Brand name: CABOZAN
Composition:
Each capsule contains:
Cabozantinib (S)-Malate…………….20mg
Indications:
CABOZAN is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC), renal cell carcinoma and hepatocellular carcinoma.
Dosage:
• Recommended Dose: 140 mg orally, once daily.
• Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking CABOZAN.
• Hepatic Impairment: The recommended starting dose of CABOZAN is 80 mg in patients with mild or moderate hepatic impairment.
Contraindications:
• Hypersensitivity to this drug or any ingredient in the formulation.
Warning:
• Risk of GI Perforations and Fistulas: Monitor for symptoms. Discontinue CABOZAN if Grade 4 fistula or perforation occurs.
• Hemorrhage: Do not administer CABOZAN if recent history of hemorrhage.
• Thrombotic Events: Discontinue CABOZAN for myocardial infarction or serious arterial or venous thromboembolic events.
• Impaired Wound Healing: Withhold CABOZAN for at least 3 weeks before elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of CABOZAN after resolution of wound healing complications has not been established.
• Hypertension and hypertensive crisis: Monitor blood pressure regularly. Interrupt for hypertension that is not adequately controlled with anti-hypertensive therapy. Discontinue CABOZAN for hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy.
• Osteonecrosis of the Jaw (ONJ): Withhold CABOZAN for at least 3 weeks prior to invasive dental procedure and for development of ONJ.
• Diarrhea: May be severe. Interrupt CABOZAN immediately until diarrhea resolves or decreases to Grade 1.
• Palmar-Plantar Erythrodysesthesia (PPE): Interrupt CABOZAN until PPE resolves or decreases to Grade 1.
• Proteinuria: Monitor urine protein. Discontinue in case of nephrotic syndrome.
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue CABOZAN.
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Adverse Effects:
• The most common adverse reactions (≥ 25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia (PPE), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation.
• The most common laboratory abnormalities (≥ 25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.
Dosage form: Blue capsule.
Expiry date: 24 months after date of manufacture.
Packaging:
• 90 capsules per bottle.
Storage:
• Store in original packaging in a cool and dry place below 30ᵒC, protect from light.
• Keep out of reach of children.
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Do not self-diagnose or treat any medical condition based solely on the information on this website. If you have any questions or concerns about a medication, please talk to your doctor or pharmacist.
