What Opdivo is used for and how to use it
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Opdivo - Consumer Medicine Information

Manufacture: Bristol-Myers Squibb
Country: Canada
Condition: Hodgkin's Lymphoma, Melanoma, Melanoma, Metastatic, Non-Small Cell Lung Cancer, Renal Cell Carcinoma
Class: Miscellaneous antineoplastics
Form: Liquid solution, Intravenous (IV)
Ingredients: nivolumab, hydrochloric acid, mannitol (E421), pentetic acid, polysorbate 80, sodium chloride, sodium citrate, sodium hydroxide, and water for injection

(op-DEE-voh)

nivolumab 10 mg/mL

What is OPDIVO used for

Skin Cancer

OPDIVO (nivolumab) is used in adult patients to treat a type of skin cancer (melanoma) that does not have a change (mutation) in the “BRAF” gene and that cannot be removed by surgery or has spread to other parts of the body.

Lung Cancer

OPDIVO is used in adult patients to treat a type of advanced stage lung cancer (called non-small cell lung cancer).

  • OPDIVO may be used when your cancer has spread or grown after treatment with chemotherapy.

It is not known if OPDIVO is safe and effective in children less than 18 years of age.

How does OPDIVO work

OPDIVO contains the active substance nivolumab which helps your immune system to attack and destroy cancer cells.

What are the ingredients in OPDIVO

The medicinal ingredient in OPDIVO is nivolumab.

The non-medicinal ingredients are hydrochloric acid, mannitol (E421), pentetic acid, polysorbate 80, sodium chloride, sodium citrate, sodium hydroxide, and water for injection.

OPDIVO comes in the following dosage forms

OPDIVO comes in glass vials containing either 40 mg (in 4 ml) or 100 mg (in 10 ml) of nivolumab.

Do not use OPDIVO if

You are allergic to nivolumab or any of the other ingredients of this medicine. Talk to yourhealthcare professional if you are not sure.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OPDIVO. Talk about any health conditions or problems you may have, including:

  • Problems with your hormone producing glands (including the thyroid, pituitary and adrenal glands, and pancreas) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include fatigue (extreme tiredness), weight change or headache or excessive thirst or lots of urine.
  • Diarrhea (watery, loose or soft stools) or any symptoms of inflammation of the intestines (colitis), such as stomach pain and mucus or blood in stool.
  • Abnormal liver function tests. Signs and symptoms may include eye or skin yellowing (jaundice), pain on the right side of your stomach area, or tiredness.
  • Problems with your lungs such as breathing difficulties, or cough. These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease).
  • Abnormal kidney function tests or problems with your kidneys, such as decreased volume of urine or inflammation of the kidneys (tubulointerstitial nephritis).
  • You had an organ transplant (such as a kidney transplant).
  • You take other medicines that make your immune system weak. Examples of these may include steroids, such as prednisone.

Other warnings you should know about

Tell your healthcare professional immediately if you have any of these signs or symptoms or if they get worse. Do not try to treat your symptoms with other medicines on your own.

Your healthcare professional may:

  • give you other medicines in order to prevent complications and reduce your symptoms,
  • withhold the next dose of OPDIVO.
  • or stop your treatment with OPDIVO.

Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose. Before treatment, your healthcare professional will check your general health.

Check with your healthcare professional before you are given OPDIVO if

  • you have an autoimmune disease (a condition where the body attacks its own cells);
  • you have melanoma of the eye;

Pregnancy and Breast-feeding

  • you are pregnant or plan to become pregnant. You should not become pregnant while you are getting OPDIVO, OPDIVO can cause harm or death to your unborn baby.
  • You must use effective contraception while you are being treated with OPDIVO and for at least 5 months after the last dose of OPDIVO if you are a woman who could become pregnant.
  • you are breast-feeding. OPDIVO may pass into your breast milk. You and your doctor should decide if you will take OPDIVO or breast-feed. You should not do both.

Always update your healthcare professional on your medical conditions.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take OPDIVO

You will receive treatment with OPDIVO in a hospital or clinic, under the supervision of an experienced healthcare professional.

You will get OPDIVO through an infusion (a method of putting the medicine directly into the bloodstream through a vein). It takes about 60 minutes to get a full dose.

OPDIVO is usually given every 2 weeks. Your healthcare professional may change how often you receive OPDIVO or how long the infusion may take.

Usual dose

The amount of OPDIVO you will be given will be calculated based on your body weight. The recommended dose is 3 mg of nivolumab per kilogram of your body weight.

Depending on your dose, some or all of the content of the OPDIVO vial may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection before use. More than one vial may be necessary to obtain the required dose.

If you stop using OPDIVO

Stopping your treatment may stop the effect of the medicine. Do not stop treatment with OPDIVO unless you have discussed this with your healthcare professional.

If you have any further questions about your treatment or on the use of this medicine, ask your healthcare professional.

Missed Dose

It is very important for you to keep all your appointments to receive OPDIVO. If you miss an appointment, ask your healthcare professional when to schedule your next dose.

What are possible side effects from using OPDIVO

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your healthcare professional will discuss these with you and will explain the risks and benefits of your treatment.

The following side effects have been reported in clinical trials with nivolumab:

Serious side effects and what to do about them

Symptom / effect Talk to your healthcare professional Stop taking drug and get immediate medical help
Only if severe In all cases
Very Common (may affect more than 1 in 10) Stomach problems
Symptoms may include:
- diarrhea (loose stools) or more bowel movements than usual. Do not treat the diarrhea yourself.
- Inflammation of the intestines (colitis)
- blood in stools or dark, tarry, sticky stools
- stomach pain (abdominal pain) or tenderness
Common (less than 1 in 10 but more than 1 in 100) Problems with hormone glands (pituitary, adrenal glands, or thyroid)
Symptoms may include:
- headaches or unusual tiredness or sleepiness
- weight gain
- changes in behaviour such as less sex drive, being irritable or forgetful
- dizziness or fainting
Common (less than 1 in 10 but more than 1 in 100) Liver problems
Symptoms may include:
- inflammation of the liver (hepatitis)
- yellowing of your skin or the whites of your eyes,
- dark urine, tiredness, nausea or vomiting, pain on the right side of your stomach, or bruise easily
Common (less than 1 in 10 but more than 1 in 100) Kidney problems
Symptoms may include:
- inflammation of the kidney (nephritis)
- decrease in urine output
- blood in urine
- swelling in ankles
- loss of appetite
Common (less than 1 in 10 but more than 1 in 100) Lung problems
Symptoms may include:
- inflammation of the lung (pneumonitis)
- trouble breathing, shortness of breath
- cough with or without mucus
- fever
Uncommon (less than 1 in 100 but more than 1 in 1000) Eye problems
Symptoms may include:
- changes in eyesight
- blurred vision
Rare (less than 1 in 1,000 but more than 1 in 10,000) Blood sugar problems (Type I diabetes mellitus)
Symptoms may include:
- hunger or thirst
- need to urinate more often
- weight loss
Rare (less than 1 in 1,000 but more than 1 in 10,000) Problems with other organs, such as skin, muscles, or nerves
Symptoms may include:
- skin blisters/peeling
- sores in your mouth
- severe or persistent muscle or joint pains
- severe muscle weakness
- numbness or tingling in hands or feet
- confusion or memory problems

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Changes in test results

OPDIVO may cause changes in the results of tests carried out by your healthcare professional. These include:

  • Abnormal liver function tests (increased amounts of the liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in your blood, higher blood levels of bilirubin)
  • Abnormal kidney function tests (increased amounts of creatinine in your blood)
  • A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot).

Tell your healthcare professional immediately if you get any of the side effects listed above.

 Do not try to treat your symptoms with other medicines on your own.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Patient Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9

Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage

It is unlikely that you will be asked to store OPDIVO yourself. It will be stored in the hospital or clinic where it is given to you.

Keep out of reach and sight of children.

Do not use OPDIVO after the expiry date which is stated on the label and carton after EXP. Store in a refrigerator (2°C – 8°C). Do not freeze.

Store in the original package in order to protect from light.

If you want more information about OPDIVO

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website at:

    http://www.bmscanada.ca

    or by contacting the sponsor, Bristol-Myers Squibb Canada at: 1-866-463-6267.