Nivolumab, Injection

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KEY POINTS

• This medicine is given by IV to treat skin cancer, lung cancer, kidney cancer, and certain types of lymphoma.
• This medicine can cause serious side effects in your brain, eyes, lungs, kidneys, nerves, intestines, liver, pancreas, or skin which can lead to death. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); monoclonal antibody

Generic and brand names: nivolumab, injection; Opdivo

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat skin cancer (melanoma):

• That has spread or cannot be removed by surgery
• After you have taken other medicine and it did not work or is no longer working

This medicine may also be used to treat lung cancer, kidney cancer, and certain types of lymphoma.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A condition that affects your immune system, such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis
• An organ transplant
• Breathing problems or lung disease
• Diabetes
• Liver disease

Also tell your provider if you have recently had any kind of infection or if you are taking chemotherapy, radiation therapy, or steroid medicine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Use effective birth control during treatment with this medicine and for at least 5 months after you stop treatment. Do not breast-feed while you are taking this medicine.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start this medicine and each time you get a treatment.

These infusions are given by your healthcare provider. They are usually given every 2 weeks (depending on your response to the medicine). Keep all appointments for the infusions.

This medicine may cause a severe infusion reaction. Tell your provider right away if you have these symptoms during an infusion of this medicine:

• Chills or shaking
• Itching or rash
• Flushing
• Trouble breathing
• Dizziness or fainting
• Fever

What should I watch out for?

This medicine can cause your immune system to attack normal organs and tissues in many areas of your body. This can cause serious or life-threatening side effects in your brain, eyes, lungs, kidneys, nerves, glands, intestines, liver, pancreas, or skin which can lead to death. These side effects are most likely to start during treatment, but may start weeks or months after your last infusion. Talk with your healthcare provider about this.

You need regular lab tests to find out how this medicine is affecting you. Keep all your appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (Report these to your healthcare provider right away.): Fever; unusual tiredness or weakness; numbness or tingling in hands or feet; black, bloody, or tarry bowel movements; severe diarrhea or constipation; yellowing of your skin or eyes; dark urine; severe stomach pain, nausea, or vomiting; pain on the right side of your stomach; unexplained loss of appetite; severe drowsiness; unusual bruising or bleeding; sores in your mouth; blistering or peeling skin; unusual headaches or headache that won't go away; feeling cold all the time; changes in mood or behavior; confusion; memory problems; hallucinations; seizures; stiff neck; dizziness or fainting; unexplained weight gain or loss; deepening voice or hoarseness; vision problems; eye pain or redness; chest pain; fast or irregular heartbeat; trouble breathing; new or worsening cough; increased or decreased urination; blood in the urine; unexplained swelling; severe muscle or joint pain.

Other: Runny or stuffy nose, sore throat.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.