Cabometyx

The active ingredient in Cabometyx is cabozantinib.

• Cabozantinib is a tyrosine kinase inhibitor (TKI) that targets several receptors involved in cancer cell growth, blood vessel formation, and metastasis. These include VEGFR, MET, AXL, and other pathways that tumors use to survive. By blocking these signals, Cabometyx:
• Slows down the growth of cancer cells.
• Reduces the formation of new blood vessels (angiogenesis).
• Limits cancer's spread to other parts of the body.

This multi-targeted approach makes Cabometyx useful for cancers that depend heavily on blood vessel development and aggressive cell signaling.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Cabometyx. However, the following is a synopsis of the general guidelines for the use of Cabometyx:

• Take Cabometyx once daily, exactly as prescribed.
• Swallow tablets whole with a glass of water.
• Take on an empty stomach, at least 1 hour before or 2 hours after eating.
• Avoid grapefruit and grapefruit juice, which may raise cabozantinib levels.
• Do not crush, chew, or split the tablets.
• If you miss a dose and it is less than 12 hours from your next scheduled dose, skip the missed dose. Do not take extra medication to make up for a missed dose.
• Your dosage may be adjusted based on side effects, blood pressure, or liver function results.
• Tell your healthcare provider about any planned dental or surgical procedures. Cabometyx can impair wound healing and increase the risk of complications.

Your healthcare provider may recommend additional medications to manage symptoms such as diarrhea, nausea, or high blood pressure during treatment.

Some mild or common side effects of Cabometyx seen in clinical trials as compared to placebo include:

• Diarrhea.
• Fatigue or lightheadedness.
• Nausea or vomiting.
• Decreased appetite.
• Constipation.
• Weight loss.
• High blood pressure.
• Dry skin.
• Mouth sores.
• Muscle spasms.
• Hair color changes.
• Joint or back pain.
• Weight gain.

Some individuals may experience serious side effects while using Cabometyx. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe bleeding, including vomiting blood, nosebleeds, or black stools.
• Blood clots, including pulmonary embolism or stroke symptoms.
• Chest pain or signs of a heart attack.
• Gastrointestinal perforation or fistula (severe abdominal pain, fever, swelling).
• Serious skin reactions or peeling skin.
• Liver problems such as jaundice or dark urine.
• Reversible posterior leukoencephalopathy syndrome (headache, confusion, vision changes).
• Worsening shortness of breath.
• Low calcium levels cause tingling, muscle cramping, or seizures.
• Hypothyroidism or symptoms of low thyroid function.
• Poor wound healing or wound reopening after a procedure.

These are not all of the possible side effects of Cabometyx. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Cabometyx, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• High blood pressure or heart disease.
• Liver cancer or kidney cancer.
• A history of stroke, blood clots, or pulmonary embolism.
• Hypertension (high blood pressure).
• Adrenal gland problems.
• Issues with wound healing, recent surgery, or dental procedures.
• Dental problems or planned dental work are associated with the risk of osteonecrosis of the jaw.
• Gastrointestinal disorders or previous bowel perforation.
• Hypothyroidism or a history of abnormal calcium levels.
• Neurological conditions affecting balance or nerve function.
• A history of major bleeding events.
• Recent infections or poor immune function.
• Your healthcare provider will likely check your blood pressure, liver function, thyroid levels, and calcium levels throughout treatment.

Cabometyx should not be used in individuals who:

• Have a known allergy to cabozantinib or any inactive ingredient in the tablets.
• Are unable to safely take oral tyrosine kinase inhibitors due to medical complications.
• Have severe bleeding disorders that cannot be controlled.
• Cannot stop interacting with medications that strongly affect CYP3A4 enzyme activity.

The timeline can vary depending on the type and stage of cancer being treated. Some patients may notice symptom improvement or tumor shrinkage within several weeks, while others may require a few months to see measurable results.

When Cabometyx is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir) – increase cabozantinib levels.
• Strong CYP3A4 inducers (rifampin, phenytoin, carbamazepine, St. John’s Wort) – reduce effectiveness.
• Blood thinners (warfarin, apixaban) – increased risk of bleeding.
• Blood pressure medications – levels may need adjustment.
• Other tyrosine kinase inhibitors – increased toxicity risk.
• Supplements affecting liver enzymes or clotting.
• Grapefruit juice – raises cabozantinib levels.
• Medications causing hypocalcemia.
• Drugs that increase bleeding risk, such as NSAIDs.
• Nivolumab.

Always review all prescription and nonprescription products with your healthcare provider before taking Cabometyx.

Cabometyx is available in tablet form in the following strengths:

20 mg

40 mg

60 mg

The 60 mg cabozantinib capsules are commonly used as a starting dose for adults, but dosing may be reduced depending on side effects, interactions, or overall tolerance.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store at room temperature and keep out of reach of children.

Cabometyx is manufactured by Exelixis, Inc., a biotechnology company specializing in targeted cancer therapies.

At this time, no generic version of Cabometyx (cabozantinib) is available. Only brand-name Cabometyx and the related capsule formulation Cometriq are on the market.

Do not stop taking Cabometyx without guidance from your healthcare provider. Stopping treatment suddenly may cause your cancer to progress more quickly.

If you experience severe or life-threatening side effects, contact your healthcare provider immediately. Your dose may be held, reduced, or discontinued depending on your condition.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Cabometyx can cause harm to an unborn baby in pregnant women, so effective contraception is required during treatment and for at least 4 months after your last dose.

Do not breastfeed while taking Cabometyx. The medication may pass into breast milk and cause serious adverse effects in a nursing infant. Ask your healthcare provider when it is safe to resume breastfeeding after treatment has ended.