Opdivo

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.

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.

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 Opdivo (Nivolumab).

Blood counts: Opdivo (Nivolumab) 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: Opdivo (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 Opdivo (Nivolumab).

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

Digestive tract problems: People receiving Opdivo (Nivolumab) have experienced severe diarrhea or inflammation of the bowel. If you have a history of ulcers or Diverticulitis, discuss with your doctor how Opdivo (Nivolumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Opdivo (Nivolumab), 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.

Heart problems: Opdivo (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.

Infusion reactions: Opdivo (Nivolumab) 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: Opdivo (Nivolumab) 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, Opdivo (Nivolumab) 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: Opdivo (Nivolumab) may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Opdivo (Nivolumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Opdivo (Nivolumab), 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 Opdivo (Nivolumab).

Lung problems: Opdivo (Nivolumab) and similar medications can cause lung problems. If you experience difficulty breathing or shortness of breath while you are taking Opdivo (Nivolumab), 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 Opdivo (Nivolumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Opdivo (Nivolumab), and whether any special monitoring is needed.

Skin reactions: Opdivo (Nivolumab) 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 Opdivo (Nivolumab), wear sunscreen and a hat and limit sun exposure.

Swelling in the brain: Although uncommon, Opdivo (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 Opdivo (Nivolumab) 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: Opdivo (Nivolumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Opdivo (Nivolumab), contact your doctor immediately.

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

Breast-feeding: It is not known if Opdivo (Nivolumab) passes into breast milk. If you are a breast-feeding mother and are taking Opdivo (Nivolumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Opdivo (Nivolumab) have not been established for children.