Opdivo (nivolumab)

Reviewed by: HU Medical Review Board | Last reviewed: April 2023

Opdivo® (nivolumab) is an immunotherapy treatment option for some patients who have advanced or metastatic bladder cancer, as well as some patients where bladder cancer has been removed by surgery and are at high risk of the cancer returning. Patients receive treatment with nivolumab through an intravenous (IV) infusion.1

How does immunotherapy work?

Immunotherapy drugs work to treat cancer by affecting the way that a patient’s immune system functions to help it fight cancer cells more effectively. The immune system is a group of organs and cells that help protect a person’s body from infection and disease. In patients with cancer, the immune system works to target and attack cancer cells as well.1,2

How does nivolumab work?

Nivolumab is a type of immunotherapy drug called a PD-1 inhibitor, which is a type of treatment for certain forms of bladder cancer. PD-1 is a checkpoint protein present on T cells (immune system cells) that can attach to the PD-L1 protein on certain cancer cells and help disguise them from the immune system.

Because the immune system cannot detect and attack them, cancer cells can grow more easily when PD-1 is allowed to bind to PD-L1. Nivolumab works by binding to PD-1 and blocking its interaction with PD-L1 proteins, which helps the immune system to find and kill the cancer cells more effectively.

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Who can receive nivolumab?

Nivolumab may be used to treat certain patients who have bladder cancer that is advanced or metastatic, which means that the bladder cancer cells have spread beyond the bladder and/or to other parts of the body. It may also be used to help reduce the risk of bladder cancer returning in certain patients with bladder cancer that has been removed by surgery and is at high risk of returning.1,3

In advanced or metastatic bladder cancer, it may be used for some patients who have already tried treatment with platinum-based chemotherapy but the treatment did not work or is not working anymore. If you have bladder cancer, your healthcare provider can talk with you about the advantages and disadvantages of treatment with nivolumab.1,3

Reporting other health conditions

Nivolumab is not appropriate for every patient with bladder cancer. For example, your healthcare provider will need to know if you have other types of health conditions before prescribing nivolumab. These include:1,3

  • Immune system problems, including Crohn’s disease, ulcerative colitis, or lupus
  • Lung or breathing problems
  • Liver or kidney problems
  • Having had an organ transplant
  • Endocrine disorders such as diabetes or thyroid disorders

If you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed, talk with your doctor. Nivolumab can cause harm to a developing fetus and should not be given to people who are pregnant.1,3

While receiving nivolumab, use contraceptives during treatment and for a period of time after completing treatment (patients should discuss appropriate birth control methods, and how long they need to use them, with their doctor). Do not breastfeed during nivolumab treatment and for a period of time following the final dose (patients should discuss breastfeeding considerations with their doctor).1,3

What are the possible side effects of nivolumab?

The most common side effects experienced by patients treated with nivolumab as a single medication include:1,3

More serious side effects

Nivolumab can cause some very serious side effects because when nivolumab helps the immune system to target and attack cancer cells, it can also cause the immune system to attack healthy cells. Your healthcare provider will talk with you about the signs and symptoms of the serious side effects that treatment with nivolumab can cause. These can include:1,3

  • Lung problems
  • Intestinal problems
  • Liver problems
  • Hormone gland problems
  • Kidney problems
  • Skin problems
  • Inflammation of the brain
  • Severe infusion reactions

If you experience any of the symptoms of severe side effects, let your healthcare provider know immediately. Immediate treatment can potentially help keep the side effects from getting worse.

These are not all the possible side effects of nivolumab. Talk to your doctor about what to expect when taking nivolumab. You also should call your doctor if you have any changes that concern you when taking nivolumab.