Nivolumab is a cancer medicine that is used alone or in combination with other medicines to treat adults with:

• advanced skin cancer (melanoma);

• advanced non-small cell lung cancer;

• pleural mesothelioma (cancer that affects the lining of the lungs and chest wall);

• kidney cancer;

• classical Hodgkin lymphoma;

• cancer of the stomach and esophagus;

• squamous cell cancer of the esophagus or head and neck;

• bladder cancer;

• liver cancer; or

• colorectal cancer.

Nivolumab is often given when the cancer has spread to other parts of the body (metastatic), or cannot be surgically removed, or has come back after prior treatment.

Nivolumab is sometimes given only if laboratory testing shows specific genetic markers or DNA mutations associated with your cancer.

Nivolumab can cause side effects in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed.

Call your doctor at once if you have: a cough, shortness of breath, vision changes, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, little or no urinating, bruising or bleeding, dark urine, yellowing of your skin or eyes, frequent headaches, dizziness, confusion, increased thirst or urination, skin problems, numbness or tingling, feeling cold, or weight gain or loss.

A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. Nivolumab can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Eye problems have happened with nivolumab. Some types of eye problems may need to be treated right away to lower the chance of long-lasting eyesight loss. Call your doctor right away if you have any changes in eyesight, eye pain, or very bad eye irritation.

A certain brain problem has happened with nivolumab. Rarely, this has been deadly. Call your doctor right away if you are confused, sleepy, very tired or weak, or have a fever, hallucinations, memory problems, seizures, stiff neck, or very bad headache.

Nivolumab is given as an infusion into a vein by a healthcare provider. This medicine must be given slowly, and the infusion can take 30 to 90 minutes to complete.

Nivolumab is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving this medicine.

Nivolumab can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects, and your cancer treatments may be delayed if you need treatment for a side effect.

To make sure nivolumab is safe for you, tell your doctor if you have:

• chemotherapy or radiation treatment;

• a nervous system disorder such as myasthenia gravis or Guillain-Barré syndrome;

• liver disease;

• an autoimmune disorder (lupus, Crohn's disease, ulcerative colitis); or

• an organ transplant, or a stem cell transplant from a donor.

Nivolumab may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving nivolumab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using nivolumab, and for at least 5 months after your last dose.

Call your doctor for instructions if you miss a chemotherapy appointment.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to nivolumab (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, short of breath, itchy, or tingly, or if you have a fever, chills, back pain or neck pain.

Call your doctor at once if you have:

• severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;

• eye pain, vision changes, sensitivity to light;

• severe muscle pain or weakness;

• confusion, memory problems, neck stiffness, drowsiness, balance problems;

• numbness or tingling in your arms or legs;

• kidney problems - little or no urination, swelling in your feet or ankles, blood in your urine;

• liver problems - severe nausea or vomiting, right-sided upper stomach pain, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);

• lung problems - new or worsening cough, chest pain, feeling short of breath;

• skin problems - rash, itching, redness, swelling, pain, sores, blisters, sores in your mouth or nose or on your genitals;

• signs of a hormonal disorder - frequent or unusual headaches, vision problems, fast heartbeats, dizziness, fainting, tiredness, mood or behavior changes, hunger, increased thirst or urination, constipation, hair loss, hoarse or deepened voice, sweating, feeling cold, weight gain or loss; or

• (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling near your transplanted organ.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common nivolumab side effects may include:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;

• mouth sores, altered sense of taste;

• itching, rash, redness or blisters on your hands or feet;

• hormonal problems;

• liver problems;

• numbness, tingling, or burning pain in your hands or feet;

• fever, body aches;

• feeling weak, tired, or short of breath;

• cold symptoms such as runny or stuffy nose, cough, sore throat;

• headache, dizziness, increased blood pressure; or

• weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.