Uses

This medication is used to treat people who have a certain inherited disorder (von Hippel-Lindau disease). People with this disease may form tumors and fluid-filled sacs (cysts) in many different parts of the body. Tumors may be either noncancerous or cancerous. This medication is not a cure for von Hippel-Lindau disease. It is used to help treat certain tumors/growths caused by this disease that do not need surgery right away (such as in the kidneys, pancreas, brain/spinal cord). Belzutifan works by slowing or stopping the growth of tumor cells.

How To Use

Read the Medication Guide provided by your pharmacist before you start taking belzutifan and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not chew, crush, or split the tablets. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you vomit after taking a dose, do not take another dose. Take your next dose at the regular time on the next day.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Nausea, dizziness, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• vision changes (such as blurred vision, decreased vision)

This medication commonly causes a decrease in red blood cells in your body (anemia) which can be severe. If your red blood cell counts drop too low, you may need a blood transfusion. Tell your doctor right away if you get symptoms of anemia such as unusual tiredness, feeling cold, shortness of breath, or fast heartbeat.

Belzutifan may cause low oxygen levels in your body. If low oxygen levels occur, your doctor may direct you to temporarily stop this medication, or prescribe oxygen treatment, or treat you in a hospital. Tell your doctor right away if you get symptoms of low oxygen such as shortness of breath or fast heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking belzutifan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blood disorders (such as anemia)

This drug may make you dizzy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

You should not become pregnant while using belzutifan. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication. (See also Warning section.)

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 week after the last dose is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include daridorexant, elacestrant, some hepatitis C drugs (such as asunaprevir, ombitasvir-paritaprevir-ritonavir), lonafarnib, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood counts, oxygen levels in your body) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember on the same day. If it is the next day when you remember, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Keep the drying agent (desiccant canisters) in the bottle. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.