Consumer medicine information

IMFINZI®

 This medicine is subject to additional monitoring due to provisional approval of an extension of indication. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

IMFINZI®

Active ingredient(s): durvalumab

IMFINZI has provisional approval to treat a type of mesothelioma cancer called malignant pleural mesothelioma with epithelioid histology. The decision to approve this medicine has been made on the basis of promising results from preliminary studies. More evidence in a larger group of patients is required to be submitted when available to fully confirm the benefit and safety of the medicine for this use.


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?
2. What should I know before I use IMFINZI?
3. What if I am taking other medicines?
4. How do I use IMFINZI?
5. What should I know while using IMFINZI?
6. Are there any side effects?
7. Product details

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 is used to treat a type of lung cancer called non-small cell lung cancer. It will be prescribed to you if:

  • your cancer has spread within your lung and cannot be removed by surgery and;
  • you have tried radiation and chemotherapy that contains platinum, and your cancer has shrunk or has not worsened.

IMFINZI is also used to treat a type of lung cancer called extensive-stage small cell lung cancer. It will be prescribed to you if:

  • your cancer has spread within your lungs (or to other parts of the body) and
  • you have not received previous treatment.

IMFINZI will be given in combination with chemotherapy for this indication. It is important that you also read the consumer leaflets for the specific chemotherapy you will be receiving. If you have any questions about these medicines, ask your doctor.

IMFINZI has also provisional approval to treat a type of mesothelioma cancer called malignant pleural mesothelioma with epithelioid histology. It will be prescribed to you if:

  • your cancer has spread and cannot be removed by surgery and;
  • you have not received previous treatment.

IMFINZI will be given in combination with chemotherapy for this indication. It is important that you also read the consumer leaflets for the specific chemotherapy you will 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 any other medical conditions (including immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung or breathing problems or have liver problems)
  • 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 are a woman who 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.
  • Your doctor will decide how many treatments you need.

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

Serious side effects What to do
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 kidney:

  • 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.

Low number of platelets:

  • May include bleeding (e.g. 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.
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:

Most common side effects What do to
Reported in clinical trials with patients receiving IMFINZI alone:

  • cough
  • diarrhoea
  • stomach pain
  • skin rash or itchiness
  • fever
  • swelling of the legs (oedema peripheral)
  • upper respiratory tract infection
  • underactive thyroid gland that can cause tiredness or weight gain

Reported in a clinical trial with patients receiving IMFINZI with etoposide and carboplatin or cisplatin:

  • nausea
  • hair loss
  • decreased appetite
  • feeling tired or weak
  • constipation
  • vomiting
  • cough

Reported in clinical trials with patients receiving IMFINZI with pemetrexed and cisplatin or carboplatin:

  • fatigue
  • nausea
  • constipation
Speak to your doctor if you have any of these side effects and they worry you.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Some side effects can only be found when your doctor does blood tests from time to time to check your progress (for example, too much calcium in your blood, not enough sodium in your blood, not enough white blood cells, not enough red blood cells and not enough platelets).

Other 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

Active ingredient
(main ingredient)
durvalumab
Other ingredients
(inactive ingredients)
histidine
histidine hydrochloride monohydrate
trehalose dihydrate
polysorbate 80
water for injection.

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 in November 2022

IMFINZI is a trade mark of the AstraZeneca group of companies.

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© AstraZeneca 2022