Patient Medication Information: uses, side effects, how to take - Imfinzi
Serious warnings and precautions box
IMFINZI in combination with tremelimumab or alone can cause serious side effects that can lead to death. These serious side effects may include: inflammation of the intestines (enterocolitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (Stevens-Johnson syndrome); inflammation of hormone glands that may affect how these glands work; inflammation of the lung tissue (pneumonitis or interstitial lung disease); inflammation of the heart muscle (myocarditis); inflammation of the brain (encephalitis); neuromuscular disease that leads to skeletal muscle weakness (myasthenia gravis). These serious side effects occur more often when IMFINZI is used together with tremelimumab. Please see Possible side effects from using IMFINZI
What IMFINZI is used for:
Bladder Cancer
IMFINZI is a medicine used to treat a type of bladder cancer (called urothelial carcinoma) including cancer of the ureter, urethra or kidney pelvis. It is used when your bladder cancer:
- Has spread and cannot be removed by surgery and,
- You have received chemotherapy, and it did not work or is no longer working.
IMFINZI is used to treat adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) which is when your bladder cancer has spread into the muscle layer of the bladder but not to other parts of the body. You will receive IMFINZI with chemotherapy before your bladder is removed followed by IMFINZI alone after the surgery.
IMFINZI is used to treat adults with a type of bladder cancer called non-muscle-invasive bladder cancer (NMIBC) which is when your bladder cancer has not spread from the lining to the muscle layer of the bladder. IMFINZI may be used in combination with Bacillus Calmette-Guérin (BCG) when your NMIBC is considered at high-risk to either get worse or to return even if successfully treated and is deemed suitable for BCG treatment.
Non-Small Cell Lung Cancer
IMFINZI is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
IMFINZI may be used in combination with chemotherapy prior to surgery (neoadjuvant treatment) and alone after surgery (adjuvant treatment) when your NSCLC:
- Has spread within your lung and is able to be removed by surgery.
IMFINZI may be given in combination with chemotherapy for NSCLC. It is important that you also read the package insert for the specific chemotherapy you may be receiving. If you have any questions about these medicines, ask your doctor.
IMFINZI is used alone when your NSCLC:
- Has grown within your lung and cannot be removed by surgery and,
- Has responded or stabilized after treatment with chemotherapy and radiation therapy.
IMFINZI is used to treat adults in combination with tremelimumab and chemotherapy when your NSCLC:
- Has spread within your lungs (and/or to other parts of the body), cannot be removed by surgery and
- Has shown no changes (mutations) in genes called epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK).
If you are given IMFINZI in combination with tremelimumab and chemotherapy, it is important that you also read the PATIENT MEDICATION INFORMATION for all the medications you may be receiving. If you have any questions about these medicines, ask your doctor.
Small Cell Lung Cancer
IMFINZI is used to treat adults with a type of lung cancer called limited-stage small cell lung cancer (LS-SCLC). It is used when your LS-SCLC:
- Cannot be removed by surgery and,
- Has responded or stabilized after initial treatment with chemotherapy that contains platinum and radiation therapy.
IMFINZI is used to treat adults with a type of lung cancer called extensive-stage small cell lung cancer (ES-SCLC). It is used when your ES-SCLC:
- Has spread within your lungs (or to other parts of the body) and,
- Has not previously been treated.
IMFINZI will be given in combination with chemotherapy for ES-SCLC. It is important that you also read the package insert for the specific chemotherapy you may be receiving. If you have any questions about these medicines, ask your doctor.
Biliary Tract Cancer
IMFINZI is used to treat adults with a type of cancer called biliary tract cancer (BTC), including cancer of the bile ducts (cholangiocarcinoma) and gallbladder. It is used when your BTC:
- Has spread within these regions or to other parts of the body.
IMFINZI will be given in combination with chemotherapy for BTC. It is important that you also read the package insert for the specific chemotherapy you may be receiving. If you have any questions about these medicines, ask your doctor.
Liver Cancer
IMFINZI alone or in combination with tremelimumab is used to treat adults with a type of liver cancer, called hepatocellular carcinoma (HCC), when your liver cancer:
- Cannot be removed by surgery (unresectable) and requires medication,
- May have spread within your liver or to other parts of the body, and
- You have not received other medicines to treat your liver cancer.
If you are given IMFINZI in combination with tremelimumab, it is important that you also read the PATIENT MEDICATION INFORMATION for both medications.
Endometrial Cancer
IMFINZI is used to treat adults with a type of uterine cancer (endometrial cancer) that has spread beyond the original tumour or come back (recurred) in adults. It is used in combination with chemotherapy (carboplatin and paclitaxel), followed by IMFINZI alone when your tumour is MMR-deficient.
A test is used to find out the MMR status of your endometrial cancer.
It is important that you also read the package insert for the specific chemotherapy you may be receiving. If you have any questions about these medicines, ask your doctor.
Stomach Cancer
IMFINZI is used to treat adults with a type of stomach cancer called gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJC) (Stage II to IVA) that can be removed by surgery. IMFINZI is used in combination with chemotherapy before and after surgery, followed by IMFINZI alone.
For the following indication, IMFINZI has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional. IMFINZI is used to treat adults with a type of bladder cancer (called urothelial carcinoma) including cancer of the ureter, urethra or kidney pelvis. It is used when your bladder cancer:
For the following indications, IMFINZI has been approved without conditions. This means it has passed Health Canada's review and can be bought and sold in Canada. IMFINZI is used to treat adults with a type of bladder cancer (called muscle invasive bladder cancer (MIBC)). It is used when your bladder cancer:
You will receive IMFINZI with chemotherapy before your bladder is removed followed by IMFINZI alone after the surgery. IMFINZI is used to treat adults with a type of bladder cancer called non-muscle-invasive bladder cancer (NMIBC) which is when your bladder cancer has not spread from the lining to the muscle layer of the bladder. IMFINZI may be used in combination with Bacillus Calmette-Guérin (BCG) when your NMIBC is considered at high-risk to either get worse or to return even if successfully treated and is deemed suitable for BCG treatment. IMFINZI is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used in combination with chemotherapy prior to surgery (neoadjuvant treatment) and alone after surgery (adjuvant treatment) when your NSCLC:
IMFINZI is used alone when your NSCLC:
IMFINZI is used to treat adults in combination with tremelimumab and chemotherapy when your NSCLC:
IMFINZI is used to treat adults with a type of lung cancer called limited-stage small cell lung cancer (LS-SCLC). It is used when your LS-SCLC:
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IMFINZI is used to treat adults with a type of lung cancer called extensive-stage small cell lung cancer (ES-SCLC). It is used when your ES-SCLC:
IMFINZI is used to treat adults with a type of cancer called biliary tract cancer (BTC), including cancer of the bile ducts (cholangiocarcinoma) and gallbladder. It is used when your BTC:
IMFINZI alone or in combination with tremelimumab is used to treat adults with a type of liver cancer, called hepatocellular carcinoma (HCC), when your liver cancer:
IMFINZI is used to treat adults with a type of uterine cancer (endometrial cancer) that has spread beyond the original tumour or come back (recurred) in adults. It is used in combination with chemotherapy (carboplatin and paclitaxel), followed by IMFINZI alone when your tumour is MMR-deficient. IMFINZI is used to treat adults with a type of stomach cancer called gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJC) (Stage II to IVA) that can be removed by surgery. IMFINZI is used in combination with chemotherapy before and after surgery, followed by IMFINZI alone. |
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. |
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How IMFINZI works:
- IMFINZI works by helping your immune system fight your cancer.
IMFINZI can help slow or stop your cancer from growing. It can also help shrink the tumour.
- The average time to respond to IMFINZI for a bladder cancer patient is approximately 1.5 months. However, this may vary from patient to patient.
If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, ask your healthcare professional.
The ingredients in IMFINZI are:
Medicinal ingredient: durvalumab.
Non-medicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, and water for injection.
IMFINZI comes in the following dosage form(s):
A solution in 10 mL single-use glass vials containing either 2.4 mL or 10 mL of 50 mg/mL durvalumab. After further dilution and preparation, IMFINZI is administered as an intravenous infusion.
Do not use IMFINZI if:
- You are allergic to durvalumab or any other ingredients in IMFINZI.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IMFINZI. Talk about any health conditions or problems you may have, including if you:
- Have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- Have had an organ transplant
- Have lung or breathing problems
- Have liver problems
- Have problems with hormone producing glands such as your thyroid, pituitary, adrenal glands or pancreas
- Have diabetes
- Are taking medicine(s) that affect the immune system such as a steroid
When you receive IMFINZI, you can have some serious side effects.
IMFINZI can cause your immune system to attack normal organs and tissues in your body and can affect the way they work.
Other warnings you should know about:
Pregnancy
- If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor before taking this medicine. You should not use IMFINZI if you are pregnant.
- IMFINZI can harm your unborn baby.
- If you are a woman who could become pregnant, you should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI.
Breastfeeding
- If you are breastfeeding or plan to breastfeed, tell your doctor.
- Do not breastfeed during treatment and for at least 3 months after the last dose of IMFINZI. It is not known if IMFINZI passes into your breast milk.
Driving and using machines
If you experience side effects affecting your ability to concentrate and react, do not drive or use machines until you feel better.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with IMFINZI:
No drug-drug interactions are expected with IMFINZI.
How to take IMFINZI:
- IMFINZI will be given to you in a hospital or clinic under the supervision of an experienced healthcare professional. Your healthcare professional will give you IMFINZI through an intravenous infusion into your vein for about 60 minutes.
- Depending on your type of cancer, IMFINZI may be given in combination with other anti-cancer medicines.
- Your doctor will decide how many treatments you need.
- When IMFINZI is given in combination with chemotherapy, you will first be given IMFINZI followed by chemotherapy.
- When IMFINZI is given in combination with tremelimumab and chemotherapy for your lung cancer, you will first be given tremelimumab followed by IMFINZI and then by chemotherapy.
If you have any questions about your treatment, ask your doctor.
Usual dose:
Bladder Cancer Where Surgery is Not Possible
The recommended dose is 10 mg of IMFINZI per kg of your body weight every 2 weeks or 1500 mg every 4 weeks. IMFINZI is given on its own.
Muscle Invasive Bladder Cancer (MIBC)IMFINZI in combination with chemotherapy before surgery: The recommended dose of IMFINZI is 1500 mg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles.
IMFINZI alone after surgery: The recommended dose of IMFINZI is 1500 mg every 4 weeks for up to 8 cycles.
Non-Muscle Invasive Bladder Cancer (NMIBC)
The recommended dose of IMFINZI is 1500 mg every 4 weeks for 13 cycles in combination with BCG induction and maintenance.
When IMFINZI is given in combination with BCG on the same day for your bladder cancer, you will first be given IMFINZI followed by BCG.
Resectable Non-Small Cell Lung Cancer
The recommended dose is 1500 mg of IMFINZI in combination with chemotherapy every 3 weeks for up to 4 cycles prior to surgery. Thereafter, IMFINZI is given on its own and the recommended dose of IMFINZI is 1500 mg every 4 weeks for up to 12 cycles.
Non-Small Cell Lung Cancer (NSCLC)
The recommended dose is 10 mg of IMFINZI per kg of your body weight every 2 weeks or 1500 mg every 4 weeks. IMFINZI is given on its own.
Metastatic Non-Small Cell Lung Cancer (mNSCLC)
The recommended dose is 1500 mg of IMFINZI in combination with 75 mg of tremelimumab and chemotherapy every 3 weeks for 4 cycles. After chemotherapy, the recommended dose is 1500 mg of IMFINZI every 4 weeks and a fifth dose of tremelimumab alongside IMFINZI dose 6 at week 16. Based on your specific type of NSCLC, chemotherapy maintenance may be given every 4 weeks.
When using IMFINZI in combination with tremelimumab and chemotherapy, consult the Product Monographs for tremelimumab and the specific chemotherapy for further information on these drugs.
Limited-Stage Small Cell Lung Cancer (LS-SCLC)
The recommended dose is 1500 mg every 4 weeks. IMFINZI is given on its own.
Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
The recommended dose is 1500 mg of IMFINZI every 3 weeks for a total of 4 doses in combination with chemotherapy. Thereafter, IMFINZI is given on its own and the recommended dose of IMFINZI is 1500 mg every 4 weeks.
When using IMFINZI in combination with chemotherapy, consult the Product Monographs for the specific chemotherapy for further information on these drugs.
Biliary Tract Cancer (BTC)
The recommended dose is 1500 mg of IMFINZI in combination with chemotherapy every 3 weeks. Thereafter, IMFINZI is given on its own and the recommended dose is 1500 mg every 4 weeks.
When using IMFINZI in combination with chemotherapy, consult the Product Monographs for the specific chemotherapy for further information on these drugs.
Liver Cancer
IMFINZI in combination with tremelimumab:
The recommended dose of tremelimumab is 300 mg as a single dose, followed by IMFINZI 1500 mg at Day 1 of Cycle 1. Continue IMFINZI 1500 mg on its own every 4 weeks.
When using IMFINZI in combination with tremelimumab, consult the Product Monograph for tremelimumab for further information on this drug.
IMFINZI alone:
The recommended dose of IMFINZI is 1500 mg every 4 weeks. IMFINZI is given on its own.
Endometrial Cancer
The recommended dose is 1120 mg of IMFINZI in combination with chemotherapy every 3 weeks for 6 cycles. Thereafter, IMFINZI is given on its own and the recommended dose of IMFINZI is 1500 mg every 4 weeks.
When using IMFINZI in combination with chemotherapy, consult the Product Monographs for the specific chemotherapy for further information on these drugs.
Stomach Cancer (GC/GEJC)
The recommended dose is 1500 mg of IMFINZI in combination with chemotherapy every 4 weeks before surgery for 2 cycles and after surgery for 2 cycles. Thereafter, IMFINZI is given on its own and the recommended dose is 1500 mg every 4 weeks for up to 10 cycles. A maximum of 12 treatment cycles is allowed post-surgery.
When using IMFINZI in combination with chemotherapy, consult the Product Monographs for the specific chemotherapy for further information on these drugs.
For all indications:
If your body weight is 30 kg or less, you must receive weight-based dosing, until your weight increases to greater than 30 kg.
It is not known if IMFINZI is safe and effective in children less than 18 years of age.
Overdose:
| If you think you, or a person you are caring for, have been given too much IMFINZI, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
It is very important that you keep all your appointments to get IMFINZI. If you miss an appointment, call your doctor as soon as possible to discuss next steps.
Possible side effects from using IMFINZI:
These are not all the possible side effects you may have when taking IMFINZI. If you experience any side effects not listed here, tell your healthcare professional.
The following side effects have been reported in clinical trials with patients receiving IMFINZI alone or in combination with tremelimumab or with chemotherapy or in combination with tremelimumab and chemotherapy or in combination with BCG; ask your doctor for more information regarding side effects of your treatment:
Very common side effects (may affect more than 1 in 10 people):
- low number of red blood cells (anemia)
- low number of white blood cells (neutropenia, lymphopenia or leukopenia)
- low number of blood platelets (thrombocytopenia)
- peripheral nerves damage
- abnormal kidney function tests (blood creatinine increased)
- nausea
- hair loss
- decreased appetite
- feeling tired or weak
- dizziness
- constipation
- vomiting
- cough
- diarrhea
- stomach or abdominal pain
- skin rash or itchiness
- fever
- swelling of the legs
- painful urination
- upper respiratory tract infection
- abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased)
- underactive thyroid gland that can cause tiredness or weight gain
- abnormal pancreas test
- inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs (neuropathy peripheral)
- COVID-19
- insomnia
When you start taking IMFINZI either alone or in combination with tremelimumab or chemotherapy, or if you’re taking IMFINZI in combination with tremelimumab and chemotherapy, it’s important to know that there can be some serious side-effects. See table below. If you experience any of these symptoms, it’s important to call or see your healthcare professional right away. They may give you other medicines to prevent more severe complications and reduce your symptoms. Depending on your situation, your healthcare professional may withhold the next dose of IMFINZI or stop your treatment with IMFINZI.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||
|---|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| Only if severe | In all cases | |||
| Only if severe | In all cases | |||
| Only if severe | In all cases | |||
| Only if severe | In all cases | |||
| Only if severe | In all cases | |||
Very Common (combination with chemotherapy, combination with tremelimumab and chemotherapy) | Leukopenia or Neutropenia (low white blood cells, low neutrophils): fever or infection, fatigue, flu-like symptoms. | ✓ | ||
Very Common (combination with chemotherapy, combination with tremelimumab and chemotherapy) | Anemia (low red blood cells): being short of breath, feeling very tired, having pale skin, fast heartbeat, loss of energy, or weakness. | ✓ | ||
Very Common (monotherapy, combination with tremelimumab) Common (combination with chemotherapy, combination with tremelimumab and chemotherapy) | Skin or mouth problems: rash, itching, skin blistering; ulcers in mouth or other mucous membranes when in combination with chemotherapy. | ✓ | ||
Very Common (monotherapy, combination with tremelimumab) Common (combination with chemotherapy, combination with tremelimumab and chemotherapy) | Hormone gland problems (especially the thyroid, adrenals, pituitary and pancreas): headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, changes to your voice, urinating more often than usual, nausea or vomiting, stomach area (abdomen) pain, changes in mood or behaviour, such as decreased sex drive, irritability, or forgetfulness, fast and deep breathing, confusion, a sweet smell to your breath, a sweet or metallic taste in your mouth, a different odour to your urine or sweat, increased frequency of urination (peeing) or feeling unusually thirsty. | ✓ | ||
Very Common (combination with tremelimumab and chemotherapy, combination with chemotherapy) Common (monotherapy, combination with tremelimumab,) | Pneumonia (infection in the lungs): cough with or without mucus, fever, chills, shortness of breath, chest pain including difficult and painful breathing. | ✓ | ||
Common (combination with chemotherapy) | Blood clots (embolisms): blockage of blood vessels that may include leg swelling and pain, shortness of breath, chest pain, coughing up blood (lung clots), fast heart rate, general weakness, feeling cold and numb. | ✓ | ||
Common (combination with chemotherapy, combination with tremelimumab and chemotherapy) | Febrile neutropenia (low number of white blood cells with signs of fever): fever or infection, fatigue, flu-like symptoms. | ✓ | ||
Common (monotherapy, combination with chemotherapy, combination with tremelimumab, combination with tremelimumab and chemotherapy) | Lung inflammation (pneumonitis): new or worsening cough, shortness of breath, chest pain. | ✓ | ||
Common (combination with chemotherapy, combination with tremelimumab and chemotherapy) | Pancytopenia (low number of red blood cells, white blood cells, and platelets): Leukopenia or Neutropenia: fever or infection, fatigue, flu-like symptoms. Anemia: being short of breath, feeling very tired, having pale skin, fast heartbeat, loss of energy, or weakness. Thrombocytopenia: bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness. | ✓ | ||
Common (monotherapy, combination with chemotherapy, combination with tremelimumab, combination with tremelimumab and chemotherapy) | Severe infusion reactions: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, facial swelling. | ✓ | ||
Uncommon (monotherapy, combination with chemotherapy) Common (combination with tremelimumab, combination with tremelimumab and chemotherapy) | Intestinal problems (colitis) that can lead to tears or holes in your intestine: diarrhea or more bowel movements than usual, stools that are black, tarry, sticky, or have blood or mucus, severe stomach area (abdomen) pain or tenderness. | ✓ | ||
Common (monotherapy, combination with chemotherapy, combination with tremelimumab, combination with tremelimumab,chemotherapy and combination with BCG) | Liver problems (hepatitis): yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual. | ✓ | ||
Uncommon (monotherapy, combination with tremelimumab, combination with tremelimumab and chemotherapy, combination with chemotherapy) | Kidney problems, including inflammation (nephritis) and kidney failure: decrease in the amount of urine, blood in your urine, swelling in your ankles, loss of appetite. | ✓ | ||
Very Common (combination with chemotherapy) Uncommon (monotherapy) Common (combination with tremelimumab, combination with tremelimumab and chemotherapy) | Muscle problems: muscle weakness, tiredness and/or pain, rapid fatigue of the muscles in one or more areas of your body. | ✓ | ||
Uncommon (monotherapy, combination with tremelimumab, combination with tremelimumab and chemotherapy) (combination with chemotherapy – not reported) | Problems in other organs: changes in eyesight, blurry vision, double vision, cloudy vision or other vision problems including temporary loss of vision, severe or persistent muscle or joint pains, chest pain, shortness of breath. | ✓ | ||
Uncommon (monotherapy, combination with tremelimumab, combination with chemotherapy) | Inflammation of the heart: chest pain, shortness of breath or irregular heartbeat. | ✓ | ||
Uncommon (monotherapy, combination with chemotherapy) (combination with tremelimumab and chemotherapy – not reported) | Inflammation of the joints (Arthritis): joint pain, swelling, and/or stiffness | ✓ | ||
Rare (monotherapy, combination with tremelimumab) Very Common (combination with chemotherapy, combination with tremelimumab and chemotherapy) | Thrombocytopenia (low blood platelets): bruising or bleeding (e.g., nose or gums) more easily than normal. | ✓ | ||
Rare (monotherapy, combination with tremelimumab) Uncommon (combination with tremelimumab and chemotherapy, combination with chemotherapy) | Inflammation of the brain (encephalitis): seizures, headache, fever, chills, vomiting, confusion and sleepiness. | ✓ | ||
Rare (monotherapy, combination with chemotherapy) (combination with tremelimumab and chemotherapy – not reported) | Inflammation of the eye (Uveitis): eye redness, eye pain, light sensitivity, and/or changes in vision. | ✓ | ||
Frequency not Known (monotherapy, combination with chemotherapy) (combination with tremelimumab and chemotherapy – not reported) | Inflammation of the nerves (Guillain-Barré syndrome): pain, weakness and paralysis in the hands, feet or arms. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
IMFINZI should not be used after the expiry date which is stated on the label and carton.
IMFINZI should be stored in a refrigerator (2° to 8°C) in the original package in order to protect from light. Do not freeze or shake. Any unused medicine or waste material should be disposed of in accordance with local requirements.
Keep out of reach and sight of children.
If you want more information about IMFINZI:
- 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 Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.astrazeneca.ca, or by calling 1-800-668-6000.
- This Patient Medication Information is current at the time of printing. The most up-to-date version can be found at www.astrazeneca.ca.
Date of Authorization: 2026-10-19
IMFINZI® and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.
