Cabanib 60

• Advanced Renal Cell Carcinoma (RCC)
• Hepatocellular Carcinoma (HCC) - in patients previously treated with sorafenib

Adults (RCC and HCC): 60 mg once daily without food until clinical benefit is no longer observed or unacceptable toxicity occurs.

Administration instructions: Take at least 1 hour before or at least 2 hours after eating. Swallow tablets whole; do not crush.

Dose modification: Dose adjustments may be needed for patients with hepatic impairment and those taking CYP450 inhibitors/inducers.

Prior to surgery: Stop cabozantinib at least 28 days prior to scheduled surgery (including dental surgery).

Pediatric: Safety and effectiveness have not been established.

Common side effects: Diarrhea (63%), Palmar-plantar erythrodysesthesia (44%), Hypertension, Proteinuria (7%), Fatigue, Decreased appetite, Nausea, Vomiting, Weight loss, Abdominal pain.

Serious side effects: Hemorrhage (Grade 3 or 4 - discontinue); Perforations and fistulas (GI - 1%); Thrombotic events (Venous 7%, Arterial 2%); Hypertensive crisis; Osteonecrosis of the jaw (ONJ - <1%); Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Wound complications.

• Hemorrhage: Severe and fatal hemorrhages may occur; do not administer to patients with recent history of hemorrhage (hemoptysis, hematemesis, melena); discontinue for Grade 3 or 4 hemorrhage.
• Perforations and Fistulas: GI perforations and fistulas (including fatal) may occur; monitor; discontinue if fistula cannot be appropriately managed or GI perforation occurs.
• Thrombotic Events: Discontinue in patients who develop acute myocardial infarction or serious arterial/venous thromboembolic events.
• Hypertension: Do not initiate in patients with uncontrolled hypertension; monitor blood pressure regularly; withhold until controlled and resume at reduced dose; discontinue for severe hypertension/hypertensive crisis.
• Diarrhea: Withhold until improvement to Grade 1 and resume at reduced dose for intolerable Grade 2, Grade 3 (unmanageable with standard treatment), or Grade 4 diarrhea.
• Palmar-Plantar Erythrodysesthesia (PPE): Withhold until improvement to Grade 1 and resume at reduced dose for intolerable Grade 2 or Grade 3 PPE.
• Proteinuria: Monitor urine protein regularly; discontinue for nephrotic syndrome.
• Osteonecrosis of the Jaw (ONJ): Perform oral examination before and periodically during treatment; withhold for at least 28 days prior to dental surgery.
• Wound Complications: Stop at least 28 days prior to scheduled surgery; resume after adequate wound healing.
• RPLS: Evaluate if seizures, headache, visual disturbances, or confusion occur; discontinue if RPLS develops.
• Contraception: Females of reproductive potential should use effective contraception during treatment and for 4 months after the final dose.