CABOZANTINIB-S-MALATE

Cometriq (cabozantinib) is a kinase inhibitor that interferes with the growth of some cancer cells.

Cometriq is a prescription medicine used to treat thyroid cancer that has spread to other parts of the body.

The Cabometyx brand of cabozantinib is used to treat advanced kidney cancer and liver cancer in people who have been previously treated with sorafenib (Nexavar).

Cabometyx (cabozantinib) is a kinase inhibitor, a type of enzyme inhibitor that blocks the action of certain protein kinases.

HOW CABOZANTINIB-S-MALATE IS GIVEN

• Cabozantinib is a pill, taken by mouth.
• Take cabozantinib on an empty stomach. Do not eat for at least 2 hours before and at least 1 hour after taking cabozantinib.
• You should not drink grapefruit juice or eat grapefruit during treatment with cabozantinib. It may change the amount of cabozantinib in your blood.
• Take cabozantinib exactly as prescribed.
• Swallow cabozantinib capsules whole with at least 8 ounces of water. Do not crush, dissolve or open capsules.
• Do not change your dose or stop cabozantinib unless your health care provider tells you to.
• If you miss a dose and your next dose is due in:
• In less than 12 hours, take your next dose at the normal time. Do not make up the next dose.
• 12 hours or more, take the missed dose as soon as you remember. Take your next dose at the normal time.
• Do not take more than 1 dose of cabozantinib at one time. Call your healthcare provider right away if you take too much.
• The amount of cabozantinib that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

SIDE EFFECTS

Get emergency medical help if you have signs of an allergic reaction to Cabozantinib: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Cabozantinib may cause a perforation (a hole or tear) or a fistula (an abnormal passageway) within your stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears;
• vomiting, diarrhea, or constipation that are severe and ongoing;
• swelling in your hands, arms, legs, or feet;
• easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding, or any bleeding that will not stop);
• bloody or tarry stools, cough with bloody mucus or vomit that looks like coffee grounds;
• jaundice (yellowing of the skin or eyes);
• pain, blisters, bleeding, or severe rash in the palms of your hands or the soles of your feet;
• confusion, thinking problems, weakness, vision changes, seizure;
• a light-headed feeling, like you, might pass out;
• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
• adrenal gland problems – nausea, vomiting, extreme tiredness, dizziness, weakness, fainting; or
• signs of a stroke or blood clot – sudden numbness or weakness on one side of your body, problems with vision or balance, trouble speaking or understanding what is said to you, chest pain, trouble breathing, swelling, or pain in an arm or leg.

Your future doses of Cabozantinib may be delayed or permanently discontinued if you have certain side effects.

Common Cabozantinib side effects may include:

• stomach pain, nausea, vomiting, loss of appetite, diarrhea, constipation;
• pain, redness, swelling, or sores in your mouth or throat;
• trouble speaking, changes in taste;
• cold symptoms such as stuffy nose, sneezing, sore throat, cough;
• rash;
• pain in your muscles, bones, and joints;
• abnormal liver function tests or other blood tests;
• feeling tired;
• weight loss; or
• hair color turning lighter.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

DOSAGE

Usual Adult Dose for Thyroid Cancer:-

Capsules:-

140 mg orally once a day until the patient no longer experiences clinical benefit or unacceptable toxicity occurs

Use:-

For progressive metastatic medullary thyroid cancer (MTC)

Usual Adult Dose for Renal Cell Carcinoma:-

Tablets:-

• As a single agent: 60 mg orally once a day until the patient no longer experiences clinical benefit or unacceptable toxicity occurs
• In combination with nivolumab: 40 mg once a day until disease progression or unacceptable toxicity

Comment:-

When administering this drug in combination with nivolumab, refer to the nivolumab prescribing information.

Uses:-

• For patients with advanced renal cell carcinoma (RCC)
• In combination with nivolumab, indicated for the first-line treatment of patients with advanced RCC

Usual Adult Dose for Hepatocellular Carcinoma:-

Tablets:-

60 mg orally once a day until the patient no longer experiences clinical benefit or unacceptable toxicity occurs

Use:-

• For patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

PRECAUTIONS

• Before starting cabozantinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking cabozantinib.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (cabozantinib may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Do not conceive a child (get pregnant) while taking cabozantinib. Barrier methods of contraception, such as condoms, are recommended during treatment and for 4 months after treatment is complete. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breastfeed while taking this medication.
• You should not drink grapefruit juice or eat grapefruit during your treatment with cabozantinib. It may make the amount of cabozantinib in your blood increase to a harmful level.

SELF-CARE TIPS

• Drink at least two to three quarts of fluid every 24 hours unless you are instructed otherwise.
• You may be at risk of infection, so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• Monitor your blood pressure and notify your physician if blood pressure is elevated or if you develop a severe headache, lightheadedness, or other neurological symptoms (numbness, tingling, difficulty speaking).
• To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Follow a regimen of anti-diarrhea medication as prescribed by your health care professional.
• Eat foods that may help reduce diarrhea 
• Prevention of hand-foot syndrome. Modification of normal activities of daily living to reduce friction and heat exposure to hands and feet for about a week after treatment.
• Keep palms of hands and soles of feet moist using emollients.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• Maintain physical activity as tolerated.
• If you experience symptoms or side effects, be sure to discuss them with your healthcare team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.