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For certain adults with ccRCC at higher risk of cancer coming back after surgery

Taking KEYTRUDA or KEYTRUDA QLEX and WELIREG

ccRCC = renal cell carcinoma with a clear cell component, a type of kidney cancer.

What treatment may look like with KEYTRUDA or KEYTRUDA QLEX and WELIREG

KEYTRUDA or KEYTRUDA QLEX may be given for up to 1 year and WELIREG may be taken for a little over a year (54 weeks) or until your doctor decides it is time to stop treatment due to cancer coming back or certain side effects. Your doctor will recommend how long you should stay on these medicines based on your individual treatment plan. Explore this page to understand how each medicine is given and what your treatment schedule may include.

About KEYTRUDA

How do I take KEYTRUDA?

Your health care provider will administer KEYTRUDA into your vein through an intravenous (IV) line. Treatments are given over 30 minutes and usually take place at your doctor’s office or an infusion clinic.

Scheduling treatments with KEYTRUDA

  • When taken in combination with WELIREG as treatment after surgery for ccRCC, KEYTRUDA is usually given every 3 weeks or every 6 weeks depending on the dose that you are receiving.
  • KEYTRUDA may be given for up to 1 year or until your doctor decides it is time to stop treatment due to cancer coming back or certain side effects.
  • Talk to your doctor about the treatment schedule that is right for you. Your doctor can help answer questions.

30 minutes per intravenous infusion

Every 3 Weeks
Every 6 Weeks

Learn more about preparing for your first appointment taking KEYTRUDA

See how to prepare for your infusion

About KEYTRUDA QLEX

How do I take KEYTRUDA QLEX?

KEYTRUDA QLEX is an immunotherapy treatment given as a subcutaneous injection just under the skin by your health care provider in 1 minute* every 3 weeks or 2 minutes* every 6 weeks in the stomach area or thigh. Your dosing schedule depends on the treatment plan your doctor prescribes.

*Injection time only. Not total appointment time.

Scheduling treatments with KEYTRUDA QLEX

  • When taken in combination with WELIREG as treatment after surgery for ccRCC, KEYTRUDA QLEX is a subcutaneous injection given just under the skin by your health care provider in 1 minute* every 3 weeks or 2 minutes* every 6 weeks in the stomach area or thigh. Your dosing schedule depends on the treatment plan your doctor prescribes.

    *Injection time only. Not total appointment time.

  • KEYTRUDA QLEX may be given for up to 1 year or until your doctor decides it is time to stop treatment due to cancer coming back or certain side effects.
  • Talk to your doctor about the treatment schedule that is right for you. Your doctor can help answer questions.

KEYTRUDA QLEX is

Administered in 1 or 2 minutes* as an injection given just under the skin in the stomach area or thigh by a health care provider.

1-minute injection

Every 3 Weeks
OR

2-minute injection

Every 6 Weeks

*Injection time only. Not total appointment time.

Your doctor will decide how many treatments you need.

Learn more about preparing for your first appointment taking KEYTRUDA QLEX

See how to prepare for your injection

How can I track and talk about side effects with KEYTRUDA or KEYTRUDA QLEX?

During treatment, side effects can occur and should be treated as early as possible. In clinical trials with KEYTRUDA and KEYTRUDA QLEX, some patients stopped treatment due to side effects. Tell your doctor if you have any side effect that bothers you or that does not go away.

Find help navigating treatment for KEYTRUDA or KEYTRUDA QLEX

About WELIREG

Three WELIREG® (belzutifan) Tablets

Not actual size.

When taken in combination with KEYTRUDA or KEYTRUDA QLEX as treatment after surgery for ccRCC

The recommended dose of WELIREG is:

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

WELIREG may be taken for up to 54 weeks or until your doctor decides it is time to stop treatment due to cancer coming back or certain side effects.

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.

How can I track and talk about side effects with WELIREG?

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

Find help navigating treatment for WELIREG

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.

You also might be interested in:

WELIREG is a prescription medicine used to treat a type of kidney cancer called renal cell carcinoma with a clear cell component (ccRCC) in adults, with the medicine KEYTRUDA or KEYTRUDA QLEX, who are at intermediate-high or high risk of kidney cancer coming back after surgery to:

  • remove all or part of the kidney, or
  • remove all or part of the kidney and also surgery to remove cancer that has spread to other parts of the body (metastatic lesions).

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

It is not known if KEYTRUDA and KEYTRUDA QLEX are safe and effective for this use in children.

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 when taken with KEYTRUDA in adults with ccRCC include:

  • low red blood cell counts
  • increased blood liver enzymes (liver function tests)
  • tiredness
  • decreased white blood cell counts

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.

Do not receive KEYTRUDA QLEX if you are allergic to berahyaluronidase, hyaluronidase or any of the inactive ingredients in KEYTRUDA QLEX.

KEYTRUDA and KEYTRUDA QLEX are medicines that may treat certain cancers by working with your immune system. KEYTRUDA and KEYTRUDA QLEX can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen any time during treatment or even after your treatment has ended.

Call or see your health care provider right away if you develop any signs or symptoms of the following problems or if they get worse. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA or KEYTRUDA QLEX:

Lung problems: cough, shortness of breath, or chest pain.

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); or bleeding or bruising more easily than normal.

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.

Kidney problems: decrease in the amount of your urine; blood in your urine; swelling of your ankles; loss of appetite.

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes.

Problems can also happen in other organs and tissues. Signs and symptoms of these problems may include: chest pain; irregular heartbeat; shortness of breath; swelling of ankles; confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs; double vision; blurry vision; sensitivity to light; eye pain; changes in eyesight; persistent or severe muscle pain or weakness; muscle cramps; low red blood cells; bruising.

Infusion, injection-related, and allergic reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion, injection-related, and allergic reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, and back pain.

Rejection of a transplanted organ or tissue. Your health care provider should tell you what signs and symptoms you should report and they will monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA or KEYTRUDA QLEX. Your health care provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your health care provider will check you for these problems during treatment with KEYTRUDA or KEYTRUDA QLEX. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment with KEYTRUDA and KEYTRUDA QLEX if you have severe side effects.

Before you receive KEYTRUDA or KEYTRUDA QLEX, tell your health care provider if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ or tissue transplant, including corneal transplant, or have had or plan to have a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic); have had radiation treatment in your chest area; have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

If you are pregnant or plan to become pregnant, tell your health care provider. KEYTRUDA and KEYTRUDA QLEX can harm your unborn baby. If you are able to become pregnant, you will be given a pregnancy test before you start treatment. Use effective birth control during treatment with KEYTRUDA or KEYTRUDA QLEX and for 4 months after your last dose of KEYTRUDA or KEYTRUDA QLEX. Tell them right away if you think you may be pregnant or you become pregnant during treatment with KEYTRUDA or KEYTRUDA QLEX.

Tell your health care provider if you are breastfeeding or plan to breastfeed. It is not known if KEYTRUDA or KEYTRUDA QLEX passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA or KEYTRUDA QLEX and for 4 months after your last dose of KEYTRUDA or KEYTRUDA QLEX.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of KEYTRUDA QLEX when given with certain chemotherapy medicines include nausea; tiredness; and muscle, bone, and joint pain.

The most common side effects observed with KEYTRUDA when given with WELIREG, which may be experienced with KEYTRUDA QLEX, include low red blood cell count, increased blood liver enzymes, feeling tired, and decreased white blood cell counts.

These are not all the possible side effects of KEYTRUDA or KEYTRUDA QLEX. Talk to 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 KEYTRUDA and discuss it with your doctor. The physician Prescribing Information also is available.

Please read the accompanying Medication Guide for KEYTRUDA QLEX and discuss it with your doctor. The physician Prescribing Information also is available.

FDA-Approved Indication

WELIREG is a prescription medicine used to treat a type of kidney cancer called renal cell carcinoma with a clear cell component (ccRCC) in adults, with the medicine KEYTRUDA or KEYTRUDA QLEX, who are at intermediate-high or high risk of kidney cancer coming back after surgery to:

  • remove all or part of the kidney, or
  • remove all or part of the kidney and also surgery to remove cancer that has spread to other parts of the body (metastatic lesions).

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

It is not known if KEYTRUDA and KEYTRUDA QLEX are safe and effective for this use in children.

Important Safety Information for WELIREG

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 when taken with KEYTRUDA in adults with ccRCC include:

  • low red blood cell counts
  • increased blood liver enzymes (liver function tests)
  • tiredness
  • decreased white blood cell counts

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.

Important Safety Information for KEYTRUDA and KEYTRUDA QLEX

Do not receive KEYTRUDA QLEX if you are allergic to berahyaluronidase, hyaluronidase or any of the inactive ingredients in KEYTRUDA QLEX.

KEYTRUDA and KEYTRUDA QLEX are medicines that may treat certain cancers by working with your immune system. KEYTRUDA and KEYTRUDA QLEX can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen any time during treatment or even after your treatment has ended.

Call or see your health care provider right away if you develop any signs or symptoms of the following problems or if they get worse. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA or KEYTRUDA QLEX:

Lung problems: cough, shortness of breath, or chest pain.

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); or bleeding or bruising more easily than normal.

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.

Kidney problems: decrease in the amount of your urine; blood in your urine; swelling of your ankles; loss of appetite.

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes.

Problems can also happen in other organs and tissues. Signs and symptoms of these problems may include: chest pain; irregular heartbeat; shortness of breath; swelling of ankles; confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs; double vision; blurry vision; sensitivity to light; eye pain; changes in eyesight; persistent or severe muscle pain or weakness; muscle cramps; low red blood cells; bruising.

Infusion, injection-related, and allergic reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion, injection-related, and allergic reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, and back pain.

Rejection of a transplanted organ or tissue. Your health care provider should tell you what signs and symptoms you should report and they will monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA or KEYTRUDA QLEX. Your health care provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your health care provider will check you for these problems during treatment with KEYTRUDA or KEYTRUDA QLEX. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment with KEYTRUDA and KEYTRUDA QLEX if you have severe side effects.

Before you receive KEYTRUDA or KEYTRUDA QLEX, tell your health care provider if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ or tissue transplant, including corneal transplant, or have had or plan to have a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic); have had radiation treatment in your chest area; have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

If you are pregnant or plan to become pregnant, tell your health care provider. KEYTRUDA and KEYTRUDA QLEX can harm your unborn baby. If you are able to become pregnant, you will be given a pregnancy test before you start treatment. Use effective birth control during treatment with KEYTRUDA or KEYTRUDA QLEX and for 4 months after your last dose of KEYTRUDA or KEYTRUDA QLEX. Tell them right away if you think you may be pregnant or you become pregnant during treatment with KEYTRUDA or KEYTRUDA QLEX.

Tell your health care provider if you are breastfeeding or plan to breastfeed. It is not known if KEYTRUDA or KEYTRUDA QLEX passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA or KEYTRUDA QLEX and for 4 months after your last dose of KEYTRUDA or KEYTRUDA QLEX.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of KEYTRUDA QLEX when given with certain chemotherapy medicines include nausea; tiredness; and muscle, bone, and joint pain.

The most common side effects observed with KEYTRUDA when given with WELIREG, which may be experienced with KEYTRUDA QLEX, include low red blood cell count, increased blood liver enzymes, feeling tired, and decreased white blood cell counts.

These are not all the possible side effects of KEYTRUDA or KEYTRUDA QLEX. Talk to 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 KEYTRUDA and discuss it with your doctor. The physician Prescribing Information also is available.

Please read the accompanying Medication Guide for KEYTRUDA QLEX and discuss it with your doctor. The physician Prescribing Information also is available.