Belzutifan (bel-ZUE-ti-fan)

Treats von Hippel-Lindau (VHL) disease.

Brand Name(s):

Welireg

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• Swallow the tablet whole. Do not break, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how belzutifan works. Tell your doctor if you are using midazolam or birth control pills.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who 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.
• Do not breastfeed during treatment with this medicine and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or anemia.
• This medicine may cause the following problems:
  • Severe anemia, which may require blood transfusion
  • Severe hypoxia (low oxygen levels)
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred or other changes in vision, headache, pounding in the ears, slow or fast heartbeat
• Confusion, dizziness, trouble breathing
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, nausea, stomach pain
• Muscle or joint pain
• Stuffy or runny nose
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088