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Molecule

Cabozantinib

Available on requestOrphanOncology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Cabozantinib is a prescription medicine indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). It is available as kits. MedsAcross supplies Cabozantinib 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

ATC classification
L01EX07 Cabozantinib · Cancer medicines (antineoplastics), subgroup L01E, subgroup L01EX
US FDA first approval
Approved
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Dosage forms
Kit
Identifiers
UNII 1C39JW444GRxCUI 1363268CAS 849217-68-1DrugBank DB08875Q795057

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

1 presentations of Cabozantinib, sorted by availability.

MedicineManufacturerRegisterAvailability
Cometriq kitExelixisUS FDAAvailable on request

Brands by market

1 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 FDAApprovedDrugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

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

Questions and answers

Is Cabozantinib available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Cabozantinib and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Cabozantinib have?

The catalogue lists 1 brand names for Cabozantinib, including Cometriq.

Is Cabozantinib authorised in the European Union?

Yes. Cabozantinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Cabozantinib need cold chain shipping?

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

Which ATC class is Cabozantinib in?

Cabozantinib is classified under ATC code L01EX07 (Cabozantinib).

References

  1. COMETRIQ prescribing information (Exelixis). U.S. National Library of Medicine, DailyMed. Retrieved 18 October 2025
  2. Cabometyx: European public assessment report (EPAR). European Medicines Agency. Retrieved 15 October 2026
  3. Cometriq: European public assessment report (EPAR). European Medicines Agency. Retrieved 13 October 2026

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