Generic drug: cabozantinib
Brand name: Cabometyx
What is Cabometyx (cabozantinib), and how does it work?
Cabometyx (cabozantinib) is a prescription medicine used to treat people with:
- advanced kidney cancer (renal cell carcinoma)
- liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.
It is not known if Cabometyx is safe and effective in children.
What are the side effects of Cabometyx?
Cabometyx may cause serious side effects, including:
- bleeding (hemorrhage). Cabometyx can cause severe bleeding that may lead to death. Tell your healthcare provider right away if you get any signs of bleeding during treatment with Cabometyx, including:
- a tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2parts of your body (fistula). Tell your healthcare provider right away if you get tenderness or pain in your stomach-area (abdomen).
- blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you get:
- swelling or pain in your arms or legs
- shortness of breath
- feel lightheaded or faint
- sweating more than usual
- numbness or weakness of your face, arm or leg, especially on one side of your body
- sudden confusion, trouble speaking or understanding
- sudden trouble seeing in one or both eyes
- sudden trouble walking
- dizziness, loss of balance or coordination
- a sudden severe headache
- high blood pressure (hypertension). Hypertension is common with Cabometyx and sometimes can be severe. Your healthcare provider will check your blood pressure before starting Cabometyx and during treatment with Cabometyx. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure.
- diarrhea. Diarrhea is common with Cabometyx and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away, if you have frequent loose, watery bowel movements.
- a skin problem called hand-foot skin reaction. Hand-foot skin reactions are common and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
- protein in your urine and possible kidney problems. Symptoms may include swelling in your hands, arms, legs, or feet.
- severe jaw bone problems (osteonecrosis). Symptoms may include jaw pain, toothache, or sores on your gums. Your healthcare provider should examine your mouth before you start and during treatment with Cabometyx. Tell your dentist that you are taking Cabometyx. It is important for you to practice good mouth care during treatment with Cabometyx.
- wound healing problems. Wound healing problems have happened in some people who take
Cabometyx. Tell your healthcare provider if you plan to have any surgery before or during treatment with
- You should stop taking Cabometyx at least 3 weeks before planned surgery.
- Your healthcare provider should tell you when you may start taking Cabometyx again after surgery.
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen during treatment with Cabometyx. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.
- Cabometyx may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Cabometyx if you have certain side effects.
The most common side effects of Cabometyx include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Cabometyx. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Cabometyx?
Important Dosage Information
- Stop treatment with Cabometyx at least 3 weeks prior to scheduled surgery, including dental surgery.
- Do not substitute Cabometyx tablets with cabozantinib capsules.
- Do not administer Cabometyx with food. Administer at least 1 hour before or at least 2 hours after eating.
- Swallow Cabometyx tablets whole. Do not crush Cabometyx tablets.
- Do not take a missed dose within 12 hours of the next dose.
- Modify the dose for certain patients with hepatic impairment and for patients taking drugs known to strongly induce or inhibit CYP450.
Recommended Dosage For Renal Cell Carcinoma
The recommended dosage of Cabometyx as a single agent is 60 mg once daily without food until the patient no longer experiences clinical benefit or experiences unacceptable toxicity.
The recommended dosage of Cabometyx in combination with nivolumab is provided in the following table:
Table 1: Recommended Dosage of Cabometyx in Combination with Nivolumab
|Recommended Dosage||Duration of Therapy|
|Cabometyx 40 mg once daily without food||until disease progression or unacceptable toxicity|
|Nivolumab 240 mg every 2 weeks (30-minute intravenous infusion) or 480 mg every 4 weeks (30-minute intravenous infusion)||until disease progression or unacceptable toxicity for up to 2 years|
Recommended Dosage For Hepatocellular Carcinoma
The recommended dosage of Cabometyx is 60 mg once daily without food until disease progression or unacceptable toxicity.
Dosage Modifications For Adverse Reactions
Withhold Cabometyx for:
- Intolerable Grade 2 adverse reactions
- Grade 3 or 4 adverse reactions
- Osteonecrosis of the jaw
Upon resolution/improvement (i.e., return to baseline or resolution to Grade 1) of an adverse reaction, reduce the dose as follows:
Table 2: Recommended Dosage Reductions for Cabometyx for Adverse Reactions
|Recommended Dosage||First Dosage Reduction To||Second Dosage Reduction To|
|Cabometyx 60 mg daily||40 mg daily||20 mg daily*|
|Cabometyx 40 mg daily in combination with nivolumab||20 mg daily||20 mg every other day*|
|* If previously receiving lowest dose, resume at same dose. If lowest dose not tolerated, discontinue Cabometyx.|
Permanently discontinue Cabometyx for any of the following:
- Severe hemorrhage
- Development of gastrointestinal (GI) perforation or Grade 4 fistula
- Acute myocardial infarction or arterial or venous thromboembolic events that require medical intervention
- Severe hypertension that cannot be controlled with anti-hypertensive therapy or hypertensive crisis
- Nephrotic syndrome
- Reversible posterior leukoencephalopathy syndrome
The following table represents dosage modifications that are different from those described above for Cabometyx or in the Full Prescribing Information for the drug administered in combination:
Table 3: Recommended Specific Dosage Modifications for Hepatic Adverse Reactions for Combination
|Cabometyx in combination with nivolumab||ALT or AST >3 times ULN but ≤10 times ULN with concurrent total bilirubin <2 times ULN||Withholda both Cabometyx and nivolumab until adverse reactions recoverb to Grades 0 or 1|
|ALT or AST >10 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN||Permanently discontinue both Cabometyx and nivolumab|
|a Consider corticosteroid therapy for hepatic adverse reactions if
Cabometyx is withheld or discontinued when administered in combination with nivolumab|
b After recovery, rechallenge with one or both of Cabometyx and nivolumab may be considered. If rechallenging with nivolumab with or without Cabometyx, refer to nivolumab Prescribing Information.
When administering Cabometyx in combination with nivolumab for the treatment of advanced RCC, refer to the nivolumab prescribing information.
Dosage Modifications For Coadministration With Strong CYP3A4 Inhibitors
- Reduce the daily Cabometyx dose by 20 mg (for example, from 60 mg to 40 mg daily or from 40 mg to 20 mg daily). Resume the dose that was used prior to initiating the strong CYP3A4 inhibitor 2 to 3 days after discontinuation of the strong inhibitor.
Dosage Modifications For Coadministration With Strong CYP3A4 Inducers
- Increase the daily Cabometyx dose by 20 mg (for example, from 60 mg to 80 mg daily or from 40 mg to 60 mg daily) as tolerated. Resume the dose that was used prior to initiating the strong CYP3A4 inducer 2 to 3 days after discontinuation of the strong inducer. Do not exceed a daily dose of 80 mg.
Dosage Modifications For Patients With Moderate And Severe Hepatic Impairment
- Reduce the starting dose of Cabometyx to 40 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Avoid Cabometyx in patients with severe hepatic impairment (Child-Pugh C).
What drugs interact with Cabometyx?
Effects Of Other Drugs On Cabometyx
Strong CYP3A4 Inhibitors
- Coadministration of a cabozantinib capsule formulation with a strong CYP3A4 inhibitor increased the exposure of cabozantinib, which may increase the risk of exposure-related adverse reactions. Avoid coadministration of Cabometyx with strong CYP3A4 inhibitors.
- Reduce the dosage of Cabometyx if coadministration with strong CYP3A4 inhibitors cannot be avoided.
- Avoid grapefruit or grapefruit juice which may also increase exposure of cabozantinib.
Strong CYP3A Inducers
- Coadministration of a cabozantinib capsule formulation with a strong CYP3A4 inducer decreased the exposure of cabozantinib, which may reduce efficacy.
- Avoid coadministration of Cabometyx with strong CYP3A4 inducers. Increase the dosage of Cabometyx if coadministration with strong CYP3A4 inducers cannot be avoided. Avoid St. John's wort which may also decrease exposure of cabozantinib.
Is Cabometyx safe to use while pregnant or breastfeeding?
- Based on findings from animal studies and its mechanism of action, Cabometyx can cause fetal harm when administered to a pregnant woman.
- There are no available data in pregnant women to inform the drug-associated risk.
- There is no information regarding the presence of cabozantinib or its metabolites in human milk, or their effects on the breastfed child or milk production.
- Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Cabometyx and for 4 months after the final dose.
Cabometyx (cabozantinib) is a prescription medicine used to treat people with advanced kidney cancer (renal cell carcinoma) and liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib. Serious side effects of Cabometyx include bleeding (hemorrhage), a tear in your stomach or intestinal wall or fistula, blood clots, stroke, heart attack, chest pain. and others.
Multimedia: Slideshows, Images & Quizzes
Ways to Keep Your Kidneys Healthy
You might know that more than a drink or two a day is bad for your health. But in some cases, any alcohol at all may not be a...
Picture of Liver
Front View of the Liver. The liver is a large, meaty organ that sits on the right side of the belly. See a picture of the Liver...
Picture of Kidneys
The kidneys are a pair of organs located in the back of the abdomen. See a picture of the Kidneys and learn more about the health...
Related Disease Conditions
Liver (Anatomy and Function)
The liver is the largest gland and organ in the body. There are a variety of liver diseases caused by liver inflammation, scarring of the liver, infection of the liver, gallstones, cancer, toxins, genetic diseases, and blood flow problems. Symptoms of liver disease generally do not occur until the liver disease is advanced. Some symptoms of liver disease include jaundice, nausea and vomiting, easy bruising, bleeding excessively, fatigue, weakness, weight loss, shortness of breath, leg swelling, impotence, and confusion. Treatment of diseases of the liver depends on the cause.
Second Source article from Government
Liver cancer is cancer of the liver cells (hepatocellular carcinoma) or of the ducts in the liver (cholangiocarcinoma). Liver cancer often arises due to liver damage, cirrhosis (scarring) caused by alcohol use/abuse, hepatitis B, or hepatitis C. Liver cancer may not cause any symptoms. Liver cancer is diagnosed with blood tests, imaging tests, and a liver biopsy. Treatment for liver cancer may include surgery, ablation, embolization, radiation, chemotherapy, and targeted therapy.
What Does Pain From Liver Cancer Feel Like?
Liver cancer may not cause any signs or symptoms in its initial stages. When the cancer begins to show its signs and symptoms, you may feel pain in the abdomen, particularly at the top right.
Signs of a Kidney Disease
Most of the signs of kidney diseases are unnoticed, ignored, or appear very late in the disease. Over 37 million American adults have kidney diseases, and most are not aware of it.
Pain From Liver Cancer
Patients suffering from liver cancer usually complain of a throbbing or stabbing sensation in the upper right side of the abdomen or the back of the shoulder. There may or may not be a swelling that doesn’t subside. The pain may be severe; it is graded 7/10 in intensity. Some patients may not have any symptoms in the early stages of liver cancer.
Is Kidney Cancer Curable?
Kidney cancer is an uncontrolled division of cells (cancer) that begins in the kidney. How curable is a particular cancer depends on its stage, its cell type, and the stage at which it is diagnosed.
Can You Live Without a Liver?
The liver is a vital organ regulating the levels of many substances in the body. It excretes a substance called bile. The bile helps in carrying away the waste from the liver. The blood from the digestive system (stomach and bowel) passes through the liver.
What Are the Early Signs of Kidney Cancer?
Kidney cancer or renal cell carcinoma is an abnormal growth of kidney cells. The most common and early sign of kidney cancer is blood in the urine or hematuria.
How Is Liver Cancer Usually Diagnosed?
The liver is the second largest organ (the first being the skin) in the human body. One blood test used to help diagnose liver cancer is the tumor marker alpha-fetoprotein (AFP), but it is not specific to liver cancer.
How Can You Detect Liver Cancer Early?
It is often hard to detect liver cancer at early stages because they do not present any symptoms until they are advanced. Small liver tumors are difficult to identify during a physical examination because most of the liver is covered by the rib cage.
What Is the Main Cause of Liver Cancer?
The exact cause of liver cancer is not known. Researchers have revealed that liver cancer occurs when the cells in the liver grow uncontrollably because of an abnormal change in their genetic material (mutation).
How Serious Is a Liver Biopsy?
A liver biopsy can be performed in an outpatient setting. In the hands of an experienced doctor, it rarely produces complications. Mild pain in the upper right abdomen that goes away within a few hours is the most common complication of a liver biopsy.
How Do You Get Liver Cancer?
The exact reason why you might get liver cancer is unknown. Chronic liver disease is often associated with primary liver cancer (cancer that starts in the liver).
What Are the Symptoms of Stage I Liver Cancer?
Liver cancer, hepatic cancer or hepatocellular cancer (HCC) is a cancer that begins in the liver. Normal liver cells become abnormal in appearance and behavior and grow out of control.
Treatment & Diagnosis
Medications & Supplements
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.