Nivolumab injection

What is this medicine?

NIVOLUMAB (nye VOL ue mab) is a monoclonal antibody. It is used to treat melanoma, lung cancer, kidney cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer, colon cancer, esophageal cancer, and liver cancer.

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional 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 pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• blood in the urine

• bloody or watery diarrhea or black, tarry stools

• changes in emotions or moods

• changes in vision

• chest pain

• cough

• dizziness

• feeling faint or lightheaded, falls

• fever, chills

• headache with fever, neck stiffness, confusion, loss of memory, sensitivity to light, hallucination, loss of contact with reality, or seizures

• joint pain

• mouth sores

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• severe muscle pain or weakness

• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• swelling of the ankles, feet, hands

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• weight gain or loss

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

• bone pain

• constipation

• decreased appetite

• diarrhea

• muscle pain

• nausea, vomiting

• tiredness

What may interact with this medicine?

Interactions have not been studied.

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 if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

Where should I keep my medicine?

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

What should I tell my health care provider before I take this medicine?

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

• diabetes

• immune system problems

• kidney disease

• liver disease

• lung disease

• organ transplant

• stomach or intestine problems

• thyroid disease

• an unusual or allergic reaction to nivolumab, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

This drug may make you feel generally unwell. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

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

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