Cabometyx

Oral Administration

Do not substitute Cabometyx tablets and Cometriq capsules for one another

Take on empty stomach, do not eat for at least 2 hr before or 1 hr after administration

Swallow capsule or tablet whole; do not chew or empty contents of capsule; do not crush tablet

Do not take a missed dose within 12 hr of the next dose

Do not ingest foods (eg, grapefruit, grapefruit juice) or nutritional supplements known to affect CYP3A4 substrates (eg, St. John’s wort)

Before you take Cabometyx, tell your healthcare provider if you:

• are allergic to Cabometyx or to any of its ingredients 
• have high blood pressure
• have a recent history of coughing up blood or bleeding or any unusual bleeding
• have had recent surgery or plan to have surgery or a dental procedure
• have liver problems
• have any other medical conditions
• are pregnant or you or your partner plan to become pregnant.
• are breastfeeding or plan to breastfeed. 

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.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on how this medication works, it is expected to cause harm to a fetus (unborn baby) if exposed to Cabometyx. Talk to your healthcare provider if you are pregnant or if you or your partner plan to become pregnant.

If you are a female who is able to become pregnant, or are a male whose female partner is able to become pregnant; you should use effective birth control during your treatment with Cabometyx and for at least 4 months after your last dose of Cabometyx. Talk to your healthcare provider about birth control methods to prevent pregnancy while you are taking Cabometyx.

Tell your healthcare provider right away if you or your female partner becomes pregnant while taking Cabometyx.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your liver function

The recommended dose to treat kidney cancer is 60 mg by mouth once daily. 

Cabozantinib can increase your risk of serious bleeding. Stop using cabozantinib and call your doctor at once if you have severe stomach pain, bloody or tarry stools, coughing up blood, or any heavy or unusual bleeding.

Some people taking cabozantinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the 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.

You should not use cabozantinib if you are allergic to it.

To make sure cabozantinib is safe for you, tell your doctor if you have:

• high blood pressure;

• liver disease;

• an open wound or sore on your skin;

• a bleeding or blood-clotting disorder;

• a pre-existing dental problem;

• if you have recently had surgery or dental work; or

• if you have recently had any unusual or heavy bleeding.

Cabozantinib can harm an unborn baby.

• If you are a woman, do not take cabozantinib if you are pregnant.

• If you are a man, use effective birth control if your sexual partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is taking cabozantinib.

• Use birth control to prevent pregnancy while you are receiving cabozantinib, whether you are a man or a woman. Keep using birth control for at least 4 months after treatment ends.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking cabozantinib.

It is not known whether cabozantinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine, and for at least 4 months after your last dose.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Sweating a lot.
• Trouble walking.
• Shortness of breath.
• Very bad belly pain.
• Coughing, gagging, or choking (mainly when eating or drinking).
• Very loose stools (diarrhea).
• Loose stools (diarrhea) that will not go away.
• Feeling very tired or weak.
• A big weight loss.
• Skin wound that will not heal.
• Jaw pain.
• Very bad mouth irritation.
• Mouth sores.
• Not able to pass urine or change in how much urine is passed.
• Redness or irritation of the palms of hands or soles of feet.
• Trouble swallowing.
• A burning, numbness, or tingling feeling that is not normal.

Cabometyx is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

None.

One case of overdosage was reported in the cabozantinib clinical program; a patient inadvertently took twice the intended dose (200 mg daily) of another formulation of cabozantinib product for nine days. The patient suffered Grade 3 memory impairment, Grade 3 mental status changes, Grade 3 cognitive disturbance, Grade 2 weight loss, and Grade 1 increase in BUN. The extent of recovery was not documented.

Cabometyx tablets are supplied as follows:

60 mg tables are yellow film-coated, oval shaped with no score, debossed with "XL" on one side and "60" on the other side of the tablet; available in bottles of 30 tablets:
NDC 42388-023-26

40 mg tablets are yellow film-coated, triangle shaped with no score, debossed with "XL" on one side and "40" on the other side of the tablet; available in bottles of 30 tablets:
NDC 42388-025-26

20 mg tablets are yellow film-coated, round shaped with no score, debossed with "XL" on one side and "20" on the other side of the tablet; available in bottles of 30 tablets:
NDC 42388-024-26

Store Cabometyx at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Breastfeeding is not recommended during use of this drug, and for at least 4 months after treatment completion. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.