Belzutifan is used in people with von Hippel-Lindau disease (VHL), a rare genetic condition that can cause tumors to develop in certain organs of the body.

Belzutifan is for use in adults with VHL who need treatment for certain tumors of the kidneys, pancreas, or brain and spinal cord. Belzutifan is used when these tumors do not require surgery right away.

Belzutifan may also be used for purposes not listed in this medication guide.

Belzutifan can cause anemia (low red blood cells) or low oxygen levels. These conditions may need to be treated with blood transfusions, oxygen therapy, or hospitalization.

Call your doctor right away if you have pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet, fast heartbeats, or chest pain.

Belzutifan may harm an unborn baby. Both men and women using belzutifan should use effective non-hormonal birth control to prevent pregnancy while using belzutifan and for at least 1 week after the last dose.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking belzutifan, do not take another dose. Take your next dose as scheduled.

Belzutifan can cause anemia (low red blood cells) or low oxygen levels. These conditions may need to be treated with blood transfusions, oxygen therapy, or hospitalization.

You will need frequent medical tests, even if you have no symptoms.

Do not change your dose or stop using a medicine without your doctor's advice.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Von Hippel-Lindau Syndrome:

Recommended dose: 120 mg orally once daily until disease progression or unacceptable toxicity

Use: For treatment of adult patients with Von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Tell your doctor if you have ever had low red blood cells.

Both men and women using this medicine should use effective non-hormonal birth control to prevent pregnancy. Belzutifan can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs.

Belzutifan can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take two doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have:

• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet; or

• low oxygen levels--shortness of breath, chest pain, fast heartbeats.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of belzutifan may include:

• headache, dizziness, tiredness;

• nausea;

• increased blood sugar (increased thirst or urination, dry mouth, fruity breath); or

• abnormal kidney function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect belzutifan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.