Nivolumab

Generic Name: nivolumab (nye-VOL-ue-mab)
Brand Name: Opdivo

Nivolumab is used for:

Treating a type of skin cancer in certain patients. It is also used to treat a type of lung cancer. It may also be used for other conditions as determined by your doctor.

Nivolumab is a monoclonal antibody. It works by stopping the production of certain cells, which helps to treat cancer.

Do NOT use nivolumab if:

• you are allergic to any ingredient in nivolumab

Contact your doctor or health care provider right away if any of these apply to you.

Before using nivolumab:

Some medical conditions may interact with nivolumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have immune system problems (eg, Crohn disease, lupus, ulcerative colitis), liver problems, or lung or breathing problems
• if you have had an organ transplant

Some MEDICINES MAY INTERACT with nivolumab. However, no specific interactions with nivolumab are known at this time.

Ask your health care provider if nivolumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use nivolumab:

Use nivolumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Nivolumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get nivolumab refilled.
• Nivolumab is given as an infusion at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
• If you miss a dose of nivolumab, call your doctor to find out what to do.

Ask your health care provider any questions you may have about how to use nivolumab.

Important safety information:

• Severe and sometimes fatal lung problems have happened with nivolumab. Call your doctor right away if you have any symptoms of lung or breathing problems (eg, chest pain, new or worsening cough, shortness of breath, trouble breathing).
• 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. Call your doctor right away if you have bloody stools; dark, tarry, or sticky stools; diarrhea; or severe stomach pain.
• If you may become pregnant, you must use an effective form of birth control while you take nivolumab and for at least 5 months after you stop taking it. If you have questions about effective birth control, talk with your doctor.
• Lab tests may be performed while you use nivolumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: Nivolumab may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while taking nivolumab.

Possible side effects of nivolumab:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bone pain; constipation; cough; itching; loss of appetite; muscle or joint pain; nausea; rash; stomach pain; tiredness; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; severe muscle weakness; severe or persistent muscle or joint pain; swelling of the hands, ankles, or feet; symptoms of electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; seizures; severe or persistent diarrhea, nausea, or vomiting; severe muscle pain or weakness); symptoms of kidney problems (eg, unable to pass urine, change in the amount of urine passed, blood in the urine, a big weight gain, swelling in your ankles); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right-sided stomach pain, severe nausea or vomiting, unusual bruising or bleeding, unusual tiredness, yellowing of the skin or eyes); symptoms of thyroid or pituitary gland problems (eg, constipation, decreased sex drive, deeper voice, dizziness, fainting, feeling cold, hair loss, mood or behavior changes, severe or persistent headache, severe tiredness, weight changes); unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Nivolumab will be handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.

General information:

• If you have any questions about nivolumab, please talk with your doctor, pharmacist, or other health care provider.
• Nivolumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take nivolumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 nivolumab. 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 your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using nivolumab.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.