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Generic Name: nivolumab (nye VOL ue mab)
Brand Name: Opdivo

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 8, 2020.

What is nivolumab?

Nivolumab is a prescription cancer medicine that is used alone or in combination with other medicines to treat certain types of cancer.

Nivolumab is used to treat adults with:

Nivolumab is also used to treat adults and children 12 years and older with a type of colorectal cancer that laboratory testing proves to have certain specific DNA mutations.

Nivolumab is often given when the cancer has spread to other parts of the body, or cannot be surgically removed, or has come back after prior treatment.

For some types of cancer, nivolumab is given only if your tumor has a specific genetic marker (an abnormal "EGFR" or "ALK" gene).

Important Information

Nivolumab can cause side effects 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.

Call your doctor at once if you have: chest pain, cough, shortness of breath, vision changes, severe muscle pain or weakness, diarrhea and severe stomach pain, blood in your stools, little or no urinating, swelling, bruising or bleeding, dark urine, yellowing of the skin or eyes, confusion, hallucinations, a seizure, skin blistering, sores in your mouth, nose, rectum, or genitals, or a hormonal disorder (frequent headaches, feeling light-headed, increased thirst or urination, a deeper voice, feeling cold, weight gain or loss).

A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. Nivolumab can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Eye problems have happened with nivolumab. Some types of eye problems may need to be treated right away to lower the chance of long-lasting eyesight loss. Call your doctor right away if you have any changes in eyesight, eye pain, or very bad eye irritation.

A certain brain problem has happened with nivolumab. Rarely, this has been deadly. Call your doctor right away if you are confused, sleepy, very tired or weak, or have a fever, hallucinations, memory problems, seizures, stiff neck, or very bad headache.

Before taking this medicine

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 ever had:

You may need to have a negative pregnancy test before starting this treatment.

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 nivolumab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using nivolumab, and for at least 5 months after your last dose.

How is nivolumab given?

Nivolumab is given as an infusion into a vein by a healthcare provider. This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Your doctor will perform tests to make sure nivolumab is the best treatment for your type of cancer.

Nivolumab is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.

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

Nivolumab can cause side effects in many parts of your body by changing how your immune system works. Some side effects may be treated with other medicine, and your cancer treatments may be delayed or stopped.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving nivolumab.

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.

Nivolumab side effects

Get emergency medical help if you have signs of an allergic reaction to nivolumab (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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, itching, or blistering;

  • sores or ulcers in your mouth, nose, rectum, or genitals;

  • fever, swollen glands, body aches;

  • changes in your vision;

  • severe muscle weakness, ongoing pain in your muscles or joints;

  • (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling near your transplanted organ;

  • lung problems - new or worsening cough, chest pain, 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, blood in your urine;

  • liver problems - severe nausea or vomiting, right-sided upper stomach pain, lack of energy, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); or

  • signs of a hormonal disorder - frequent or unusual headaches, dizziness, fainting, mood or behavior changes, increased thirst or urination, constipation, hair loss, hoarse or deepened voice, feeling cold, weight gain, or weight loss.

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

Common nivolumab side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;

  • feeling weak, tired, or short of breath;

  • hormonal problems;

  • cold symptoms such as runny or stuffy nose, cough, sore throat;

  • fever, body aches;

  • headache, dizziness;

  • itching, rash; or

  • weight loss.

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 affect nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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