Nivolumab

What is nivolumab used for?

• Nivolumab is used to treat cancer.

Before taking nivolumab, tell your doctor:

• If you are allergic to nivolumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Lenalidomide, pomalidomide, or thalidomide.
• If you are breast-feeding. Do not breast-feed while you take nivolumab and for 5 months after you stop taking it.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take nivolumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take nivolumab?

• High blood sugar has happened with nivolumab. This includes diabetes that is new or worse.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Severe health problems like some organ problems can happen with nivolumab. This includes lung, liver, thyroid, pituitary, adrenal, pancreas, kidney, and muscle problems. Nerve problems or a very bad rash may also happen. Sometimes, these problems have been deadly. These problems may happen anytime during treatment or after treatment has stopped. Talk with the doctor.
• 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.
• Some people have had side effects during the infusion. Sometimes, these could be severe or life-threatening. Tell your doctor if you have back or neck pain, chills, shaking, dizziness, passing out, fever, flushing, itching, rash, shortness of breath, swelling of the face, or wheezing.
• Diarrhea, throwing up, upset stomach, and feeling less hungry are common with nivolumab. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not get better, or get very bad.
• It is common to have diarrhea with nivolumab. However, a severe bowel problem (colitis) with diarrhea has happened with nivolumab. This may lead to tears or holes in the bowels and may be life-threatening. Call your doctor right away if you have bloody stools; dark, tarry, or sticky stools; diarrhea; or severe stomach pain.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It 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.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start nivolumab to show that you are NOT pregnant.
• Women must use birth control while taking nivolumab and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

How is nivolumab best taken?

Use nivolumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Tell all of your health care providers that you take nivolumab. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check your blood sugar as you have been told by your doctor.
• If you are having a stem cell transplant, talk with your doctor. Some problems with stem cell transplants using stem cells from someone else (allogeneic) have happened after treatment with nivolumab. These problems can be very bad and can lead to death.
• This medicine may be used with another drug called ipilimumab. Some side effects that can happen may happen more often if nivolumab is used with ipilimumab. If you are also using ipilimumab, talk with your doctor about the risks and side effects that may happen.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of nivolumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of nivolumab:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of thyroid, pituitary, or adrenal gland problems. Some signs may be change in mood or the way you act, change in weight, constipation, deeper voice, dizziness, fainting, feeling cold, feeling very tired, hair loss, headache that lasts or is very bad, or lowered interest in sex.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Any unexplained bruising or bleeding.
• Muscle pain or weakness.
• Very bad joint pain.
• Swelling in the arms or legs.
• Chest pain.
• Feeling very tired or weak.
• A heartbeat that does not feel normal.
• A burning, numbness, or tingling feeling that is not normal.
• Loss of skin color in blotches.

Bladder cancer treatment:

• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.

What are some other side effects of nivolumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Bone or joint pain.
• Constipation.
• Stomach pain.
• Feeling tired or weak.
• Signs of a common cold.
• Trouble sleeping.
• Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out nivolumab?

• If you need to store nivolumab at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time nivolumab is refilled. If you have any questions about nivolumab, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take nivolumab or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to nivolumab. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.