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Opdivo (nivolumab)

Opdivo® (nivolumab) is a type of immunotherapy. It is used to treat melanoma in the following ways:1

  • Alone, or as part of specific combination therapy, for melanoma that cannot be removed with surgery (unresectable) or has spread to distant parts of the body (metastasized)
  • Adjuvant treatment after complete resection in melanoma patients with disease in the lymph nodes or metastatic disease.

Nivolumab can be used alone or with a medication called Yervoy® (ipilimumab) in melanoma patients. Neither of these drugs comes in generic form. Nivolumab is similar to Keytruda® (pembrolizumab), another drug approved to treat unresectable or metastatic melanoma. Pembrolizumab is similar and approved to treat certain forms of melanoma.

Nivolumab is approved to treat other cancers as well, including: non-small cell lung cancer, kidney cancer, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, bladder cancer, along with others.1

How does Nivolumab work?

Melanoma cells disguise themselves in order to hide from your immune system’s T-cells. Nivolumab works because it prevents cancer cells from disguising themselves. Nivolumab is described in many ways, including:

  • immune checkpoint inhibitor
  • anti-PD-1 therapy
  • PD-1 inhibitor

T-cells (T-lymphocytes) are a type of white blood cell.2 T-cells fight cancer and infection. They travel through the body, checking whether the cells they find are normal (healthy) or foreign (unhealthy). A receptor on the outside surface, called PD-1, does the checking. PD-1 stands for “programmed death receptor-1.”

Cancer cells try to hide from T-cells. They have proteins called PD-L1 or PD-L2 (programmed death ligand-1 or 2) on their outside surface. When PD-L1 or PD-L2 binds (connects) to PD-1, it basically acts like an “off switch” for the T-cell. This makes the T-cell ignore the cancer cell.

Nivolumab binds to the PD-1 receptor.1 This blocks the receptor from interacting with PD-L1 or PD-L2. The T-cell is able to identify and attack the cancer cell.

How is Nivolumab given?

Before receiving Nivolumab, read the Medication Guide that comes in the package. If you are also receiving Yervoy, read the Medication Guide for that medication too. Talk to your doctor about how often and how many treatments you will need.

OpdiNivolumabvo is taken through an intravenous (IV) line. Your doctor will arrange for you to be given Nivolumab. It takes about 30 minutes to administer the medication.1 Nivolumab can be given every 2 to 4 weeks. Talk to your prescriber about the different dosing options.

If you are also taking Yervoy, you will take both medications on the same day. This combination is given every 3 weeks. Usually, a total of 4 doses of the combination are given, followed by continued nivolumab treatment.1

What are the side effects of Nivolumab?

The most common side effects of Nivolumab include:1

  • Feeling tired
  • Muscle, bone, or joint pain
  • Diarrhea or constipation
  • Cough or shortness of breath
  • Back pain
  • Fever
  • Rash or itchy skin
  • Nausea
  • Decreased appetite
  • Upper respiratory tract infection
  • Weakness

Nivolumab can cause your immune system to attack normal (healthy) organs and tissue. Rare but serious possible side effects include:

  • Lung inflammation (pneumonitis)
  • Intestinal inflammation (colitis)
  • Liver inflammation (hepatitis)
  • Problems with hormone glands (thyroid, pituitary, adrenal, pancreas)
  • Kidney inflammation and kidney failure
  • Skin problems
  • Brain inflammation
  • Other problems (changes in eye sight, severe muscle pain, severe or lasting muscle or joint pain)

Nivolumab is infused (put) into your vein through an IV line. Severe, life-threatening infusion reactions can occur. Symptoms include chills, shaking, difficulty breathing, itching, rash, flushing, dizziness, fever, and feeling like you may pass out.1

Who should not take Nivolumab?

Nivolumab can harm an unborn baby.1 Women who could become pregnant should use effective birth control during treatment. Continue using birth control for at least 5 months after the last dose of Nivolumab. Do not breastfeed while being treated with Nivolumab.

Tell your doctor about any medical conditions you have, especially:

  • Immune system problems (such as Crohn’s disease, ulcerative colitis, lupus).
  • Previous organ transplant.
  • Lung or breathing problems.
  • Liver problems.

What precautions are needed when taking Nivolumab?

You will need regular blood tests to check for side effects of Nivolumab. Your doctor may prescribe corticosteroids or hormone replacement medicines to treat certain side effects.1

Women who can become pregnant should use birth control during and for at least 5 months after treatment.1 Women should not breastfeed during treatment.

Written by: Sarah O'Brien | Last reviewed: June 2019.
  1. Opdivo® [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; February 2017.
  2. PubMed Health. T-Lymphocytes (T-Cells). Accessed April 7, 2017 at: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0022044/
  3. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372:320-330.
  4. Weber JS, D'Angelo SP, Minor D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015;16:375-384.
  5. NCCN Clinical Practice Guidelines in Oncology. Melanoma. Version 1.2017. Published November 10, 2016. https://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf
  6. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373:23-34.