Nivolumab Injection

Nivolumab injection is used to treat a variety of cancers. Nivolumab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Nivolumab comes as a solution (liquid) to be injected intravenously (into a vein) over 30 minutes by a doctor or nurse in a hospital or medical facility. Your doctor will decide how often you are to receive nivolumab injection. The schedule depends on the condition you have and your body's response to the medication.

Nivolumab may cause serious or life-threatening reactions during an infusion. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion: chills or shaking, itching, rash, flushing, difficulty breathing, dizziness, fever, back or neck pain, and feeling faint.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving nivolumab injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) or have ever had an organ transplant or received radiation therapy to your chest. Also tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition that causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; or thyroid, kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to take a pregnancy test before you receive nivolumab. You should not become pregnant while you are receiving nivolumab injection. You should use effective birth control to prevent pregnancy during your treatment with nivolumab injection and for at least 5 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving nivolumab injection, call your doctor immediately. Nivolumab injection may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving nivolumab injection and for 5 months after your final dose.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive nivolumab injection, call your doctor as soon as possible.

Nivolumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint, jaw, or bone pain
• muscle pain or weakness
• dry, cracked, scaly skin
• redness, swelling, or pain on the palms of your hand or soles of your feet
• dry eyes or mouth
• change in sense of taste

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, tell your doctor immediately or get emergency medical treatment:

• shortness of breath, new or worsening cough, chest pain
• diarrhea; stomach area pain or tenderness; or stools that are black, tarry, sticky, or contain blood
• tiredness or weakness, feeling cold, deepening of voice or hoarseness, rapid or irregular heartbeat, increased sweating, changes in weight (gain or loss), changes in mood or behavior (decreased sex drive, irritability, or forgetfulness), headaches, including those that are unusual or will not go away), confusion, hair loss, constipation, increased urination, increased thirst or appetite, dizziness or fainting; hair loss
• confusion; pain, burning, tingling, or numbness in the hands or feet
• fever; itching, rash, hives, or blisters on your skin
• yellowing of skin or eyes, dark-colored urine, nausea, vomiting, bleeding or bruising more easily than normal, loss of appetite, decreased energy, or pain on right side of stomach area
• swelling of face, arms, legs, feet or ankles; decreased urination; blood in urine; loss of appetite
• changes in vision, including sensitivity to light
• painful sores in mouth, nose, throat, or genital area

Nivolumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to nivolumab injection. For some conditions, your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with nivolumab.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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