Belzutifan Oral Tablets

What is this medication?

BELZUTIFAN (bel ZUE ti fan) targets proteins in cancer cells and stops the cancer cells from growing. It treats certain types of cancer from von Hippel-Lindau disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): WELIREG

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• low red blood cell counts
• an unusual or allergic reaction to belzutifan, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• birth control pills
• certain medicines for blood pressure
• certain medicines for depression, like citalopram or fluoxetine
• certain medicines for erectile dysfunction
• certain medicines for fungal infections like fluconazole, luliconazole, or voriconazole
• certain medicines for seizures like carbamazepine, eslicarbazepine, oxcarbazepine, topiramate, and valproic acid
• certain medicines for stomach problems like esomeprazole and omeprazole
• narcotic medicines for pain

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medicine may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your health care provider tells you to stop.

Birth control may not work properly while you are taking this medicine. Talk to your health care provider about using an extra method of birth control.

Do not become pregnant while taking this medicine or for 1 week after stopping it. Women must use a non-hormonal form of birth control while taking this medicine and for 1 week after stopping it. There is potential for serious harm to an unborn child. Tell your health care provider right away if you think you might be pregnant.

Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.

Males who get this medicine must use a condom during sex with females who can get pregnant. If you get a woman pregnant, there is potential for serious harm to an unborn child. You will need to continue wearing a condom for 1 week after stopping the medicine. Tell your health care provider right away if you think your partner might be pregnant.

This medicine may make it more difficult to get pregnant or father a child. Talk to your health care provider if you are concerned about your fertility.

Tell your health care provider right away if you have any change in your eyesight.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

This medicine can cause constipation. Talk to your health care provider if you have bowel movements less often than usual or if you have less than 3 bowel movements per week. Call if stool is hard or dry, or if you have trouble passing gas. Contact your provider right away if you have nausea, vomiting, or belly swelling or pain. Drink plenty of water.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• blurred vision OR changes in vision
• high blood sugar (increased hunger, thirst or urination; unusually weak or tired, blurry vision)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• low calcium levels (fast heartbeat; muscle cramps or pain; pain, tingling, or numbness in the hands or feet; seizures)
• low red blood cell counts (feeling faint; lightheaded, falls; unusually weak or tired)
• trouble breathing
• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• dizziness
• headache
• low phosphorous levels (loss of appetite, muscle weakness)
• muscle cramps, pain
• nausea
• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.