Taking CABOMETYX™ (cabozantinib)

Important Safety Information

What is CABOMETYX™?

CABOMETYX is a prescription medicine used to treat people with advanced kidney cancer (renal cell carcinoma) whose cancer has spread or grown after treatment with other cancer medications.
It is not known if CABOMETYX is safe and effective in children.

What are the possible side effects of CABOMETYX?

CABOMETYX may cause serious side effects, including:

• Severe bleeding (hemorrhage). Tell your healthcare provider right away if you have any signs of bleeding during treatment with CABOMETYX, including:
  • coughing up blood or blood clots
  • vomiting blood or if your vomit looks like coffee grounds
  • red or black (looks like tar) stools
  • menstrual bleeding that is heavier than normal
  • any unusual or heavy bleeding
• A tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you have tenderness or pain in your stomach area (abdomen).
• Blood clots, stroke, heart attack, and chest pain. 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 face, arm, or leg, especially on one side of your body
  • sudden confusion, trouble speaking, or understanding
  • sudden trouble seeing in one or both eyes
  • sudden trouble walking
  • dizziness, loss of balance or coordination
  • a sudden severe headache
• High blood pressure (hypertension). Hypertension is common with CABOMETYX and sometimes can be severe. Your healthcare provider will check your blood pressure before starting CABOMETYX and during treatment with CABOMETYX. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure.
• Diarrhea. Diarrhea is common with CABOMETYX and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away if you have frequent loose, watery bowel movements.
• A skin problem called hand-foot skin reaction. Hand-foot skin reactions are common and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen during treatment with CABOMETYX. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with CABOMETYX if you have certain side effects.

The most common side effects of CABOMETYX are:

• tiredness
• nausea
• decreased appetite
• vomiting
• weight loss
• constipation

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of CABOMETYX. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you take CABOMETYX, tell your healthcare provider about all of your medical conditions, including if you:

• have any unusual bleeding
• have high blood pressure
• Plan to have any surgery, including dental surgery. You should stop treatment with CABOMETYX at least 28 days before any scheduled surgery.
• Have liver problems
• Are pregnant, or plan to become pregnant. CABOMETYX can harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment and for 4 months after your final dose of CABOMETYX. Talk to your healthcare provider about birth control methods that may be right for you. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
• Are breastfeeding or plan to breastfeed. It is not known if CABOMETYX passes into your breast milk. Do not breastfeed during treatment and for 4 months after your final dose of CABOMETYX.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. CABOMETYX and certain other medicines may affect each other, causing side effects.

What should I avoid while taking CABOMETYX?
Do not drink grapefruit juice, eat grapefruit or supplements that contain grapefruit during treatment with CABOMETYX.

Please see the Patient Information in the accompanying full Prescribing Information.

You may report side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.