Cabozantinib

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Generic Name: Cabozantinib Brand Name(s): Generics only. No brands available.

Uses

What is Cabozantinib used for?

Cabozantinib is used to treat certain types of cancer (including kidney, thyroid cancer). Cabozantinib belongs to a class of drugs known as tyrosine kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How should I take Cabozantinib?

Since different forms of this medication (capsules, tablets) are used to treat different types of cancer, do not change forms of this medication unless directed by your doctor.

Take this medication by mouth as directed by your doctor, usually once daily. Do not take with food. Take it on an empty stomach. Do not eat for at least 2 hours before your dose and at least 1 hour after taking it.

Swallow this medication whole with a full glass of water (8 ounces/240 milliliters). Do not open or crush the capsules or tablets.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

How do I store Cabozantinib?

Cabozantinib is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Cabozantinib in the bathroom or the freezer. There may be different brands of Cabozantinib that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Cabozantinib down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Cabozantinib?

Before taking cabozantinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, recent bleeding (including recently coughing up blood), high blood pressure.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Cabozantinib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water. It may also be best to eat soft, moist foods.

Some people taking cabozantinib may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having any surgery (especially dental work), tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking cabozantinib at least 28 days before surgery. Follow all instructions about stopping or starting this medication.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using cabozantinib. Cabozantinib may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 4 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to a nursing infant, breast-feeding while using this drug and for 4 months after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Cabozantinib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Cabozantinib. Cabozantinib is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Cabozantinib?

Dizziness, diarrhea, nausea, vomiting, mouth sores, constipation, stomach pain, tiredness, weakness, weight loss, decreased appetite, taste changes, hoarseness, and lightening of hair color may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including: redness/pain/swelling/blisters on the palms of your hands or soles of your feet, frothy urine, swelling of the hands/feet, signs of a low calcium blood level (such as severe muscle spasms, mental/mood changes, seizures), symptoms of a jawbone problem (such as jaw pain, toothache, gum sores).

Cabozantinib may also rarely cause a serious brain condition. Get medical help right away if you develop headaches, seizures, vision changes, confusion, or problems thinking.

This medication may rarely cause serious problems (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism) from blood clots. Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of your body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling in your arms/legs, tingling/weakness/numbness in your face/arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Cabozantinib?

Other medications can affect the removal of cabozantinib from your body, which may affect how cabozantinib works. One example is St. John’s wort, among others.

Cabozantinib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Cabozantinib?

Cabozantinib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

What health conditions may interact with Cabozantinib?

Cabozantinib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Cabozantinib.

What is the dose of Cabozantinib for an adult?

Usual Adult Dose for Thyroid Cancer

140 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:

-Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking this drug.

-Advise patients the capsule form of this drug cannot be substituted with the tablet form of this drug.

Use: Treatment of progressive, metastatic medullary thyroid cancer (MTC).

Usual Adult Dose for Renal Cell Carcinoma

60 mg orally once a day

Duration of therapy: Until patient no longer experiences clinical benefit or unacceptable toxicity occurs.

Comments:

-Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking this drug.

-Advise patients the tablet form of this drug cannot be substituted with the capsule form of this drug.

Use: Treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Renal Dose Adjustments

-Mild to Moderate Renal Dysfunction: No adjustment recommended.

Liver Dose Adjustments

Capsule formulation (MTC):

-Mild to Moderate Hepatic Impairment: 80 mg orally once a day.

-Severe Hepatic Impairment: Not recommended.

Tablet formulation (RCC):

-Mild to Moderate Hepatic Impairment: 40 mg orally once a day.

-Severe Hepatic Impairment: Not recommended.

Dose Adjustments

Capsule formulation (MTC):

Adverse Reactions (NCI CTCAE Grade 4 Hematologic; Grade 3 or Greater Non-Hematologic; or Intolerable Grade 2): Withhold treatment until improvement of the adverse reaction to baseline or resolution to Grade 1; then adjust the dose as follows:

-If previous dose 140 mg/day: Reduce dose to 100 mg/day.

-If previous dose 100 mg/day: Reduce dose to 60 mg/day.

-If previous dose 60 mg/day: Do not dose reduce; resume at 60 mg/day if tolerated or discontinue the drug.

Concomitant Use of Strong CYP450 3A4 Inhibitors:

-Not recommended.

-If concomitant use is necessary, reduce the dose of this drug by 40 mg (e.g., from 140 mg/day to 100 mg/day).

-Resume the dose used prior to initiation of the strong CYP450 3A4 inhibitor 2 to 3 days after discontinuation of the 3A4 inhibitor.

Concomitant Use of Strong CYP450 3A4 Inducers:

-Not recommended if alternative therapy is available.

-If concomitant use is necessary, increase the dose of this drug by 40 mg (e.g., from 140 mg/day to 180 mg/day) as tolerated.

-Resume the dose used prior to initiation of the strong CYP450 3A4 inducer 2 to 3 days after discontinuation of the 3A4 inducer.

-Maximum Dose: 180 mg/day

Tablet formulation (RCC):

Scheduled Surgery: Stop treatment at least 28 days prior to scheduled surgery, including dental surgery.

Adverse Reactions (NCI CTCAE Grade 4, Grade 3, or Intolerable Grade 2): Withhold treatment until improvement of the adverse reaction to baseline or resolution to Grade 1; then adjust the dose as follows:

-If previous dose 60 mg/day: Reduce dose to 40 mg/day.

-If previous dose 40 mg/day: Reduce dose to 20 mg/day.

-If previous dose 20 mg/day: Do not dose reduce; resume at 20 mg/day if tolerated or discontinue the drug.

Concomitant Use of Strong CYP450 3A4 Inhibitors:

-Not recommended.

-If concomitant use is necessary, reduce the dose of this drug by 20 mg (e.g., from 60 mg/day to 40 mg/day).

-Resume the dose used prior to initiation of the strong CYP450 3A4 inhibitor 2 to 3 days after discontinuation of the 3A4 inhibitor.

Concomitant Use of Strong CYP450 3A4 Inducers:

-Not recommended if alternative therapy is available.

-If concomitant use is necessary, increase the dose of this drug by 20 mg (e.g., from 60 mg/day to 80 mg/day) as tolerated.

-Resume the dose used prior to initiation of the strong CYP450 3A4 inducer 2 to 3 days after discontinuation of the 3A4 inducer.

-Maximum Dose: 80 mg/day

Permanently Discontinue Treatment (either capsule or tablet formulation):

-Development of perforation or fistula formation;

-Severe hemorrhage;

-Arterial thromboembolic event (e.g., myocardial infarction, cerebral infarction);

-Nephrotic syndrome;

-Malignant hypertension, hypertensive crisis, severe hypertension despite optimal medical management;

-Osteonecrosis of the jaw;

-Reversible posterior leukoencephalopathy syndrome.

Other Comments

Administration Advice:

-Do not open/break/crush/chew tablets or capsules; swallow whole with a full glass of water.

-Do not take a missed dose if it is less than 12 hours before the next dose.

-Do not ingest foods (e.g., grapefruit) or nutritional supplements (e.g., St. John’s Wort) that are known to inhibit or induce CYP450 activity while taking this drug.

Storage Requirements:

-Store at 20 to 25 degrees Celsius (68 to 77 Fahrenheit).

-Keep in the original package to protect from moisture.

Monitoring:

-Cardiovascular: Blood pressure (prior to and regularly during treatment)

-Musculoskeletal: Oral exam (prior to and periodically during treatment due to ONJ risk)

-Renal: Urine protein (regularly during treatment)

Patient Advice:

-This drug may cause side effects such as dizziness that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.

What is the dose of Cabozantinib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Cabozantinib available?

Cabozantinib is available in the following dosage forms and strengths:

  • Oral capsule,
  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Cabozantinib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: June 4, 2018 | Last Modified: June 4, 2018

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