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, kidney 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 melanoma, Hodgkin Lymphoma, or liver 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.
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.
The recommended dose of nivolumab is based on body weight and is usually calculated as 3 mg per kilogram of body weight. It is given by intravenous (into a vein) infusion, usually into a specially prepared site on the skin. The medication is infused over 60 minutes every 2 weeks.
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 take this medication if you are allergic to nivolumab or any ingredients of the 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.
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:
Stop taking the medication and seek immediate medical attention if any of the following occur:
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.
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.
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, people taking it should 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 a breast-feeding mother and are 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.
There may be an interaction between nivolumab and any of the following:
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