Class: Biological Therapy

Generic Name: cabozantinib

Trade Name: Cabometyx™

How is this drug used? Cabometyx is indicated for patients with advanced renal cell carcinoma (RCC) who have already been treated with prior anti-angiogenic therapy.

What is the mechanism of action? Cabometyx is a kinase inhibitor that binds to certain protein receptors on cells known as MET, AXL, and VEGFR-1, -2, and -3. These receptors may play a role in how tumors grow and spread in the body. By binding to these receptors, Cabometyx may stop tumors from growing.

How is Cabometyx given (administered)? Cabometyx is administered orally. Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking Cabometyx.

How are patients monitored?  Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Cabometyx. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Cabometyx?

• Fatigue
• Nausea
• Decreased appetite
• Vomiting
• Weight loss
• Constipation

What are some of the less common but potentially serious side effects of Cabometyx?

• Hemorrhage
• GI perforations and fistulas
• Thrombotic events such as heart attack, stroke, or other serious arterial events
• Extremely high blood pressure
• Severe diarrhea
• Palmer-plantar erythrodysesthesia syndrome (pain and/or blisters on hands and feet)

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

Are there any special precautions patients should be aware of before starting treatment?

• Females should be advised of the potential risk to a fetus and to use effective contraception during treatment and for at least four months after the final dose of Cabometyx. Breastfeeding is also to be avoided in the same time frame.
• Tell your doctor about any medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Tell your doctor about any planned surgeries, including dental surgery.
• Tell your doctor if you have high blood pressure, liver problems, or any unusual bleeding.
• Do not ingest foods (e.g., grapefruit, grapefruit juice) or nutritional supplements that are known to inhibit cytochrome P450 during Cabometyx treatment.

When should patients notify their physician?

Contact your healthcare professional immediately in case of any of the following:

• Signs or symptoms of unusual bleeding (hemorrhage).
• If you have pain or tenderness in your stomach area.
• At the first sign of loose stool or increased frequency of bowel movements.
• For an intolerable rash on hands or feet.
• For significant weight loss.

Get emergency help right away if you have:

• Swelling or pain in your arms or legs.
• Shortness of breath.
• Feel lightheaded or faint.
• Sweating more than usual.
• Numbness or weakness of your arm, face, or leg, especially on one side of your body.
• Sudden confusion.
• Sudden trouble seeing.
• Sudden trouble walking.
• Sudden, severe headache.

These symptoms could be a sign of heart attack, stroke, or RPLS (due to edema in the brain).

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 09/16.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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