Comarit 20 mg (Capsule)

Indications

• Treatment of renal cell carcinoma (RCC)
• Treatment of hepatocellular carcinoma (HCC)

Pharmacology

• Inhibition of MET, VEGFR-1, -2, -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2
• Median time to peak cabozantinib concentrations (Tmax) 3 to 4 hours post-dose
• Oral volume of distribution (Vz/F) of Cabozantinib approximately 319 L
• Cabozantinib is highly protein-bound in human plasma (>99.7%)
• Predicted terminal half-life approximately 99 hours
• Cabozantinib is a substrate of CYP3A4 in vitro
• Approximately 81% of the total administered radioactivity was recovered within a 48-day collection period

Dosage & Administration

• Recommended Dosage for Renal Cell Carcinoma: 60 mg once daily without food
• Recommended Dosage for Hepatocellular Carcinoma: 60 mg once daily without food
• Stop treatment at least 28 days prior to scheduled surgery
• Swallow tablets whole, do not crush
• Do not take a missed dose within 12 hours of the next dose
• Pediatric use not established

Interaction

• Avoid coadministration with strong CYP3A4 inhibitors
• Avoid grapefruit or grapefruit juice
• Avoid coadministration with strong CYP3A4 inducers
• Avoid St. John's Wort

Contraindications

• Known hypersensitivity to Cabozantinib or any other components

Side Effects

• Hemorrhage
• Perforations and Fistulas
• Thrombotic Events
• Hypertension and Hypertensive Crisis
• Diarrhea
• Palmar-plantar Erythrodysesthesia
• Proteinuria
• Osteonecrosis of the Jaw
• Wound Complications
• Reversible Posterior Leukoencephalopathy Syndrome

Pregnancy & Lactation

• Cabozantinib can cause fetal harm when administered to a pregnant woman
• No information regarding presence of Cabozantinib or its metabolites in human milk
• Use effective contraception during treatment and for 4 months after the final dose
• Impairment of fertility in females and males based on animal findings

Precautions & Warnings

• Severe and fatal hemorrhages occurred
• Fistulas and GI perforations occurred in 1% of patients
• Increased risk of thrombotic events
• Can cause hypertension, including hypertensive crisis
• Diarrhea occurred in 63% of patients
• Palmar-plantar Erythrodysesthesia occurred in 44% of patients
• Proteinuria was observed in 7% of patients
• Osteonecrosis of the jaw occurred in <1% of patients
• Wound complications reported
• Reversible Posterior Leukoencephalopathy Syndrome can occur
• Embryo-fetal toxicity

Overdose Effects

• Reported case of overdosage resulting in memory impairment, mental status changes, cognitive disturbance, weight loss, increase in BUN

Therapeutic Class

• Tyrosine Kinase Inhibitor

Storage Conditions

• Store below 30°C in a cool and dry place, away from sunlight
• Keep out of reach of children

Related Brands

• Caboz 20 mg (Capsule) - beacon-pharmaceuticals-plc