Chinese Prescribing Information for Cabozantinib (Cabometyx)

Cabozantinib (Cabometyx) was first approved by the FDA in 2012. It is a non‑specific tyrosine kinase inhibitor that exerts antitumor activity by selectively inhibiting the MET, VEGFR2, and RET signaling pathways. It can kill tumor cells, reduce metastasis, and inhibit angiogenesis.

Indications for Cabozantinib (Cabometyx)

Cabozantinib (Cabometyx) is a kinase inhibitor. The FDA has approved it for the treatment of the following patients:

Patients with advanced renal cell carcinoma (RCC).

Patients with advanced renal cell carcinoma (RCC), for use in combination with nivolumab as first‑line treatment.

Patients with hepatocellular carcinoma (HCC) who have previously received sorafenib.

Adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that has progressed following prior VEGFR‑targeted therapy and who are refractory to or not eligible for radioactive iodine therapy.

Adult and pediatric patients aged 12 years and older with previously treated, unresectable locally advanced or metastatic well‑differentiated pancreatic neuroendocrine tumors (pNET).

Adult and pediatric patients aged 12 years and older with previously treated, unresectable locally advanced or metastatic well‑differentiated extrapancreatic neuroendocrine tumors (epNET).

Dosage and Administration of Cabozantinib (Cabometyx)

1. Cabozantinib (Cabometyx) Monotherapy

60 mg orally once daily for patients weighing ≥40 kg.

Continue until disease progression or unacceptable toxicity.

2. Cabozantinib (Cabometyx) in Combination with Nivolumab

40 mg orally once daily.

Continue until disease progression or unacceptable toxicity.

3. Pediatric Patients (≥12 years and <40 kg)

40 mg orally once daily.

Continue until disease progression or unacceptable toxicity.

Adverse Reactions of Cabozantinib (Cabometyx)

Adverse reactions highlighted in the FDA Prescribing Information include:

1. Serious Adverse Reactions

(1) Gastrointestinal Perforation or Fistula

Cabozantinib (Cabometyx) may cause gastrointestinal perforation or fistula formation. Contact a physician immediately if severe abdominal pain or choking sensations while eating or drinking occur.

(2) Other Serious Adverse Reactions

Severe headache, blurred vision, pounding in the neck or ears;

persistent severe vomiting, diarrhea, or constipation;

swelling of hands or feet;

unusual bleeding (nosebleeds, gum bleeding, heavy menstrual bleeding, or uncontrolled bleeding);

bloody/black stools, coughing up blood, or vomit that resembles coffee grounds;

jaundice (yellowing of skin or eyes);

pain, blistering, bleeding, or severe rash on palms or soles;

confusion, altered mental status, seizures;

dizziness or fainting;

jaw pain or numbness, swollen gums, loose teeth, or delayed healing after dental procedures.

2. Laboratory Abnormalities

Hypocalcemia (muscle spasms, numbness around the mouth or fingertips);

leukopenia (fever, mouth ulcers, difficulty breathing);

adrenal insufficiency (nausea, extreme fatigue, syncope).

3. Common Adverse Reactions

Fatigue, depressed mood, dry skin, hair loss, cold intolerance, weight gain;

abdominal pain, nausea, decreased appetite, diarrhea or constipation;

mouth pain or ulcers;

taste changes, speech disorders;

cold‑like symptoms (nasal congestion, cough, sore throat);

rash, joint and muscle pain;

liver function abnormalities, weight loss, hair depigmentation.

Missed Dose of Cabozantinib (Cabometyx)

Take the missed dose as soon as you remember. If it is less than 12 hours until your next scheduled dose, skip the missed dose. Do not take two doses of Cabozantinib (Cabometyx) at one time.