Overview of Cabozantinib (LuciCaboz)

Cabozantinib (LuciCaboz), tablets 20mg. Date of first US approval: 2012.

Indications

Cabozantinib (LuciCaboz) is a kinase inhibitor indicated for the treatment of: advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), locally advanced or metastatic differentiated thyroid cancer (DTC).

Dosage and Administration

Stop treatment with Cabozantinib (LuciCaboz) at least 3 weeks prior to scheduled surgery. Do not substitute Cabozantinib capsules for Cabozantinib (LuciCaboz) tablets.

Recommended Dosage

Renal Cell Carcinoma (RCC): 60 mg orally once daily until disease progression or unacceptable toxicity.

Hepatocellular Carcinoma (HCC): 60 mg orally once daily until disease progression or unacceptable toxicity.

Differentiated Thyroid Cancer (DTC): 60 mg orally once daily until disease progression or unacceptable toxicity.

Administration Instructions

Take tablets at least 1 hour before or 2 hours after a meal. Avoid taking Cabozantinib (LuciCaboz) with food.

Missed Dose

Do not take a missed dose if less than 12 hours remain until the next dose.

Dosage Modifications

Reduce the dose in patients with hepatic impairment.

Reduce the dose in patients taking strong CYP3A4 inhibitors.

Increase the dose in patients taking strong CYP3A4 inducers.

Use in Specific Populations

Lactation: Advise not to breastfeed.

Hepatic Impairment: Avoid use in patients with severe hepatic impairment.

Pediatrics: Cabozantinib (LuciCaboz) is not recommended for use in pediatric patients.

Dosage Forms and Strengths

Tablets: 20mg.

Contraindications

None.

Warnings and Precautions

Perforations and Fistulas: Monitor for symptoms. Discontinue Cabozantinib (LuciCaboz) for Grade 4 or uncontrolled Grade 3 events.

Thromboembolic Events: Discontinue Cabozantinib (LuciCaboz) for myocardial infarction or serious venous or arterial thromboembolic events.

Hypertension and Hypertensive Crisis: Monitor blood pressure regularly. Withhold Cabozantinib (LuciCaboz) for inadequately controlled hypertension. Discontinue Cabozantinib (LuciCaboz) for hypertensive crisis or severe hypertension that cannot be controlled with antihypertensive therapy.

Diarrhea: May be severe. Treat with standard antidiarrheal therapy, withhold Cabozantinib (LuciCaboz) until diarrhea resolves or improves to Grade ≤1, then reduce the dose of Cabozantinib (LuciCaboz) or discontinue.

Palmar-Plantar Erythrodysesthesia (PPE): Use standard supportive care, withhold Cabozantinib (LuciCaboz) until PPE resolves or improves to Grade ≤1, then reduce the dose of Cabozantinib (LuciCaboz) or discontinue.

Proteinuria: Monitor urine protein. Withhold Cabozantinib (LuciCaboz) until recovery to Grade ≤1. Discontinue Cabozantinib (LuciCaboz) for nephrotic syndrome.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Cabozantinib (LuciCaboz).

Embryo-Fetal Toxicity: Can cause fetal harm. Inform females of reproductive potential of the potential risk to a fetus and use effective contraception.

Adverse Reactions

The most common adverse reactions (≥20%) are diarrhea, fatigue, nausea, vomiting, decreased appetite, palmar-plantar erythrodysesthesia syndrome, hypertension, hypothyroidism, stomatitis, dysgeusia, abdominal pain, and rash.

Drug Interactions

Strong CYP3A4 Inhibitors: If concomitant use cannot be avoided, reduce the dose of Cabozantinib (LuciCaboz).

Strong CYP3A4 Inducers: If concomitant use cannot be avoided, increase the dose of Cabozantinib (LuciCaboz).