Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using IMFINZI, speak
to your doctor or pharmacist.
1. Why am I using IMFINZI?
IMFINZI contains the active ingredient durvalumab. IMFINZI is used to treat several
kinds of cancers.
2. What should I know before I use IMFINZI?
Do not use if you have ever had an allergic reaction to IMFINZI or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with IMFINZI and affect how it works.
4. How do I use IMFINZI?
IMFINZI will be given to you as a liquid infusion into your vein and your doctor will
decide how many treatments you need.
5. What should I know while using IMFINZI?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using IMFINZI.
Keep all of your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do not miss a dose of IMFINZI
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how IMFINZI
affects you.
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6. Are there any side effects?
Like all medicines, IMFINZI can cause side effects, although not everybody gets them.
Your doctor will discuss these with you and will explain the risks and benefits of
your treatment.
When you take IMFINZI, you can have some serious side effects.
Active ingredient(s):
durvalumab
Consumer Medicine Information (CMI)
This leaflet provides important information about using IMFINZI. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using IMFINZI.
Where to find information in this leaflet:
1. Why am I using IMFINZI?
IMFINZI contains the active ingredient durvalumab. IMFINZI is a monoclonal antibody, a type of protein. It is a type of immunotherapy
and belongs to a group of medicines called immune checkpoint inhibitors. It works
with your immune system to destroy cancer cells.
IMFINZI can be used to treat a type of lung cancer called non-small cell lung cancer
(NSCLC). It may be prescribed to you:
in combination with chemotherapy that contains platinum prior to surgery (neoadjuvant
treatment) and alone after surgery (adjuvant treatment) if:
your cancer has spread within your lung and is able to be removed by surgery
alone if:
your cancer has spread within your lung and cannot be removed by surgery, and
you have tried radiotherapy and chemotherapy that contains platinum, and your cancer
has shrunk or has not worsened.
IMFINZI can be used to treat a type of lung cancer called small cell lung cancer (SCLC). It may be prescribed to you:
alone if:
you have limited stage SCLC (LS-SCLC) and
your cancer has not been removed by surgery and
your cancer has responded or stabilised after initial treatment with radiotherapy
and chemotherapy that contains platinum.
in combination with chemotherapy if:
you have extensive stage SCLC (ES-SCLC) where your cancer has spread within your lungs
(or to other parts of the body) and
you have not received previous treatment.
IMFINZI in combination with chemotherapy can be used to treat a type of cancer called
biliary tract cancer (BTC), such as cancer of the bile ducts (cholangiocarcinoma)
and gallbladder. It may be prescribed to you if:
your cancer has spread within these regions (or to other parts of the body).
IMFINZI in combination with tremelimumab can be used to treat a type of liver cancer,
called unresectable hepatocellular carcinoma (uHCC). It may be prescribed to you if your cancer:
cannot be removed by surgery (unresectable), and
has spread within your liver (or to other parts of the body)
IMFINZI can be used to treat a type of cancer of the lining of the uterus (endometrial
cancer) that has spread beyond the original tumour or come back (recurred). It may be prescribed to you in combination with chemotherapy, followed by IMFINZI
alone.
A test may be used to find out the mismatch repair (MMR) status of your endometrial
cancer to help your doctor decide which treatment option may be the best for your
cancer.
When IMFINZI is given in combination, it is important that you also read the Consumer
Medicine Information (CMI) for the specific anti-cancer medicines you may be receiving.
If you have any questions about these medicines, ask your doctor.
Your doctor may have prescribed IMFINZI for another reason.
2. What should I know before I use IMFINZI?
Warnings
Do not use IMFINZI if:
you are allergic to durvalumab, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use IMFINZI.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Check with your doctor if you:
have an autoimmune disease (a condition where the body attacks its own cells) like
Crohn's disease, ulcerative colitis or lupus. If you already have an autoimmune disease,
your risk of immune-mediated side effects may be higher with immune checkpoint inhibitor
medicines (such as IMFINZI) as they may cause inflammation in parts of your body.
You may also experience more frequent flares of your autoimmune disease, which in
the majority of cases are mild
have had an organ transplant
have lung or breathing problems
have liver problems
have any other medical conditions
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
You should not be given IMFINZI if you are pregnant.
It may affect your developing baby if you use it during pregnancy.
If you could become pregnant, you must use adequate birth control while you are being
treated with IMFINZI and for at least 3 months after your last dose.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You should not be given IMFINZI if you are breast-feeding.
It is not known if the active ingredient in IMFINZI passes into breast milk, but if
it does, there is a possibility that your baby may be affected.
Do not breast-feed if you are being given IMFINZI and for at least 3 months after
the last dose.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect IMFINZI.
4. How do I use IMFINZI?
How much and when to take IMFINZI
IMFINZI will be given to you as a liquid infusion into your vein (IV). An infusion
takes about 1 hour and will normally be given every 2, 3 or 4 weeks. 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 on the same day as chemotherapy, the IMFINZI infusion goes first,
followed by chemotherapy.
When IMFINZI is given on the same day as tremelimumab, the tremelimumab infusion goes
first, followed by IMFINZI.
Please refer to the CMI of the other anti-cancer medicines in order to understand
the use of these other medicines. If you have questions about these medicines, ask
your doctor.
If you miss an appointment to be given IMFINZI
Call your doctor right away to reschedule your appointment. It is very important that
you do not miss a dose of IMFINZI.
5. What should I know while using IMFINZI?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked.
Remind any doctor, dentist or pharmacist you visit that you are using IMFINZI.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how IMFINZI
affects you.
IMFINZI is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Store unopened vials under refrigeration at 2°C to 8°C in the original carton to protect
from light.
Do not freeze.
Do not shake.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use IMFINZI or it is out of date, take it to any pharmacy
for safe disposal.
Do not use IMFINZI after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
IMFINZI can cause your immune system to attack normal organs and tissues in many areas
of your body and can affect the way they work and this can cause the side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
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Serious side effects (signs and symptoms)
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What to do
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Problems with your lungs:
lung inflammation that may include new or worsening cough, shortness of breath, chest
pain
chronic obstructive pulmonary disorder (COPD) which causes the narrowing of airways
and makes it difficult to breathe.
lung infection (pneumonia or influenza) that may include coughing of phlegm, fever,
chills and difficulty breathing.
Problems with your liver:
inflammation of the liver that may include nausea or vomiting, feeling less hungry,
pain on the right side of stomach, yellowing of skin or whites of eyes, drowsiness,
dark urine or bleeding or bruising more easily than normal.
Problems with your intestines:
inflammation of the intestines may include diarrhoea or more bowel movements than
usual, black, tarry, sticky stools or stools with blood or mucous, severe stomach
pain or tenderness.
Problems with of some of your hormone glands:
inflammation of your hormone glands may include 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, increased
anxiety, irritability or forgetfulness, fast and deep breathing, confusion, or a sweet
smell to your breath, a sweet or metallic taste in your mouth or a different odour
to your urine or sweat.
Problems with your kidneys:
inflammation of your kidney that may include changes in the amount or colour of your
urine, swelling in your ankles or loss of appetite.
Problems with your urinary tract:
infection that may include the need to urinate urgently and frequently, burning pain
or sensation when urinating, bladder still feels full after urinating, pain above
your pubic bone, blood in the urine.
Problems with your skin or mouth:
inflammation of the skin or mouth may include rash, itching, skin blistering or ulcers
in the mouth or other mucous membranes.
thrush in the mouth.
Problems with your nose and throat:
nose or throat infection (sinusitis or tonsilitis)
Problems with your heart:
inflammation of your heart may include chest pain, shortness of breath or irregular
heartbeat.
Problems with your muscles:
inflammation of your muscles may include muscle weakness, tiredness and/or pain, and/or
rapid fatigue of the muscles, in one or more areas of your body.
Problems with your blood:
low number of blood platelets - may include bleeding (eg nose or gum bleeding) and/or
bruising.
Infusion-related reactions:
may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing,
dizziness, fever, feeling like passing out, back or neck pain or facial swelling.
Encephalitis or meningitis:
may include seizures, neck stiffness, headache, fever, chills, vomiting, eye sensitivity
to light, confusion and sleepiness.
Guillain-Barré syndrome:
may include pain, weakness, and paralysis in the extremities.
General body:
an inflammatory response that may include low or high body temperature, increased
heart rate, increased breathing rate and/or abnormal white blood cell count
Problems with your immune system:
immune system attacking your red blood cells - signs and symptoms may include unusual
weakness and fatigue with increased heart rate and breathing difficulties, yellowing
of the skin or whites of the eyes (jaundice), dark urine and/or an enlarged spleen
Inflammation of the spinal cord:
symptoms may include pain, numbness, tingling, or weakness in the arms or legs; bladder
or bowel problems including needing to urinate more frequently, urinary incontinence,
difficulty urinating and constipation
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Your doctor may give you other medicines in order to prevent more severe complications
and reduce your symptoms. Your doctor may withhold the next dose of IMFINZI or stop
your treatment with IMFINZI.
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Problems with your eyes:
inflammation of your eyes (uveitis) - signs and symptoms include eye redness, eye
pain, light sensitivity, and/or changes in vision
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Contact a medical eye specialist (ophthalmologist) straight away, or go straight to
the Emergency Department at your nearest hospital if you notice these side effects
as you may need urgent medical attention.
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Immune checkpoint inhibitor class effects
There have been cases of the following serious side effects reported during treatment
with other medicines in this class which may also occur during treatment with IMFINZI:
decreased ability of the pancreas to make digestive enzymes, which may result in symptoms
such as diarrhoea with loose and oily stools, weight loss, metabolic bone disease,
and vitamin or mineral deficiencies (known as exocrine pancreatic insufficiency)
decreased production of blood cells, which may result in symptoms such as weakness,
shortness of breath, dizziness, fast or irregular heartbeat, frequent infections,
unexplained or easy bruising, or bleeding from gums or other tissues (known as aplastic
anaemia)
a condition where the immune system makes too many infection-fighting cells which
may result in symptoms such as an enlarged liver and/or spleen, skin rash, lymph node
enlargement, breathing problems, easy bruising, kidney abnormalities and heart problems
(known as haemophagocytic lymphohistiocytosis)
coeliac disease which may result in symptoms such as stomach pain, diarrhoea and bloating
after consuming gluten-containing foods)
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Most common side effects reported in clinical trials:
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Most common side effects
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What do to
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Reported in clinical trials with patients receiving IMFINZI alone:
cough
diarrhoea
stomach pain
skin rash or itchiness
fever
swelling of the legs
upper respiratory tract infection
underactive thyroid gland that can cause tiredness or weight gain (hypothyroidism)
overactive thyroid gland which may cause many different symptoms including weight
loss, hand tremors, rapid or irregular heartbeat
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Speak to your doctor if you have any of these side effects and they worry you.
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Reported in a clinical trial with patients receiving IMFINZI in combination with chemotherapy
followed by IMFINZI alone:
nausea
constipation
feeling tired or weak (fatigue)
skin rash and itchiness
decrease in appetite
hair loss
diarrhoea
inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs
cough
vomiting
underactive thyroid gland that can cause tiredness or weight gain (hypothyroidism)
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Speak to your doctor if you have any of these side effects and they worry you.
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Reported in a clinical trial with patients receiving IMFINZI with etoposide and carboplatin
or cisplatin:
nausea
hair loss
decreased appetite
feeling tired or weak (fatigue)
constipation
vomiting
cough
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Speak to your doctor if you have any of these side effects and they worry you.
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Reported in clinical trials with patients receiving IMFINZI with gemcitabine and cisplatin:
low number of red blood cells (anaemia)
low number of white blood cells (neutropenia and leukopenia)
low number of blood platelets (thrombocytopenia)
diarrhoea
stomach pain
constipation
nausea
vomiting
feeling tired or weak (fatigue)
fever
abnormal liver function tests
decrease in appetite
skin rash and itchiness
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Speak to your doctor if you have any of these side effects and they worry you.
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Reported in clinical trials with patients receiving IMFINZI in combination with tremelimumab:
underactive thyroid gland that can cause tiredness or weight gain
stomach pain
diarrhoea
abnormal pancreas function test
swelling of the legs
fever
abnormal liver function tests
cough
skin rash or itchiness
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Speak to your doctor if you have any of these side effects and they worry you.
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Reported in a clinical trial with patients receiving IMFINZI in combination with carboplatin
and paclitaxel, followed by IMFINZI alone:
low number of red blood cells (anaemia)
nausea
feeling tired or weak (fatigue)
low number of white blood cells (neutropenia and leukopenia)
constipation
low number of platelets (thrombocytopenia)
diarrhoea
vomiting
stomach pain
decreased appetite
swelling of legs
underactive thyroid gland that can cause tiredness or weight gain (hypothyroidism)
abnormal liver function tests
muscle pain
inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs
cough / productive cough
hair loss
Skin rash or itchiness
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Speak to your doctor if you have any of these side effects and they worry you.
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Some side effects can only be found when your doctor does blood tests from time to
time to check your progress (eg abnormal thyroid gland function test (underactive
or overactive), too much calcium in your blood, not enough sodium in your blood, not
enough white blood cells, not enough red blood cells, not enough blood platelets,
abnormal liver function tests (eg aspartate aminotransferase (AST) increased; alanine
aminotransferase (ALT) increased) or pancreas function tests).
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell. Other less common side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems.
By reporting side effects, you can help provide more information on the safety of
IMFINZI.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
IMFINZI is only available with a doctor's prescription.
What IMFINZI contains
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Active ingredient
(main ingredient)
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durvalumab
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Other ingredients
(inactive ingredients)
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histidine
histidine hydrochloride monohydrate
trehalose dihydrate
polysorbate 80
water for injections
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Do not take IMFINZI if you are allergic to any of these ingredients.
What IMFINZI looks like
IMFINZI concentrated solution for infusion is a clear to opalescent, colourless to
slightly yellow liquid in a glass vial.
Australian Registration Number(s):
IMFINZI, 500 mg (500 mg/10mL) in 10 mL vial for intravenous infusion - AUST R 283216
IMFINZI, 120 mg (120 mg/2.4mL) in 10 mL vial for intravenous infusion - AUST R 283215
Who distributes IMFINZI
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: 1800 805 342
This leaflet was prepared 12 August 2025
IMFINZI is a trade mark of the AstraZeneca group of companies.
© AstraZeneca 2025
VV-RIM-01430609 v23