Skip to content
MedsAcross

Molecule

Cabozantinib s-malate

Kinase Inhibitor
Available on requestOrphan
Presentations
4
Brands
2
Manufacturers
1
Available from stock
0

Cabozantinib s-malate is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). It is available as tablets and capsules for oral use. MedsAcross supplies Cabozantinib s-malate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Kinase Inhibitor, Protein Kinase Inhibitors
US FDA first approval
29 November 2012
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Capsule
Identifiers
UNII DR7ST46X58RxCUI 1363267CAS 1140909-48-3Q27139901

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).

Source: US FDA prescribing information

How it works

In vitro biochemical and/or cellular assays have shown that cabozantinib inhibits the tyrosine kinase activity of RET, MET, VEGFR-1, -2 and -3, KIT, TRKB, FLT-3, AXL, ROS1, TYRO3, MER, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

Source: US FDA prescribing information

Dosing overview

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 COMETRIQ. Do NOT substitute COMETRIQ capsules with cabozantinib tablets. Hepatic Impairment: The recommended starting dose of COMETRIQ is 80 mg in patients with mild or moderate hepatic impairment.

Source: US FDA prescribing information

Warnings and precautions

Perforations and Fistulas: Monitor for symptoms. Discontinue COMETRIQ for Grade 4 fistula or perforation. Hemorrhage: Do not administer COMETRIQ if recent history of hemorrhage. Thrombotic Events: Discontinue COMETRIQ for myocardial infarction or serious arterial or venous thromboembolic events. Impaired Wound Healing: Withhold COMETRIQ 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 COMETRIQ 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 COMETRIQ for hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Perforations and Fistula Hemorrhage Thromboembolic Events Impaired Wound Healing Hypertension and Hypertensive Crisis Cardiac Failure Osteonecrosis of the Jaw Diarrhea Palmar-Plantar Erythrodysesthesia Proteinuria Reversible Posterior Leukoencephalopathy Syndrome Hypocalcemia 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.

Source: US FDA prescribing information

Interactions

Strong CYP3A4 Inhibitors: Reduce the COMETRIQ dosage. Strong CYP3A4 Inducers: Increase the COMETRIQ dosage. Effect of CYP3A4 Inhibitors Administration of a strong CYP3A4 inhibitor, ketoconazole to healthy subjects increased single-dose plasma cabozantinib exposure by 38%. Avoid taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while taking COMETRIQ or reduce the dosage of COMETRIQ if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Avoid ingestion of foods (e.g., grapefruit, grapefruit juice) or nutritional supplements that are known to inhibit cytochrome P450 while taking COMETRIQ. Effect of CYP3A4 Inducers Administration of a strong CYP3A4 inducer, rifampin to healthy subjects decreased single-dose plasma cabozantinib exposure by 77%.

Source: US FDA prescribing information

Storage

Store COMETRIQ at 20°C to 25°C (68°F to 77°F), excursions are permitted from 15°C to 30°C (59°F to 86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Cabozantinib s-malate, sorted by availability.

MedicineManufacturerRegisterAvailability
Cabometyx 20 mg tabletOralExelixisUS FDAAvailable on request
Cabometyx 40 mg tabletOralExelixisUS FDAAvailable on request
Cabometyx 60 mg tabletOralExelixisUS FDAAvailable on request
Cometriq 20 mg capsuleOralExelixisUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 29 November 2012Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Cabozantinib s-malate in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Cabozantinib s-malate available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Cabozantinib s-malate and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Cabozantinib s-malate have?

The catalogue lists 2 brand names for Cabozantinib s-malate, including Cabometyx, Cometriq.

Is Cabozantinib s-malate approved by the US FDA?

Yes. The US FDA first approved Cabozantinib s-malate on 29 November 2012, according to Drugs@FDA.

Does Cabozantinib s-malate need cold chain shipping?

No listed presentation of Cabozantinib s-malate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. COMETRIQ prescribing information (Exelixis). U.S. National Library of Medicine, DailyMed. Retrieved 18 October 2025

Request Cabozantinib s-malate for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.