Description and Brand Names

US Brand Name

1. Cabometyx
2. Cometriq

Descriptions

Cabozantinib capsule is used to treat medullary thyroid cancer that has already spread to different parts of the body.

Cabozantinib tablet is used alone to treat advanced kidney cancer. It is also used in combination with nivolumab as first-line treatment for advanced kidney cancer.

Cabozantinib tablet is also used to treat a type of liver cancer, called hepatocellular carcinoma, in patients who have been previously treated with other medicines (eg, sorafenib).

Cabozantinib tablet is also used to treat differentiated thyroid cancer that has already spread to different parts of the body, in patients who can no longer be treated with radioactive iodine or not able to receive radioactive iodine, and have been previously treated with other medicines (eg, VEGFR-targeted treatment) but did not work well.

Cabozantinib is an antineoplastic (cancer) medicine. It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

• Capsule
• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of cabozantinib in children younger than 12 years of age to treat differentiated thyroid cancer or in children to treat medullary thyroid cancer, liver cancer, and advanced kidney cancer. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cabozantinib tablets in the elderly.

Appropriate studies have not been performed on the relationship of age to the effects of cabozantinib capsules in the geriatric population. However, no geriatric-specific problems have been documented to date.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Apalutamide
• Avacopan
• Boceprevir
• Carbamazepine
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Enzalutamide
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Lumacaftor
• Mavacamten
• Mitotane
• Nefazodone
• Nelfinavir
• Netupitant
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Rifampin
• Ritonavir
• Saquinavir
• St John’s Wort
• Telaprevir
• Telithromycin
• Voriconazole
• Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Blood clots or
• Heart attack, acute or
• Hypertension (high blood pressure), uncontrolled or
• Hypocalcemia (low calcium levels in the blood) or
• Hypothyroidism or
• Proteinuria (protein in the urine) or
• Stomach fistula or perforation (a hole in the stomach) or
• Stroke, recent—Use with caution. May make these conditions worse.

• Dental or tooth problems or
• Dental procedures or surgery or
• Poor oral hygiene or
• Tooth infection—May increase risk for severe jaw problems.

• Hematemesis (vomiting of blood), recent or
• Hemoptysis (coughing up blood), recent or
• Hemorrhage (severe bleeding), recent history or
• Melena (black, tarry stools)—Should not be used in patients with these conditions.

• Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use is not recommended in patients with these conditions.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before taking this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Do not substitute Cabometyx® tablets with cabozantinib capsules. Do not substitute Cometriq® capsules with cabozantinib tablets.

Take this medicine on an empty stomach. Do not eat for at least 2 hours before and at least 1 hour after taking this medicine.

Swallow the medicine whole with a full glass (at least 8 ounces) of water. Do not crush, break, chew, or open the capsule or tablet.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may increase the amount of this medicine in the blood.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For thyroid cancer:
    • Adults—140 milligrams (mg) (one 80 mg and three 20 mg capsules) per day as a single dose. Your doctor may adjust the dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For advanced kidney cancer:
    • Adults—60 milligrams (mg) once a day. Your doctor may adjust the dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For advanced kidney cancer in combination with nivolumab:
    • Adults—40 milligrams (mg) once a day. Your doctor may adjust the dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For hepatocellular carcinoma:
    • Adults—60 milligrams (mg) once a day. Your doctor may adjust the dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For thyroid cancer:
    • Adults and children 12 years of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor.
      • BSA of 1.2 meter squared (m2) or more—60 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
      • BSA of less than 1.2 m2—40 mg once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

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.

If you miss a dose of this medicine and it is less than 12 hours until your next scheduled dose, skip the missed dose and take your next dose at the normal time. If you miss a dose and it is more than 12 hours until your next dose, take it as soon as possible and take your next dose at the normal time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

1. Blurred vision
2. burning, numbness, tingling, or painful sensations
3. confusion
4. constipation
5. dark urine
6. darkening of the skin
7. decreased urination
8. diarrhea
9. difficulty with breathing or swallowing
10. dizziness
11. dry mouth
12. dry skin and hair
13. fainting
14. feeling cold
15. hair loss
16. headache
17. hoarseness or husky voice
18. increase in heart rate
19. lightheadedness
20. loss of appetite
21. mental depression
22. muscle cramps, spasms, and stiffness
23. nausea or vomiting
24. nervousness
25. pain in the chest, groin, or legs, especially the calves
26. pounding in the ears
27. rapid breathing
28. redness, swelling, or pain of the skin
29. scaling of the skin on the hands and feet
30. severe, sudden headache
31. skin rash or ulcers
32. slow or fast heartbeat
33. slurred speech
34. stomach pain
35. sudden loss of coordination
36. sudden, severe weakness or numbness in the arm or leg
37. sunken eyes
38. thirst
39. unsteadiness or awkwardness
40. unusual tiredness or weakness
41. vision changes
42. weakness in the arms, hands, legs, or feet
43. weight gain
44. wrinkled skin
45. yellow eyes or skin

Less common

1. Bleeding gums
2. bloody, black, or tarry stools
3. coughing up blood
4. heartburn
5. heavy jaw feeling
6. increased menstrual flow or vaginal bleeding
7. indigestion
8. loosening of a tooth
9. mood or mental changes
10. muscle cramps in the hands, arms, feet, legs, or face
11. nosebleeds
12. numbness and tingling around the mouth, fingertips, or feet
13. pain, swelling, or numbness in the mouth or jaw
14. paralysis
15. prolonged bleeding from cuts
16. red or dark brown urine
17. seizures
18. severe stomach pain, cramping, or burning
19. tremor
20. trouble breathing
21. vomiting of material that looks like coffee grounds, severe and continuing

Rare

1. Disturbed color perception
2. double vision
3. halos around lights
4. night blindness
5. overbright appearance of lights
6. tunnel vision

Incidence not known

1. Cloudy or bloody urine
2. high blood pressure
3. swelling of the face, feet, or lower legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

1. Belching
2. bleeding after defecation
3. change in taste
4. changes in hair color
5. decreased appetite
6. decreased weight
7. difficulty having a bowel movement
8. difficulty with moving
9. fear
10. lack or loss of strength
11. loss of taste
12. muscle pain
13. pain in the joints
14. rash
15. sore throat
16. stomach discomfort, upset, or pain
17. swelling or inflammation of the mouth
18. uncomfortable swelling around the anus
19. voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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