nivolumab 40 mg/4 mL intravenous solution

Generic name:
Nivolumab - injection

Pronunciation
(nye-VOL-ue-mab)

Brand name(s)
Opdivo

Nivolumab is used to treat cancer. It works by changing the action of your own immune system, directing it to attack cancer cells. Nivolumab belongs to a class of drugs known as monoclonal antibodies.

Read the Medication Guide provided by your pharmacist before you start receiving nivolumab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. It is injected slowly into a vein over 30 minutes. It is given as directed by your doctor, usually once every 2 to 4 weeks.

Infusion reactions may happen during the infusion of this drug. Tell your doctor right away if you have symptoms of infusion reactions such as fever, chills, flushing, dizziness, or fainting.

The dosage is based on your medical condition, weight, and response to treatment. Your doctor may stop your treatment for some time if you get serious side effects. Your doctor may also prescribe another medication (a corticosteroid such as prednisone) to help treat side effects of this medication.

See also How to Use section.

Nausea, diarrhea or constipation, loss of appetite, headache, bone/muscle pain, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• signs of infection (such as fever, runny/stuffy nose, new/worsening cough)
• diarrhea with blood/mucus
• mouth/throat sores
• severe stomach/abdominal pain
• symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine)
• signs of kidney problems (such as change in the amount of urine, pink/bloody urine)
• easy bruising/bleeding
• swelling hands/ankles/feet
• unusual weakness
• joint stiffness/pain
• muscle weakness/tenderness/pain/spasms/cramps
• numbness/tingling of arms/legs
• loss of coordination
• eye redness/pain
• sensitivity to light
• vision changes

Nivolumab may cause hormone gland problems (such as thyroid, pituitary, adrenal, pancreas). Your body could make too much or too little hormone. Tell your doctor right away if you have any symptoms such as:

• cold or heat intolerance
• unexplained weight loss/gain
• increased thirst/urination
• mood or behavior changes (such as decreased sex drive, irritability, forgetfulness)
• slow/fast/pounding/irregular heartbeat

Get medical help right away if you have any very serious side effects, including:

• chest pain
• shortness of breath

Nivolumab can commonly cause itching or a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash or itching.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using nivolumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• organ transplant
• stem cell transplant with donor cells

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nivolumab. Nivolumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 5 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 5 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as liver/kidney/thyroid function, blood sugar) should be done before and during treatment with this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.