Consumer medicine information

Imfinzi 120 mg/2.4 mL Concentrated solution for infusion

Durvalumab

BRAND INFORMATION

Brand name

Imfinzi

Active ingredient

Durvalumab

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Imfinzi 120 mg/2.4 mL Concentrated solution for infusion.

1. Why am I using IMFINZI?


IMFINZI contains the active ingredient durvalumab. IMFINZI is used to treat several kind of cancers.
For more information, see Section 1. Why am I using IMFINZI? in the full CMI.

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.
For more information, see Section 2. What should I know before I use IMFINZI? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with IMFINZI and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

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.

More instructions can be found in Section 4. How do I use IMFINZI? in the full CMI.

5. What should I know while using IMFINZI?

Things you should do
  • 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.
Things you should not do
  • Do not miss a dose of IMFINZI
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how IMFINZI affects you.

For more information, see Section 5. What should I know while using IMFINZI? in the full CMI.

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.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Imfinzi

Active ingredient

Durvalumab

Schedule

S4

 

1 Name of Medicine

Durvalumab.

2 Qualitative and Quantitative Composition

Each vial of Imfinzi concentrated solution for infusion contains either 120 mg or 500 mg of durvalumab.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sterile, preservative free, clear to opalescent and free from visible particles, colourless to slightly yellow, concentrated solution for infusion.

4 Clinical Particulars

4.9 Overdose

There is no specific treatment in the event of durvalumab overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of durvalumab has not been evaluated. As a large protein molecule, durvalumab is not expected to interact directly with DNA or other chromosomal material.
Carcinogenicity. The carcinogenic potential of durvalumab has not been evaluated.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Durvalumab is a human immunoglobulin (IgG1κ) monoclonal antibody.
CAS number. 1428935-60-7.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

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