When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to nivolumab, or if you are pregnant.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during your treatment time and for at least 5 months after your last dose.
• Do not breastfeed while you are being treated with this medicine.
• Tell your doctor if you have kidney disease, liver disease, breathing problems, or digestion problems.
• This medicine may cause the following problems because of the way it affects your immune system:
  
  • Severe inflammation, including pneumonitis (lungs), colitis (intestines), hepatitis (liver), nephritis (kidneys), or encephalitis (around the brain)
  • Overactive or underactive thyroid, or similar problems with other glands or body systems (including the nervous system)
  • Infusion reaction
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody or cloudy urine, decrease in how much or how often you urinate, or swelling of your face, feet, or lower legs
• Confusion, seizures, stiff neck, headache, fever, sleepiness
• Cough, chest tightness or pain, or trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Diarrhea that may contain blood, severe stomach pain
• Fever, chills, trouble breathing, dizziness, or skin rash while receiving the infusion
• Severe joint or muscle pain
• Weakness, headache, tiredness, weight changes, feeling cold, or changes in mood or behavior

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088