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Opdivo (nivolumab)

What is Opdivo?

Opdivo® (nivolumab) is a treatment option for some patients who have advanced or metastatic bladder cancer.1 It is an immunotherapy drug that was approved for treating bladder cancer by the U.S. Food and Drug Administration (FDA) in 2017. Patients receive treatment with nivolumab through an intravenous (IV) infusion, which is typically a 30 minute infusion. Most bladder cancer patients receive treatment with nivolumab every two or four weeks, depending on the patient’s dosing schedule.

How does it 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.1,2 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.

Nivolumab is a type of immunotherapy drug called a PD-1 inhibitor, which is a relatively new type of treatment for advanced or metastatic 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.

Nivolumab was tested in clinical trials that included patients with advanced or metastatic bladder cancer, and some patients’ tumors became smaller after treatment.

Who can receive nivolumab?

Nivolumab is only used to treat 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.1,3 It is usually prescribed for patients with advanced or metastatic bladder cancer who have already tried treatment with platinum-based chemotherapy, but the treatment did not work or is not working anymore. If you have advanced or metastatic bladder cancer, your healthcare provider can talk with you about advantages and disadvantages of treatment with nivolumab.

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

  • 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

It is very important for women who are pregnant, planning to become pregnant, or breastfeeding to let their healthcare provider know before starting treatment with nivolumab because of the serious side effects that treatment can cause. Women who are able to become pregnant should use effective birth control during nivolumab treatment and for at least five months after the last dose of nivolumab.

What are the possible side effects?

The most common side effects experienced by patients with advanced or metastatic bladder cancer being treated with nivolumab include 1,3:

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:

  • 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. This is not an exhaustive list of all potential side effects of nivolumab. Talk to your healthcare provider or pharmacist for further information.

Written by Anna Nicholson | Last review date: July 2019.
  1. Opdivo. http://www.opdivoinformation.com/. Accessed September 2017.
  2. Sharma, Padmanee et al. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. The Lancet Oncology, Volume 17, Issue 11, 1590 – 1598. November 2016.
  3. OPDIVO prescribing information. Bristol-Myers Squibb, 2017.