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Cometriq

cabozantinib
Multi-Kinase InhibitorFDA Approved 2012Exelixis
Route
Oral
Half-Life
99 hrs
FDA Approved
2012
Manufacturer
Exelixis
1. Indications and Usage

Progressive, metastatic medullary thyroid cancer. Note: Cabometyx (tablets) is the formulation for RCC and HCC.

2. Dosage and Administration

140 mg orally once daily on empty stomach.

3. Dosage Forms and Strengths

Capsules: 20 mg, 80 mg

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Hemorrhage: Severe and fatal hemorrhages reported.
  • GI Perforations/Fistulas: Monitor and discontinue if perforation occurs.
  • Thrombotic Events: Arterial and venous thromboembolism reported.
  • Hypertension: Monitor and manage.
  • PPES: Dose reduction may be required.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (63%), Stomatitis (51%), PPES (50%), Weight Loss (48%), Decreased Appetite (46%), Nausea (43%), Fatigue (41%), Dysgeusia (34%), Hypertension (33%)

Diarrhea
63%
Stomatitis
51%
PPES
50%
Weight Loss
48%
Decreased Appetite
46%
Nausea
43%
Fatigue
41%
Dysgeusia
34%
Hypertension
33%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inhibitors: Reduce dose by 40 mg daily.
Strong CYP3A4 Inducers: Increase dose by 40 mg daily (max 180 mg).

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Cabozantinib inhibits MET, VEGFR-1/2/3, RET, KIT, AXL, FLT3, and TIE2. In medullary thyroid cancer, RET mutations drive tumor growth; cabozantinib blocks these pathways.

Pharmacokinetics

Tmax: 2-5 hours. Protein binding: >=99.7%. Half-life: ~55 hours. Elimination: feces 54%, urine 27%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
FDA-Approved Tumor Types

Cometriq has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

External Resources
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Cometriq. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Cometriq (cabozantinib) approved for?

Cometriq (cabozantinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Cometriq (cabozantinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Cometriq (cabozantinib) work?

Cabozantinib inhibits MET, VEGFR-1/2/3, RET, KIT, AXL, FLT3, and TIE2. In medullary thyroid cancer, RET mutations drive tumor growth; cabozantinib blocks these pathways.

What are the most common side effects?

Diarrhea (63%), Stomatitis (51%), PPES (50%), Weight Loss (48%), Decreased Appetite (46%), Nausea (43%), Fatigue (41%), Dysgeusia (34%), Hypertension (33%) Diarrhea 63% Stomatitis 51% PPES 50% Weight Loss 48% Decreased Appetite 46% Nausea 43% Fatigue 41% Dysgeusia 34% Hypertension 33%