480 mg every 4 weeks (30- minute intravenous infusion) -Recommended Dosage Duration of Therapy CABOZANTINIB 40 mg once daily without food until disease progression or unacceptable toxicity. Until disease progression or unacceptable toxicity for up to 2 years Recommended Dosage for Hepatocellular Carcinoma The recommended dosage of CABOZANTINIB as a single agent is 60 mg once daily until disease progression or unacceptable toxicity administered as recommended Recommended Dosage for Differentiated Thyroid Cancer -The recommended dosage of CABOZANTINIB as a single agent for adult and pediatric patients 12 years of age and older with BSA greater than or equal to 1.2 m2 is 60 mg once daily until disease progression or unacceptable toxicity administered as recommended. -The recommended dosage of CABOZANTINIB as a single agent in pediatric patients 12 years of age and older with BSA less than 1.2 m2 is 40 mg once daily until disease progression or unacceptable toxicity administered as recommended
Hypersensitivity.
Paediatric: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing CABOZANTINIB if abnormalities occur Pregnancy: Potential risk to fetus Lactation: Advised not to breastfeed. Elderly: No overall differences in safety or effectiveness were observed between these patients and younger patients.
Hemorrhage, Perforations and Fistulas, Thrombotic Events, Hypertension and Hypertensive Crisis, Diarrhea , Palmar-plantar Erythrodysesthesia, Hepatotoxicity, Adrenal Insufficiency , Proteinuria , Osteonecrosis of the Jaw , Impaired Wound Healing , Reversible Posterior Leukoencephalopathy Syndrome, Thyroid Dysfunction , Hypocalcemia.
-With Strong CYP3A4 inhibitors: Reduce the CABOZANTINIB dosage if coadministration cannot be avoided. -With Strong CYP3A4 inducers: Increase the CABOZANTINIB dosage if coadministration cannot be avoided.
