Opdivo (nivolumab) is a treatment option for people with previously treated advanced squamous non-small cell lung cancer (NSCLC). People with chronic obstructive pulmonary disease (COPD) have a higher risk of getting lung cancer. One reason for this is that cigarette smoking is a major risk factor both for lung cancer and for COPD.

Bristol-Myers Squibb received approval for Opdivo from the US Food and Drug Administration (FDA) in March 2015.

How does Opdivo work?

Opdivo is a type of “immunotherapy” treatment; immunotherapy is different from chemotherapy because it works with the body’s immune system. The immune system’s function is to protect the body from viruses and bacteria, as well as from cancer cells and tumors within the body. The body’s usual immune response to cancer cells is to attack them with particular cells called “T cells.”

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However, some cancer cells are able to avoid the immune system’s attack by sending out special signals that inactivate those T cells and keep them from working against the tumor. Opdivo works by re-activating the T cells to help the immune system fight cancer.

Opdivo is given to patients as an intravenous (IV) infusion. Patients receive the infusion over a 1-hour period, usually every two weeks.

How effective is Opdivo?

To earn approval from the US FDA, clinical trials tested the effectiveness of Opdivo treatment by comparing it to treatment with platinum-based chemotherapy (docetaxel). The patients who were treated with Opdivo had a 41% greater chance of staying alive than patients treated with docetaxel, and 50% of Opdivo-treated patients were still alive after 9 months.

Who can take Opdivo?

Opdivo is approved for patients who have tried platinum-based chemotherapy, but during or after treatment their lung cancer has still spread or grown. It is not yet known if Opdivo is safe for people aged less than 18 years.

Before prescribing Opdivo, healthcare providers need to know if patients have any other medical conditions, especially if they:

• Have immune system problems, such as Crohn’s disease, ulcerative colitis, or lupus
• Have had an organ transplant
• Have lung or breathing problems
• Have liver problems
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed
• Are taking any other medicines, vitamins or supplements

What serious side effects can Opdivo cause?

Because of the way that Opdivo works to help the body’s immune system to fight cancer cells, it can sometimes cause the immune system to attack the body’s healthy organs and tissues as well. This can cause severe and even life-threatening problems, so it is very important to consult a healthcare provider right away if a patient develops any of the following symptoms of serious side effects:

Symptoms of lung problems (also called pneumonitis):

• New or worsening cough
• Chest pain
• Shortness of breath

Symptoms of intestinal problems (also called colitis):

• Diarrhea (loose stools) or more bowel movements than usual
• Blood in the stool or dark, tarry, sticky stools
• Severe stomach area (abdomen) pain or tenderness

Symptoms of liver problems (hepatitis):

• Yellowing of your skin or the whites of your eyes
• Severe nausea or vomiting
• Pain on the right side of your stomach area (abdomen)
• Drowsiness
• Dark urine (tea-colored)
• Bleeding or bruising more easily than normal
• Loss of appetite

Symptoms of kidney problems:

• Decrease in the amount of urine
• Blood in the urine
• Ankle swelling
• Loss of appetite

Symptoms of hormone gland problems:

• Unusual headaches or headaches that will not go away
• Extreme tiredness
• Weight gain or weight loss
• Changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness)
• Dizziness or fainting
• Hair loss
• Feeling cold
• Constipation
• Voice getting deeper

Symptoms of problems with other organs:

• Rash
• Changes in eyesight
• Severe or persistent muscle or joint pains
• Severe muscle weakness

What are the most common side effects of Opdivo?

The most common side effects reported by people with lung cancer who are taking Opdivo include:

• Feeling tired
• Shortness of breath
• Pain in muscles, bones, and joints
• Decreased appetite
• Cough
• Nausea
• Constipation

These are not all the possible side effects of Opdivo. Patients should talk to their doctor about what to expect with treatment with Opdivo.

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Written by: Anna Nicholson | Last reviewed: August 2020.