Cabometyx

The recommended dose of cabozantinib is **60 mg taken by mouth, once daily. **This medication needs to be taken on an empty stomach. Take it one hour before eating or two hours after eating. Swallow the tablets whole. Do not chew or crush the tablets.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. **If your doctor has recommended a dose different from the ones listed here, **do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

20 mg
Each yellow, film-coated, round tablet with no score, debossed with "XL" on one side and "20 " on the other side of the tablet, contains 20 mg of cabozantinib as cabozantinib (S)-maleate. *Nonmedicinal ingredients: *colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, iron oxide yellow, lactose anhydrous, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

40 mg
Each yellow, film-coated, triangle tablet with no score, debossed with "XL" on one side and "40" on the other side of the tablet, contains 40 mg of cabozantinib as cabozantinib (S)-maleate. *Nonmedicinal ingredients: *colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, iron oxide yellow, lactose anhydrous, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

60 mg
Each yellow, film-coated, oval tablet with no score, debossed with "XL" on one side and "60" on the other side of the tablet, contains 60 mg of cabozantinib as cabozantinib (S)-maleate. *Nonmedicinal ingredients: *colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, iron oxide yellow, lactose anhydrous, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Do not take this medication if you are allergic to cabozantinib or any ingredients of the medication.

**Many medications can cause side effects. **A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changed sense of taste

• constipation

• cough

• decreased appetite

• diarrhea

• dizziness

• dry mouth

• dry skin

• fatigue

• hair loss

• hand-foot skin reaction (e.g., redness, blisters, and pain on the palms of hands or soles of feet)

• headache

• heartburn

• hoarseness

• mouth sores or mouth pain

• muscle spasms

• nausea

• pain in arms, legs, and joints

• ringing in the ears

• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, lack of coordination, thirst, confusion)

• stomach pain

• trouble sleeping

• vomiting

• weakness

• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• dehydration (e.g., headache, thirst, loss of appetite, tiredness, weakness, dark or decreased urine)

• difficulty speaking

• fainting

• fever

• fluid build-up in the abdomen (e.g., rapid weight gain, abdominal pain, shortness of breath)

• high blood pressure (e.g., headache, vision changes, nausea, vomiting)

• low levels of calcium in the blood (e.g., numbness and tingling in the hands, feet or lips; muscle cramping; muscle spasms; light-headedness; slow heartbeat)

• numbness in the hands or feet

• rash or skin redness

• shortness of breath

• signs of anemia (e.g., fatigue, pale skin, shortness of breath, loss of energy, weakness)

• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)

• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (chest pain, coughing up blood, shortness of breath)

• signs of decreased thyroid function (e.g., constipation, dry skin, tiredness, weight gain, sensitive to the cold)

• signs of fluid build-up around the lungs (e.g., chest pain, cough, hiccups, rapid breathing)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• signs of low electrolyte levels (e.g., muscle spasms or weakness, tingling or numbness, tiredness, twitching, or memory loss)

• swelling in the hands, feet, or face

• symptoms of bone damage in the jaw (e.g., mouth, teeth or jaw pain; swelling or sores inside the mouth; numbness or feeling of heaviness in the jaw; loosening tooth)

• symptoms of decreased adrenal gland function (e.g., fatigue, darkened skin colour, low blood pressure with dizziness or fainting, muscle and joint pain, salt craving)

• symptoms of a fistula (e.g., anal bleeding, pain with bowel movements, fever, chills, foul smelling discharge from the anus)

• symptoms of irregular heartbeat (e.g., chest pain; dizziness; rapid, pounding heartbeat; shortness of breath)

• symptoms of sinus infection or cold (e.g., facial pain, nasal congestion, headache, sore throat)

• symptoms of inflammation of the thyroid gland (e.g., feelings of worry, irritability, anxiety, trouble sleeping, fatigue, weight loss, increased appetite, tremor)

• symptoms of pneumonia (e.g., fever or chills, shortness of breath, fatigue, chest pain, cough)

• symptoms of an overactive thyroid gland (e.g., anxiety; nervousness; weight loss; frequent and loose bowel movements; breathlessness; flushing; rapid, fluttering or pounding heart)

• wounds that do not heal

Stop taking the medication and seek immediate medical attention if any of the following occur:

• aneurysm (weakened blood vessel; cough, coughing up blood, sharp unexpected pain, hoarseness, unusual sensation in chest or abdomen)

• decreased brain function due to liver problems (e.g., change in alertness, confusion, mood or personality changes, changes in sleep, loss of consciousness)

• seizures

• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

• signs of reversible posterior leukoencephalopathy syndrome (e.g., headache, seizures, weakness, confusion, high blood pressure, vision changes, difficulty thinking clearly)

• signs of stroke (e.g., sudden or severe headache, sudden loss of coordination, vision changes, sudden slurring of speech, or unexplained weakness, numbness, or pain in arm or leg)

• symptoms of severely increased blood pressure (e.g., chest pain, blurred vision, dizziness, excessive tiredness, headache, stronger or faster heartbeat)

• symptoms of blood clot in the lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)

• symptoms of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)

• symptoms of a tear in the stomach or intestinal wall (e.g., abdominal pain, nausea, vomiting, constipation, fever)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: Cabozantinib may cause a heart rhythm problem called QT prolongation*.* If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, heart attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

**Birth control: If you or your partner is of childbearing age, it is important that you use **effective birth control, to avoid possible harm to the baby. Birth control should be used while taking cabozantinib and for at least 4 months after the last dose. If you become pregnant while taking this medication, contact your doctor immediately.

**Bleeding: **Cabozantinib may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. If you have a history of severe bleeding, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Blood clots: **This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg or lungs. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Decreased heart rate: This medication can cause decreased heart rate. If you have a low heart rate or experience symptoms of a low heart rate, such as fatigue, dizziness, or confusion contact your doctor.

Drowsiness/reduced alertness: Cabozantinib may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Fluid and electrolyte balance: Cabozantinib may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking this medication. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking this medication.

**Gastrointestinal perforation and fistula: **Cabozantinib has been reported to cause perforations (holes) and fistulas (abnormal connections) in the stomach or intestines. People who have medical conditions affecting the stomach or bowel, such as Crohn's disease or diverticulitis, or previous stomach surgeries may be more likely to experience a tear in the lining of the stomach, which can cause serious bleeding. This can occur without abdominal pain.

If you notice bloody or black and tarry stools, or vomit blood or material that looks like coffee grounds, seek medical help immediately.

Grapefruit juice: Grapefruit and grapefruit juice affect how cabozantinib is removed from the body. Consuming grapefruit products can cause too much of the medication to build up in the body and cause possibly harmful side effects. Do not drink grapefruit juice or eat grapefruit at any time while taking this medication for treatment.

**High blood pressure: **Cabozantinib can cause blood pressure to increase; possibly to a life-threatening level. If you have high blood pressure, it should be well controlled before starting to take cabozantinib. If your blood pressure is not controlled while taking cabozantinib, your doctor may have you stop taking this medication. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: As well as killing cancer cells, cabozantinib can reduce the number of cells that fight infection in the body (white blood cells).

If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.

**Liver function: **Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. Cabozantinib may also reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Deterioration of the jawbone: People who are taking cabozantinib may, although rarely, develop osteonecrosis of the jaw (deterioration of the jawbone). If you experience any pain, swelling, or infection of the jaw, report this to your doctor. Before starting treatment with cabozantinib, your doctor may recommend that you see a dentist for an examination and any necessary dental treatment.

**Reversible Posterior Leukoencephalopathy Syndrome (RPLS): **This is a rare disease of the brain that may occur when using medications like cabozantinib. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness, or consciousness or vision changes, contact your doctor immediately.

**Surgery: **This medication can cause wounds to take longer to heal. If you have surgery scheduled, including dental surgery, it may be necessary to stop taking this medication for 28 days before the surgery. Make sure all members of your health care team are aware that you are taking cabozantinib and talk to your doctor about whether you should stop this medication before surgery.

**Thyroid disease: **This medication may affect thyroid gland function. If you have problems with your thyroid gland, cabozantinib may make these problems worse. If you have a history of thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: The use of cabozantinib may cause harm to the developing baby if it is taken during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Contraception should be used by both the person taking this medication and their partner during the period that this medication is being taken and for at least 4 months after treatment. If oral contraceptives are used, other contraceptives like a condom or other barrier method should be used.

Breast-feeding: It is not known if cabozantinib passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Breast-feeding should be avoided while taking cabozantinib and for 4 months after the last dose of medication. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between cabozantinib and any of the following:

• ambrisentan

• aliskiren

• apalutamide

• apixaban

• aprepitant

• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)

• birth control

• bisphosphonates (e.g., alendronate, etidronate, risedronate)

• bosentan

• cholestyramine

• cobicistat

• colchicine

• dabigatran

• danazol

• desmopressin

• digoxin

• diltiazem

• diuretics (water pills; e.g., furosemide)

• dronedarone

• emtricitabine

• enzalutamide

• fexofenadine

• grapefruit juice

• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)

• HIV nucleotide reverse transcriptase inhibitors (NRTIs; e.g., abacavir, adefovir, lamivudine)

• HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)

• letermovir

• lumacaftor and ivacaftor

• macrolide antibiotics (e.g., clarithromycin, erythromycin)

• maraviroc

• mifepristone

• modafinil

• nirmatrelvir

• probenecid

• other protein kinase inhibitors (e.g., crizotinib, dabrafenib, idelalisib, imatinib, nilotinib)

• rifabutin

• rifampin

• saxagliptin

• seizure medications (e.g., carbamazepine, eslicarbazepine, phenytoin, phenobarbital, primidone)

• sitagliptin

• St. John’s wort

• tenofovir

• testosterone

• verapamil

• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Cabometyx