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PrOPDIVO®

(op-DEE-voh)

nivolumab 10 mg/mL

Download the Product Monograph

 

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

 

Pr OPDIVO® has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for Pr OPDIVO® please refer to Health Canada’s Notice of Compliance with conditions - drug products web site: http://www.hc-sc.gc.ca/dhpmps/prodpharma/notices-avis/conditions/index-eng.php.
Pr OPDIVO®, indicated for the treatment of patients with
  • Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. An improvement in survival or disease-related symptoms has not been established.
  • Unresectable or metastatic BRAF V600 mutation-positive melanoma in previously untreated adults. An improvement in survival has not yet been established.
  • Unresectable or metastatic melanoma in previously untreated adults when used in combination with ipilimumab.
    Relative to OPDIVO monotherapy, an increase in progression-free survival (PFS) for the combination of OPDIVO with ipilimumab is established only in patients with low tumour PD-L1 expression (based on the predefined expression level of < 5%).
    An improvement in survival has not yet been established.
Pr OPDIVO® has been issued marketing authorization without conditions for the treatment of:
  • Unresectable or metastatic BRAF V600 wild-type melanoma in previously untreated adults
  • Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving OPDIVO
  • Adult patients with advanced or metastatic renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy

 


PATIENT MEDICATION INFORMATION

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

 

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

 

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

PrOPDIVO®

(op-DEE-voh)

nivolumab 10 mg/mL

Read this carefully before you start taking OPDIVO and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about OPDIVO.

What is OPDIVO used for?

Skin Cancer:

OPDIVO® is a medicine to treat a type of skin cancer that has spread or cannot be removed by surgery (advanced melanoma) in adult patients.

OPDIVO may be given in combination with ipilimumab.  It is important that you also read the package leaflet for this medicine.  If you have any questions about ipilimumab, please ask your doctor. 

Lung Cancer:

OPDIVO is used in adult patients to treat a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown after treatment with platinum containing chemotherapy.

Kidney Cancer:

OPDIVO is used in adult patients to treat advanced kidney cancer (called renal cell carcinoma) that has spread or grown after treatment with medicines that block cancer blood vessel growth.

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 your healthcare 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, 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, 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). 
  • Had an organ transplant (such as a kidney transplant).
  • 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. 

When OPDIVO is given in combination with ipilimumab, you will be given an infusion over a period of 60 minutes, every 3 weeks for the first 4 doses (combination phase). Ipilimumab will be given on the same day. Thereafter it will be given as an infusion over a period of 60 minutes, every 2 weeks (single-agent phase).

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. 

When OPDIVO is given in combination with ipilimumab the recommended dose of OPDIVO is 1 mg of nivolumab per kilogram of your body weight for the first 4 doses (combination phase). Thereafter the recommended dose of OPDIVO is 3 mg of nivolumab per kilogram of your body weight (single-agent phase). 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. 

When OPDIVO is given in combination with ipilimumab, you will first be given OPDIVO followed by ipilimumab.

Please refer to the package leaflet of ipilimumab in order to understand the use of this medicine. If you have questions about this medicine, please 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 
  x  

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 
  x  

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 
  x  

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
  x  

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
  x  

Uncommon

(less than 1 in 100 but more than 1 in 1000)

Eye problems

Symptoms may include:

  • changes in eyesight
  • blurred vision
  x  

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
  x  

Rare

(less than 1 in 1,000 but more than 1 in 10,000)

Skin Problems

Symptoms may include:

  • severe rash
  • itching
  • skin blistering and peeling
  • ulcers in the mouth or other mucous membranes
  x  

Rare

(less than 1 in 1,000 but more than 1 in 10,000)

Problems with other organs, such as muscles, heart or nerves

Symptoms may include:

  • severe or persistent muscle or joint pains
  • severe muscle weakness
  • numbness or tingling in hands or feet
  • confusion or memory problems
  • abnormal heart beat
  • chest pain or chest discomfort
  • shortness of breath
  • swelling in extremities
  • fever
     
  x  

Severe infusion reactions may occur (uncommon: less than 1 in 100 but more than 1 in 1000). Symptoms may include chills or shaking, itching or rash, flushing, difficulty breathing, dizziness, fever, or feeling like passing out.

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).
  • An increased level of the enzyme that breaks down fats and of the enzyme that breaks down starch.
  • Increased or decreased amount of calcium or potassium.
  • Increased or decreased blood levels of magnesium or sodium.

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 to 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.

This leaflet was prepared by Bristol-Myers Squibb Canada

®Registered trademark  of Bristol-Myers Squibb Company used under licence by Bristol-Myers Squibb Canada

Last Revised October 2016