Pronunciation: nye VOL ue mab

Brand: Opdivo

What is the most important information I should know about nivolumab?

Nivolumab can cause side effects that may cause symptoms in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed. You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving nivolumab.

What is nivolumab?

Nivolumab is a cancer medicine that works with your immune system to interfere with the growth and spread of cancer cells in the body.

Nivolumab is used to treat certain types of cancer, including melanoma (skin cancer), non-small cell lung cancer, kidney cancer, squamous cell cancer of the head and neck, and Hodgkin Lymphoma. Nivolumab can be given alone or in combination with other cancer medicines. Nivolumab is often used after other medicines have been tried without success.

Nivolumab is sometimes used if the cancer has spread to other parts of the body. For some types of cancer, nivolumab is given when the cancer cannot be treated with surgery. For Hodgkin lymphoma, nivolumab is used if the condition has relapsed or progressed after stem cell transplant and treatment with brentixumab vedotin (Adcetris).

In people with non-small cell lung cancer, nivolumab may increase the chance of a longer survival time.

Nivolumab was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis for some types of cancer. In clinical studies, nivolumab produced complete or partial responses, or longer survival time without progression of the cancer. However, further studies are needed.

Nivolumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving nivolumab?

You should not use nivolumab if you are allergic to it.

To make sure nivolumab is safe for you, tell your doctor if you have:

  • lung disease or breathing problems;
  • liver disease;
  • kidney disease;
  • a thyroid disorder;
  • an autoimmune disorder such as lupus, Crohn's disease, or ulcerative colitis; or
  • if you have received an organ transplant.

Do not use nivolumab if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 5 months after your last dose.

It is not known whether nivolumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is nivolumab given?

Before you start treatment, your doctor will perform tests to make sure nivolumab is the best treatment for your type of cancer.

Nivolumab is injected into a vein through an IV. A healthcare provider will give you this injection.

Nivolumab is usually given once every 2 to 3 weeks. Your doctor will determine how long to treat you with this medicine.

Nivolumab must be given slowly. The IV infusion can take at least 1 hour to complete.

You may be given medication to treat or prevent certain side effects of nivolumab.

Nivolumab can cause certain side effects by changing the way your immune system works. These side effects can cause symptoms in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed or stopped altogether.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving nivolumab. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your nivolumab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving nivolumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of nivolumab?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, short of breath, itchy, tingly, chilled, or feverish.

Call your doctor at once if you have:

  • severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;
  • new or worsening skin rash;
  • sores or ulcers in your mouth, nose, rectum, or genitals;
  • severe muscle weakness, ongoing pain in your muscles or joints;
  • lung problems --new or worsening cough, sudden chest pain or discomfort, wheezing, feeling short of breath;
  • symptoms of brain swelling --confusion, headache, memory problems, hallucinations, neck stiffness, drowsiness, seizure (convulsions);
  • kidney problems --little or no urinating; blood in your urine; swelling in your feet or ankles;
  • liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • signs of a hormonal disorder --frequent or unusual headaches, vision problems, feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, vomiting, loss of appetite, diarrhea, constipation;
  • feeling weak, tired, or short of breath;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • fever, body aches;
  • cough, runny or stuffy nose;
  • skin rash, itching; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect nivolumab?

Other drugs may interact with nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about nivolumab.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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