nivolumab

What is the most important information I should know about nivolumab?

What is nivolumab?

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 may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving nivolumab?

Tell your doctor if you have ever had:

• 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.

How is nivolumab given?

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.

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.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving nivolumab?

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

What are the possible side effects of nivolumab?

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.

• 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.

Common 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.

What other drugs will affect nivolumab?

Other drugs may affect 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.

Where can I get more information?

Your pharmacist can provide more information about nivolumab.