Nivolumab injection

What is this medication?

NIVOLUMAB (nye VOL ue mab) is a monoclonal antibody. It treats certain types of cancer. Some of the cancers treated are colon cancer, head and neck cancer, Hodgkin lymphoma, lung cancer, and melanoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Opdivo

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Autoimmune diseases such as Crohn's disease, ulcerative colitis, or lupus
• Have had or planning to have an allogeneic stem cell transplant (uses someone else's stem cells)
• History of chest radiation
• Organ transplant
• Nervous system problems such as myasthenia gravis or Guillain-Barre syndrome
• An unusual or allergic reaction to nivolumab, other medicines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team regarding the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work done while you are taking this medication.

Do not become pregnant while taking this medication or for 5 months after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. There is a potential for serious harm to an unborn child. Talk to your care team for more information. Do not breast-feed an infant while taking this medication or for 5 months after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bloody or black, tar-like stools
• Change in vision
• Chest pain
• Diarrhea
• Dry cough, shortness of breath or trouble breathing
• Eye pain
• Fast or irregular heartbeat
• Fever, chills
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell count—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Mood and behavior changes-confusion, change in sex drive or performance, irritability
• Muscle pain or cramps
• Pain, tingling, or numbness in the hands or feet, muscle weakness, trouble walking, loss of balance or coordination
• Red or dark brown urine
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stomach pain
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bone pain
• Constipation
• Loss of appetite
• Nausea
• Tiredness
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.