CABOMETYX 60 mg/1
cabozantinib · TABLET · Exelixis, Inc.
CABOMETYX is a tablet containing cabozantinib at 60 mg/1, taken oral. Manufactured by Exelixis, Inc..
Key Facts
- Brand Name
- CABOMETYX
- Generic Name
- cabozantinib
- NDC Code (Product)
42388-023- Manufacturer
- Exelixis, Inc.
- Strength
- 60 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA208692
- Marketing Start
- 04/25/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.2 ) adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible ( 1.3 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). ( 1.4 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). ( 1.4 ) 1.1 Renal Cell Carcinoma CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). CABOMETYX, in combination with nivolumab, is indicated for the first-line tre…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Do NOT substitute CABOMETYX tablets with cabozantinib capsules. ( 2.1 ) Administer on an empty stomach at least 1 hour before or at least 2 hours after eating. ( 2.2 ) Stop treatment with CABOMETYX at least 3 weeks prior to scheduled surgery, including dental surgery. ( 2.1 ) Recommended Dose: RCC (Single Agent): 60 mg orally, once daily. ( 2.2 ) RCC (Combination Therapy): 40 mg orally, once daily with: 240 mg nivolumab every 2 weeks by intravenous infusion; -OR- 480 mg nivolumab every 4 weeks by intravenous infusion; -OR- 600 mg nivolumab and 10,000 units hyaluronidase every 2 weeks administered subcutaneously; -OR- 1,200 mg nivolumab and 20,000 units hyaluronidase every 4 weeks administered subcutaneously. ( 2.2 ) HCC: 60 mg orally, once daily. ( 2.2 ) DTC, pNET, epNET Adult patients and pediatric patients 12 years of age and older with bodyweight greater than or equal to 40 kg: 60 mg orally once daily. ( 2.2 ) Pediatric patients 12 years of age and older with bodyweight less than 40 kg: 40 mg orally once daily. (2.2) 2.1 Important Dosage Information and Recommended Evaluation and Testing Before Initiating CABOMETYX Do not substitute CABOMETYX tablets …
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4 inhibitors: Reduce the CABOMETYX dosage if coadministration cannot be avoided. ( 2.4 , 7.1 ) Strong or moderate CYP3A4 inducers: Increase the CABOMETYX dosage if coadministration cannot be avoided. ( 2.5 , 7.1 ) 7.1 Effects of Other Drugs on CABOMETYX Strong CYP3A4 Inhibitors Coadministration of a cabozantinib capsule formulation with a strong CYP3A4 inhibitor increased the exposure of cabozantinib, which may increase the risk of exposure-related adverse reactions [see Clinical Pharmacology (12.3) ] . Avoid coadministration of CABOMETYX with strong CYP3A4 inhibitors. Reduce the dosage of CABOMETYX if coadministration with strong CYP3A4 inhibitors cannot be avoided [see Dosage and Administration (2.4) ] . Avoid grapefruit or grapefruit juice which may also increase exposure of cabozantinib. Strong or Moderate CYP3A Inducers Coadministration of a cabozantinib capsule formulation with a strong CYP3A4 inducer decreased the exposure of cabozantinib, which may reduce efficacy [see Clinical Pharmacology (12.3) ] . Avoid coadministration of CABOMETYX with strong or moderate CYP3A4 inducers. Increase the dosage of CABOMETYX if coadministration with strong o…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hemorrhage [see Warnings and Precautions (5.1) ] Perforations and Fistulas [see Warnings and Precautions (5.2) ] Thromboembolic Events [see Warnings and Precautions (5.3) ] Hypertension and Hypertensive Crisis [see Warnings and Precautions (5.4) ] Cardiac Failure [see Warnings and Precautions (5.5) ] Diarrhea [see Warnings and Precautions (5.6) ] Palmar-plantar Erythrodysesthesia [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Proteinuria [see Warnings and Precautions (5.10) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.11) ] Impaired Wound Healing [see Warnings and Precautions (5.12) ] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.13) ] Thyroid Dysfunction [see Warnings and Precautions (5.14) ] Hypocalcemia [see Warnings and Precautions (5.15) ] The most common (≥ 20%) adverse reactions are: as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, constipation.…
Frequently Asked Questions
What is CABOMETYX used for?
CABOMETYX contains cabozantinib. It is a tablet taken oral. Consult your doctor for specific uses.
Is CABOMETYX a controlled substance?
CABOMETYX is not classified as a controlled substance by the DEA.
What is the generic name for CABOMETYX?
The generic name for CABOMETYX is cabozantinib. There are 3 other brand versions of cabozantinib.
What is the NDC code for CABOMETYX 60 mg/1?
The NDC (National Drug Code) for CABOMETYX 60 mg/1 is 42388-023, listed by Exelixis, Inc..