Opdivo (Nivolumab) belongs to the group of cancer-fighting medications known as antineoplastics. It is a monoclonal antibody that recognizes and attaches to certain types of cancer cells. This may prevent cancer cells from growing and dividing.

Opdivo (Nivolumab) is used to treat a number of different types of cancer including certain types of Melanoma (Skin Cancer), non-small cell Lung Cancer, kidney cancer, and cancer of the head and neck.

Opdivo (Nivolumab) has been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved Opdivo (Nivolumab) to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

The conditions for which Opdivo (Nivolumab) has been granted a NOC/c include certain stages of Hodgkin Lymphoma, colorectal cancer, or liver cancer. Opdivo (Nivolumab) may be available under multiple brand names and/or in several different forms. Any specific brand name of Opdivo (Nivolumab) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Opdivo (Nivolumab) may not be used for all of the conditions discussed here.

Your doctor may have suggested Opdivo (Nivolumab) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Opdivo (Nivolumab), speak to your doctor. Do not stop taking Opdivo (Nivolumab) without consulting your doctor.

Do not give Opdivo (Nivolumab) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Opdivo (Nivolumab) if their doctor has not prescribed it.

The recommended dose and treatment schedule for Opdivo (Nivolumab) is based on body weight and also depends on the type of cancer being treated. It is given by intravenous (into a vein) infusion, usually into a specially prepared site on the skin.

Very careful handling of Opdivo (Nivolumab) is required, and it is always given in a hospital or similar setting with access to sterile equipment for preparation of the medication and facilities to treat medical emergencies, such as infusion reactions.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important Opdivo (Nivolumab) be given exactly as recommended by your doctor. If you miss an appointment to receive Opdivo (Nivolumab), contact your doctor as soon as possible to reschedule your appointment.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Opdivo (Nivolumab). If you are concerned about side effects, discuss the risks and benefits of Opdivo (Nivolumab) with your doctor.

The following side effects have been reported by at least 1% of people taking Opdivo (Nivolumab). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• decreased appetite
• decreased interest in sexual activity
• Headaches
• heartburn or indigestion
• itchiness
• nausea
• rash
• unusual tiredness or sleepiness
• vomiting
• weakness
• weight changes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• confusion
• Diarrhea
• dizziness or fainting
• irritability
• kidney problems (e.g., decreased urine output, blood in urine, swollen ankles, loss of appetite)
• memory problems
• numbness or tingling in hands or feet
• persistent headache
• signs of Anemia (low red blood cells; e.g., pale skin, unusual tiredness or weakness)
• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of bowel inflammation (e.g., Fever that appears after starting the medication, watery and severe diarrhea [may also be bloody])
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, lack of coordination, thirst, confusion)
• signs of encephalitis (inflammation of the brain; e.g., headache, fever, tiredness or weakness, confusion, memory problems, sleepiness, seizures, stiff neck)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of muscle inflammation or damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
• swollen lymph nodes
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of lung problems (e.g., inflammation of the lung, trouble breathing, shortness of breath, cough, fever)
• symptoms of Thyroid gland changes (e.g., tiredness, weight changes, heart rate changes, sweating)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• irregular heartbeat or palpitations
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of an infusion reaction (e.g., chills or shaking, itching or rash, flushing, difficulty breathing, dizziness, fever, lightheadedness)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Opdivo (Nivolumab).

Each mL of sterile, preservative-free, non-pyrogenic, clear-to-opalescent, colourless-to-pale-yellow liquid for intravenous infusion contains 10 mg of Opdivo (Nivolumab). Nonmedicinal ingredients: sodium citrate dihydrate (5.88 mg/mL), sodium chloride (2.92 mg/mL), mannitol (30 mg/mL), pentetic acid (0.008 mg/mL), polysorbate 80 (0.2 mg/mL), and water for injection, USP; sodium hydroxide and/or hydrochloric acid may have been added to adjust pH.

Do not take Opdivo (Nivolumab) if you are allergic to Opdivo (Nivolumab) or any ingredients of the medication.

There may be an interaction between Opdivo (Nivolumab) and any of the following:

• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Ipilimumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Opdivo (Nivolumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.