How does this medication work? What will it do for me?

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.

Nivolumab is used to treat a number of different types of cancer including certain types of melanoma (skin cancer), non-small cell lung cancer, cancer of the tissue surrounding the lungs, kidney cancer, stomach cancer, esophageal cancer, and cancer of the head and neck.

Nivolumab has been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved this medication 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 nivolumab has been granted a NOC/c include certain stages of Hodgkin Lymphoma, colorectal cancer, or urothelial cancer. This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication 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 this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

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

What form(s) does this medication come in?

Each mL of sterile, preservative-free, non-pyrogenic, clear-to-opalescent, colourless-to-pale-yellow liquid for intravenous infusion contains 10 mg of 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.

How should I use this medication?

The recommended dose and treatment schedule for 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 this medication 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 this medication be given exactly as recommended by your doctor. If you miss an appointment to receive 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.

Who should NOT take this medication?

Do not take this medication if you are allergic to nivolumab or any ingredients of the medication.

What side effects are possible with this medication?

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 this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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.

  • altered sense of taste
  • cold- or flu-like symptoms (e.g., stuffy nose, sore throat, headache, fatigue)
  • constipation
  • decreased appetite
  • decreased interest in sexual activity
  • general feeling of being unwell
  • hair loss
  • headaches
  • heartburn or indigestion
  • hiccups
  • itchiness
  • muscle, joint, or bone pain
  • 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
  • decreased reflexes
  • decreased coordination
  • diarrhea
  • dizziness or fainting
  • increased blood pressure
  • 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
  • redness and swelling of the palms of the hands and soles of the feet
  • 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 kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
  • 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 myasthenia gravis (e.g., rapid fatigue of muscles, weakness, drooping eyelids, difficulty speaking or swallowing, or use of arms and legs)
  • symptoms of thyroid gland changes (e.g., tiredness, weight changes, heart rate changes, sweating)
  • vision changes, eye pain

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

  • chest pain
  • feeling of paralysis
  • 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 this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood counts: This medication can decrease the number of neutrophils (a type of white blood cell that helps fight infection), red blood cells (which carry oxygen), and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.

Diabetes: Nivolumab may cause a loss of blood glucose control and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Digestive tract problems: People receiving nivolumab have experienced severe diarrhea or inflammation of the bowel. If you have a history of ulcers or diverticulitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Gastrointestinal problems can cause diarrhea that may lead to dehydration (loss of too much water from the body). If you experience severe diarrhea for more than a day, or if you have diarrhea along with fever, decreased urination, dizziness, or a fast heartbeat, contact your doctor immediately.

If you experience signs of bleeding in the digestive tract, such as blood in the stool, or stools with a coffee-ground texture, contact your doctor immediately.

Drowsiness/dizziness: Nivolumab may affect the mental or physical abilities needed to drive or operate machinery by causing dizziness, tiredness, spinning sensations or changes in vision. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by this medication.

Heart problems: Nivolumab can cause inflammation of the heart muscle. If you experience symptoms of chest pain, irregular heartbeat, or a pounding heartbeat, contact your doctor as soon as possible.

Immune system reactions: Nivolumab can cause inflammation to many parts of the body, including the stomach, liver, skin, nerves, hormone glands (e.g. pituitary, adrenal, thyroid), and eyes. This may occur during treatment and up to several months after your last infusion. It is important that you contact your doctor as soon as possible about any concerning side effects.

Infusion reactions: This medication can cause a hypersensitivity or an infusion reaction. Symptoms of this type of reaction generally appear during the infusion of the medication and may include flushing, chest pain, shortness of breath, and a dramatic drop in blood pressure. These reactions can cause death if a health care provider is not informed immediately. If you experience any of these symptoms, or notice them happening to someone, let your nurse or doctor know immediately.

Kidney function: This medication can cause decreased kidney function or kidney failure. If you experience puffy hands, face, or feet; high blood pressure; unusual muscle cramping; or darkened urine, this medication may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Liver function: Nivolumab may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor as soon as possible.

Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Lung problems: Nivolumab and similar medications can cause lung problems. If you experience difficulty breathing or shortness of breath while you are taking this medication, contact your doctor immediately.

If you have or have had interstitial pneumonitis (swelling of the lungs causing cough and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Skin reactions: This medication commonly causes skin reactions. Some of these reactions can be severe. If you experience skin redness, itching, rash, peeling, cracks, dryness, or swelling and inflammation around the nails, contact your doctor. Since sunlight may worsen skin reactions caused by this medication, wear sunscreen and a hat and limit sun exposure.

Swelling in the brain: Although uncommon, nivolumab can cause inflammation and swelling in the brain (encephalitis). If you experience headache, fever, confusion, hallucinations, seizures, or a stiff neck, get immediate medical help.

Thyroid problems: Some people taking this medication develop changes in the function of their thyroid. Symptoms of these changes include feeling cold or hot all the time, a change in weight (gain or loss) without a change in your diet or amount of exercise you get, feeling emotional, tiredness, or having trouble sleeping. Contact your doctor if you experience these symptoms.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

A reliable method of birth control should always be used throughout the course of treatment with nivolumab and for 5 months after the last dose.

Breast-feeding: It is not known if nivolumab passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the website.

If you are taking other 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.

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.

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