Cabozantinib laurylsulfate

1. INDICATIONS AND USAGE OMCAZIO is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab. patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET).

In vitro biochemical and/or cellular assays have shown that cabozantinib inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

2. DOSAGE AND ADMINISTRATION OMCAZIO is NOT substitutable on a mg-to-mg basis with other cabozantinib products. Stop treatment with OMCAZIO at least 3 weeks prior to scheduled surgery, including dental surgery. OMCAZIO may be administered with or without food. Recommended Dose: RCC: 34.5 mg orally once daily as a single agent. RCC: 23 mg orally once daily in combination with nivolumab or nivolumab and hyaluronidase-nvhy. HCC: 34.5 mg orally, once daily. epNET: Adult patients and pediatric patients 12 years of age and older with bodyweight greater than or equal to 40 kg: 34.5 mg orally once daily. Pediatric patients 12 years of age and older with bodyweight less than 40 kg: 23 mg orally once daily. See Full Prescribing Information for dosage modifications of OMCAZIO due to adverse reactions. Hepatic Impairment: Reduce the OMCAZIO dosage for patients with moderate hepatic impairment.

None. None.

Boxed warning: is not substitutable on a mg-to-mg basis with other cabozantinib products. Inappropriate substitution or incorrect conversion of OMCAZIO capsules for another cabozantinib product can increase the risk of serious adverse reactions. Confirm that the intended cabozantinib product at the intended dosage and strength is being prescribed and dispensed. Risk of Serious Adverse Reactions or Reduced Effectiveness Due to Medication Errors: Cabozantinib is available in multiple dosage forms and strengths. OMCAZIO is not substitutable on a mg-to-mg basis with other cabozantinib products. Confirm that the intended cabozantinib product is being prescribed and dispensed. Hemorrhage: Do not administer OMCAZIO if recent history of hemorrhage. Perforations and Fistulas: Monitor for symptoms. Discontinue OMCAZIO for Grade 4 fistula or perforation.

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hemorrhage Perforations and Fistulas Thromboembolic Events Hypertension and Hypertensive Crisis Cardiac Failure Diarrhea Palmar-Plantar Erythrodysesthesia Hepatotoxicity Adrenal Insufficiency Proteinuria Osteonecrosis of the Jaw Impaired Wound Healing Reversible Posterior Leukoencephalopathy Syndrome Thyroid Dysfunction The most common (≥20%) adverse reactions are: as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, decreased weight, constipation. in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

Strong CYP3A inhibitors: Reduce the OMCAZIO dosage if coadministration cannot be avoided. Strong or moderate CYP3A inducers: Increase the OMCAZIO dosage if coadministration cannot be avoided.

Store OMCAZIO at 20°C to 25°C (68°F to 77°F), excursions are permitted from 15°C to 30°C (59°F to 86°F).