Nivolumab Solution for injection

What is this medicine?

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

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

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

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. Special care may be needed.

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?

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

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 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.

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

• black, tarry stools

• blood in the urine

• bloody or watery diarrhea

• changes in vision

• change in sex drive

• changes in emotions or moods

• chest pain

• confusion

• cough

• decreased appetite

• diarrhea

• facial flushing

• feeling faint or lightheaded

• fever, chills

• hair loss

• hallucination, loss of contact with reality

• headache

• irritable

• joint pain

• loss of memory

• muscle pain

• muscle weakness

• seizures

• shortness of breath

• 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

• stiff neck

• swelling of the ankles, feet, hands

• weight gain

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

• 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 medicine?

This drug 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.