Tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. You or your partner should not become pregnant while you are taking belzutifan. You may be required to have a pregnancy test before starting treatment. You and/or your partner should use birth control during your treatment and for 1 week after your final dose. Belzutifan may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, or injections). You will need to use another method of birth control during your treatment. Ask your doctor to help you choose a method of birth control that will work for you or your partner. If you or your partner becomes pregnant while taking belzutifan, call your doctor immediately. Belzutifan may harm the fetus.
You will be given the Medication Guide when you begin treatment with belzutifan and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.Why is this medicine prescribed?
Belzutifan is used to treat renal cell carcinoma (RCC; kidney cancer), central nervous system (CNS) hemangioblastomas (tumors in the brain and spinal cord), and a certain type of pancreatic cancer in adults with von Hippel-Lindau disease (VHL; a rare disease that causes tumors and cysts). Belzutifan is also used to treat certain types of RCC and pheochromocytoma or paraganglioma (tumors on or around a small gland near the kidneys). Belzutifan is in a class of medications called hypoxia-inducible factor inhibitors. It works by blocking the activity of a certain protein in people with VHL.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Belzutifan comes as a tablet to take by mouth. Take once daily with or without food. Take belzutifan at around the same time every day.
Take belzutifan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
If you vomit after taking belzutifan, do not take another dose. Continue your regular dosing schedule on the next day.
Your doctor may temporarily or permanently stop your treatment or decrease your dose if you experience certain side effects. Tell your doctor how you are feeling during your treatment with belzutifan. Continue to take belzutifan even if you feel well. Do not stop taking belzutifan without talking to your doctor.
What special precautions should I follow?
Before taking belzutifan,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking belzutifan. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had anemia (a lower-than-normal number of red blood cells) or kidney or liver problems.
- tell your doctor if you are breastfeeding. You should not breast-feed while you are taking belzutifan and for 1 week after your final dose.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking belzutifan.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
Take the missed dose as soon as you remember it on the same day, then continue your regular dosing schedule the next day. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
- unusual bruising and bleeding
- shortness of breath or fast heartbeat
What side effects can this medicine cause?
Belzutifan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dizziness
- tiredness
- headache
- nausea, stomach pain, diarrhea, constipation
- joint, muscle, or bone pain
- muscle spasms or weakness
- vision changes
- weight gain
- fever, cough, or other signs of infection
- swelling of the arms, hands, feet, ankles, or lower legs
- numbness or tingling in the hands, legs, or feet
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- tiredness, feeling cold, pale skin, shortness of breath, chest pain, or fast heartbeat
- unusual bleeding or bruising
- slow, fast, or irregular heartbeat
Belzutifan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep the two desiccant (drying agent) canisters in the bottle of medication to keep the tablets dry. Do not eat the desiccant canisters.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to belzutifan.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.