INDICATIONS AND USAGE（适应症）

Renal Cell Carcinoma

CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC.

Hepatocellular Carcinoma

CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Differentiated Thyroid Cancer

CABOMETYX 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 VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.

DOSAGE（服用剂量）

Important Dosage Information

·Stop treatment with CABOMETYX at least 3 weeks prior to scheduled surgery, including dental surgery.

·Do not substitute CABOMETYX tablets with cabozantinib capsules.

Recommended Dosage for Renal Cell Carcinoma

The recommended dosage of CABOMETYX as a single agent is 60 mg once daily until disease progression or unacceptable toxicity administered as recommended.

The recommended dosage of CABOMETYX in combination with nivolumab is provided in the following table:

Recommended Dosage for Hepatocellular Carcinoma

The recommended dosage of CABOMETYX 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 CABOMETYX 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 CABOMETYX 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.

ADVERSE REACTIONS（不良反应）

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

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/3850cce2-6137-42e5-a792-d318c4a4b3b5/spl-doc?hl=Cabozantinib

Cabozanixinformation