KEYTRUDA is a prescription medicine used to treat a kind of bladder and urinary tract cancer called urothelial carcinoma. KEYTRUDA may be used with the medicine enfortumab vedotin in adults when your bladder or urinary tract cancer has spread or cannot be removed by surgery (advanced urothelial cancer), and you are not able to receive chemotherapy that contains the medicine cisplatin.

This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information for clinical benefit.

MAKING TREATMENT DECISIONS TOGETHER

Discussions with your doctor

Facing bladder cancer comes with many challenges, which may include having conversations with your doctor and health care team. Remember, though, while they are the experts on cancer and treatment, you are the expert on yourself, your goals, and how you’re feeling. This is all valuable information for your care team to take into consideration, and why it’s so important to be honest and open with them during your conversations.

There are many ways to work together with your doctor to take a more active role in treatment decisions:

  • Don’t be afraid to speak up. Ask questions about your treatment and don’t hesitate to let them know if anything isn’t clear.
  • Tell your care team about your treatment goals. Letting them know what is most important to you will help them make suggestions that are right for you.
  • Ask what resources are available to help you stay on treatment.
  • Bring a friend or family member to appointments. They can help with the conversation, make sure all your questions are answered, and take notes so you don’t have to. This way, you can focus your attention on what your doctor is saying and be assured the information is also captured for you to look at later.
  • Give a friend or family member the ability to talk to your doctor on your behalf with an advance health care directive.

Some questions to ask the care team:

  • Can you explain why you recommend this treatment option?
  • This medical term is confusing. Can you explain it to us?
  • What side effects of treatment should we expect?
  • Do you have any suggestions for dealing with this side effect?

Be sure to write down any questions you have before appointments and take notes during appointments.

Discussing cancer and treatment with loved ones

Bladder cancer and treatment can be difficult to talk about, even with the people you’re closest to. However, having those conversations can make you feel better. Opening up to your loved ones can also help them understand the support you need and make them feel more comfortable helping you with treatment decisions.

Remember to voice your treatment goals. Your loved ones want to help. Understanding what you want to get out of treatment makes it easier for them to help you. Be as open and honest as possible. Let your loved ones know your fears, concerns, and how you think they can support you. Also, try your best to consider what they say about treatment and any resources they think could help you. It can be hard to focus on these things sometimes, but your loved ones only want what is best for you.

For caregivers of someone facing cancer

Caring for someone with cancer, especially bladder cancer, is hard. It can be challenging to know how, when, or if it’s appropriate to offer support for making treatment decisions. Use the button below to find helpful information on how to care for a loved one with cancer.

Financial help

Questions about insurance coverage or financial assistance? We can help.

To speak to a Merck Access Program representative:

FDA-Approved Indication

KEYTRUDA is a prescription medicine used to treat a kind of bladder and urinary tract cancer called urothelial carcinoma. KEYTRUDA may be used with the medicine enfortumab vedotin in adults when your bladder or urinary tract cancer has spread or cannot be removed by surgery (advanced urothelial cancer), and you are not able to receive chemotherapy that contains the medicine cisplatin.

This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information for clinical benefit.

Important Safety Information

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA 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:

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 reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion 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. 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 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. 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. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects.

Before you receive KEYTRUDA, tell your health care provider if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ 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 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 and for 4 months after your last dose of KEYTRUDA. Tell them right away if you think you may be pregnant or you become pregnant during treatment with KEYTRUDA.

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

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

Common side effects of KEYTRUDA when given with enfortumab vedotin include rash; tingling or numbness of the arms or legs; feeling tired; hair loss; weight loss; diarrhea; itching; decreased appetite; nausea; changes in sense of taste; urinary tract infections; constipation; swelling of your arms, hands, legs, and feet; dry eye; dizziness; joint aches; and dry skin.

These are not all the possible side effects of KEYTRUDA. 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.