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Certain von Hippel-Lindau (VHL) disease-related tumors

Taking WELIREG

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WELIREG is a convenient once-daily oral medicine

Read below for some general information about taking WELIREG. Please talk to your doctor about your individual prescription needs.

Three WELIREG® (belzutifan) Tablets

Not actual size.

The recommended dose of WELIREG in adult patients is:

Three 40-mg pills (120 mg) taken by mouth at the same time each day. You may take WELIREG with or without food.

Do not stop taking WELIREG or change your dose without talking to your health care provider.

How should I take WELIREG?

Take WELIREG exactly as your health care provider tells you. Do not stop taking WELIREG or change your dose without talking to your health care provider.

If you have certain side effects, your health care provider may change your dose or stop treatment temporarily or permanently.

Take your prescribed dose of WELIREG 1 time a day, at the same time each day, with or without food.

Swallow WELIREG tablets whole. Do not chew, crush, or split WELIREG tablets.

If you miss a dose of WELIREG, take it as soon as possible on the same day. Then take your next dose of WELIREG at your regular time the next day. Do not take extra tablets to make up for the missed dose.

If you vomit after taking a dose of WELIREG, do not take an extra dose. Take your next dose at your regular time the next day.

If you take too much WELIREG, call your health care provider or go to the nearest emergency room right away.

When adding WELIREG to a daily routine, consider setting a reminder on your phone or watch to stay on track and remember to take your medicine at the same time each day.

Talk to your doctor about what to expect from your treatment with WELIREG

Everyone responds differently to treatment

WELIREG may take time to show results, so it’s important to stick with your treatment plan. Talk to your doctor about what you may expect when taking WELIREG and before making any changes to how you take your medicine.

You may have side effects from WELIREG, so pay attention to how you’re feeling

It’s important to record how you’re feeling each day and to keep your health care team informed if there are any changes to your health. 

Your doctor may reduce, pause, or stop your treatment with WELIREG

Your health care provider may choose to adjust your WELIREG dose during treatment. Do not change your dose or stop taking your medication on your own.

If you have side effects that are not well controlled or become serious, your health care team may decide to pause treatment for some time or stop your WELIREG treatment altogether. 

Talk to your doctor before making changes

Remember, do not change your dose or stop taking your medication on your own. It’s important to continue taking WELIREG as prescribed throughout your treatment. If you have any questions or concerns, talk to your doctor.

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WELIREG is a prescription medicine used to treat von Hippel-Lindau (VHL) disease in adults who need treatment for a type of kidney cancer called renal cell carcinoma (RCC), tumors in the brain and spinal cord called central nervous system (CNS) hemangioblastomas, or a type of pancreatic cancer called pancreatic neuroendocrine tumors (pNET), that do not need surgery right away.

It is not known if WELIREG is safe and effective in children with VHL.

WELIREG can cause serious side effects. WELIREG can cause harm to your unborn baby.

  • A pregnancy test will be done before you start treatment.
  • Birth control methods that contain hormones may not work as well during treatment.
  • Females and males with female partners who can become pregnant should use an effective form of non-hormonal birth control (contraception) during treatment and for 1 week after your last dose.

WELIREG can cause serious side effects, including:

Low red blood cell counts (anemia). Low red blood cell counts can be severe. You may need a blood transfusion if your red blood cell counts drop too low. Your health care provider will do blood tests to check your red blood cell counts before you start and during treatment with WELIREG. Tell your health care provider if you get any symptoms of low red blood cell counts, including tiredness, feeling cold, shortness of breath, chest pain, or fast heartbeat.

Low oxygen levels in your body. WELIREG can cause low oxygen levels in your body that can be severe and may require you to stop treatment with WELIREG, receive oxygen therapy, or be hospitalized. Your health care provider will monitor your oxygen levels before you start and during treatment with WELIREG. Tell your health care provider or get medical help right away if you get symptoms of low oxygen in your body, including shortness of breath or increased heart rate.

Harm to your unborn baby. Treatment with WELIREG during pregnancy can cause harm to your unborn baby.

Females who are able to become pregnant:

  • Your health care provider will do a pregnancy test before you start treatment with WELIREG.
  • You should use an effective form of non-hormonal birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal system patches) may not work as well during treatment with WELIREG.
  • Talk to your health care provider about birth control methods that may be right for you during treatment with WELIREG.
  • Tell your health care provider right away if you become pregnant or think you may be pregnant during treatment with WELIREG.

Males with female partners who are able to become pregnant:

  • You should use effective birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Tell your health care provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking WELIREG.

Before taking WELIREG, tell your health care provider about all of your medical conditions, including if you:

  • have low red blood cell counts (anemia)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if WELIREG passes into your breast milk. Do not breastfeed during treatment with WELIREG and for 1 week after your last dose.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking WELIREG with certain other medicines can affect each other and cause serious side effects and may affect the way certain other medicines work.

The most common side effects of WELIREG in adults with VHL disease include:

  • low red blood cell counts
  • tiredness
  • increased blood creatinine (kidney function test)
  • headache
  • dizziness
  • increased blood sugar (glucose) levels
  • nausea

The most common side effects of WELIREG when taken alone in adults with advanced ccRCC include:

  • low red blood cell counts
  • tiredness
  • muscle and joint pain
  • increased blood creatinine (kidney function test)
  • decreased white blood cell counts
  • increased blood liver enzymes (liver function tests)
  • decreased blood salts (sodium) levels
  • increased blood potassium levels

Your health care provider may change your dose, temporarily stop, or permanently stop treatment with WELIREG if you get certain side effects.

WELIREG may cause fertility problems in males and females, which may affect your ability to have children. Talk to your health care provider if this is a concern for you.

These are not all of the possible side effects of WELIREG. Call your health care provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for WELIREG, including an important warning about harm to an unborn baby, and discuss it with your doctor. The physician Prescribing Information also is available.

Indication

WELIREG is a prescription medicine used to treat von Hippel-Lindau (VHL) disease in adults who need treatment for a type of kidney cancer called renal cell carcinoma (RCC), tumors in the brain and spinal cord called central nervous system (CNS) hemangioblastomas, or a type of pancreatic cancer called pancreatic neuroendocrine tumors (pNET), that do not need surgery right away.

It is not known if WELIREG is safe and effective in children with VHL.

Important Safety Information

WELIREG can cause serious side effects. WELIREG can cause harm to your unborn baby.

  • A pregnancy test will be done before you start treatment.
  • Birth control methods that contain hormones may not work as well during treatment.
  • Females and males with female partners who can become pregnant should use an effective form of non-hormonal birth control (contraception) during treatment and for 1 week after your last dose.

WELIREG can cause serious side effects, including:

Low red blood cell counts (anemia). Low red blood cell counts can be severe. You may need a blood transfusion if your red blood cell counts drop too low. Your health care provider will do blood tests to check your red blood cell counts before you start and during treatment with WELIREG. Tell your health care provider if you get any symptoms of low red blood cell counts, including tiredness, feeling cold, shortness of breath, chest pain, or fast heartbeat.

Low oxygen levels in your body. WELIREG can cause low oxygen levels in your body that can be severe and may require you to stop treatment with WELIREG, receive oxygen therapy, or be hospitalized. Your health care provider will monitor your oxygen levels before you start and during treatment with WELIREG. Tell your health care provider or get medical help right away if you get symptoms of low oxygen in your body, including shortness of breath or increased heart rate.

Harm to your unborn baby. Treatment with WELIREG during pregnancy can cause harm to your unborn baby.

Females who are able to become pregnant:

  • Your health care provider will do a pregnancy test before you start treatment with WELIREG.
  • You should use an effective form of non-hormonal birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal system patches) may not work as well during treatment with WELIREG.
  • Talk to your health care provider about birth control methods that may be right for you during treatment with WELIREG.
  • Tell your health care provider right away if you become pregnant or think you may be pregnant during treatment with WELIREG.

Males with female partners who are able to become pregnant:

  • You should use effective birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Tell your health care provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking WELIREG.

Before taking WELIREG, tell your health care provider about all of your medical conditions, including if you:

  • have low red blood cell counts (anemia)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if WELIREG passes into your breast milk. Do not breastfeed during treatment with WELIREG and for 1 week after your last dose.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking WELIREG with certain other medicines can affect each other and cause serious side effects and may affect the way certain other medicines work.

The most common side effects of WELIREG in adults with VHL disease include:

  • low red blood cell counts
  • tiredness
  • increased blood creatinine (kidney function test)
  • headache
  • dizziness
  • increased blood sugar (glucose) levels
  • nausea

The most common side effects of WELIREG when taken alone in adults with advanced ccRCC include:

  • low red blood cell counts
  • tiredness
  • muscle and joint pain
  • increased blood creatinine (kidney function test)
  • decreased white blood cell counts
  • increased blood liver enzymes (liver function tests)
  • decreased blood salts (sodium) levels
  • increased blood potassium levels

Your health care provider may change your dose, temporarily stop, or permanently stop treatment with WELIREG if you get certain side effects.

WELIREG may cause fertility problems in males and females, which may affect your ability to have children. Talk to your health care provider if this is a concern for you.

These are not all of the possible side effects of WELIREG. Call your health care provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for WELIREG, including an important warning about harm to an unborn baby, and discuss it with your doctor. The physician Prescribing Information also is available.