Description
Belzutifan is used to treat von Hippel-Lindau (VHL) disease in patients who need treatment for kidney cancer (renal cell carcinoma), brain and spinal cord tumors (CNS hemangioblastomas), or pancreatic cancer (pancreatic neuroendocrine tumor [pNET]) that do not require surgery right away.
Belzutifan is also used to treat kidney cancer (renal cell carcinoma) with a clear cell component that has spread after treatment with a programmed death-receptor-1 (PD-1) or programmed death-ligand-1 (PD-L1) inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) cancer medicines.
Belzutifan is also used to treat neuroendocrine tumors called pheochromocytoma or paraganglioma (PPGL) in patients that has spread to areas near the adrenal gland, cannot be removed by surgery, or that has spread throughout the body.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- 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 belzutifan in children to treat von Hippel-Lindau (VHL) disease and kidney cancer and in children younger than 12 years of age to treat neuroendocrine tumors. 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 belzutifan in the elderly.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Ranolazine
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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.
- Abemaciclib
- Acalabrutinib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfentanil
- Armodafinil
- Benzhydrocodone
- Bosutinib
- Cannabidiol
- Cariprazine
- Cenobamate
- Cholera Vaccine
- Cobimetinib
- Codeine
- Conivaptan
- Cyclosporine
- Dasatinib
- Desogestrel
- Dienogest
- Dihydrocodeine
- Diltiazem
- Dronedarone
- Drospirenone
- Ebola Zaire Vaccine, Live
- Entrectinib
- Esomeprazole
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Everolimus
- Fentanyl
- Fluconazole
- Fluoxetine
- Fluvoxamine
- Gestodene
- Hydrocodone
- Influenza Virus Vaccine, Live
- Levomethadyl
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Anemia—Use with caution. May make this condition worse.
Proper Use
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 side effects.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
Take this medicine at the same time each day, with or without food.
Swallow the tablet whole. Do not break, crush, or chew it.
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 (tablets):
- For the treatment of von Hippel-Lindau (VHL) disease and kidney cancer:
- Adults—120 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For the treatment of pheochromocytoma or paraganglioma (PPGL):
- Adults and children 12 years of age and older weighing 40 kilograms (kg) or more—120 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children 12 years of age and older weighing less than 40 kg—80 mg once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For the treatment of von Hippel-Lindau (VHL) disease and kidney cancer:
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 vomit after taking a dose, take the next dose at the regular 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.
Precautions
It is very important that a doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills. Female patients should use an effective form of birth control during treatment and for at least 1 week after the last dose. Male patients who have female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose to prevent pregnancy in a sexual partner. If a pregnancy occurs while using the medicine, tell your doctor right away.
This medicine may cause severe anemia, which may require blood transfusion. Check with your doctor right away if you have pale skin, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
Check with your doctor right away if you have confusion, dizziness, fast heartbeat, trouble breathing, or weakness. These may be symptoms of severe hypoxia (low oxygen levels).
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- Bleeding gums
- blurred vision
- change in vision
- chest tightness
- chills
- confusion
- cough
- coughing up blood
- diarrhea
- difficulty swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- headache
- hives, itching, skin rash
- increased menstrual flow or vaginal bleeding
- loss of taste or smell
- muscle or body aches
- nausea or vomiting
- nervousness
- nosebleeds
- pale skin
- paralysis
- pounding in the ears
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red or black, tarry stools
- red or dark brown urine
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
- sore throat
- sweating
- swelling
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
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
- Body pain
- constipation
- difficulty in moving
- ear congestion
- loss of voice
- muscle, cramps, pain, or stiffness
- pain in the joints
- sneezing
- sore throat
- stomach pain
- stuffy or runny nose
- swollen joints
- weight increased
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.
DRG-20520339
