Active ingredient
- durvalumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 17901/0327.
IMFINZI 50 mg/mL concentrate for solution for infusion
Package leaflet: Information for the patient
IMFINZI® 50 mg/mL concentrate for solution for infusion
durvalumab
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
1. What IMFINZI is and what it is used for
2. What you need to know before you are given IMFINZI
3. How you are given IMFINZI
4. Possible side effects
5. How to store IMFINZI
6. Contents of the pack and other information
1. What IMFINZI is and what it is used for
IMFINZI is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults. It is used when your NSCLC:
IMFINZI is used to treat a type of lung cancer called extensive-stage small cell lung cancer (ES-SCLC) in adults. It is used when your SCLC:
IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body. IMFINZI works by helping your immune system fight your cancer.
If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, ask your doctor or pharmacist.
IMFINZI will be given in combination with chemotherapy for SCLC. It is important that you also read the package leaflets for the specific chemotherapy you may be receiving. If you have any questions about these medicines, ask your doctor.
2. What you need to know before you are given IMFINZI
You should not be given IMFINZI
Warnings and precautions
Talk to your doctor before you are given IMFINZI if:
If any of the above apply to you (or you are not sure), talk to your doctor before you are given IMFINZI.
When you are given IMFINZI, you can have some serious side effects.
If you have any of the following, call or see your doctor straight away. Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms. Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:
If you have any of the symptoms listed above, call or see your doctor straight away.
Children and adolescents
IMFINZI should not be used in children and adolescents below 18 years of age.
Other medicines and IMFINZI
Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription.
Pregnancy
Breast-feeding
Driving and using machines
IMFINZI is not likely to affect you being able to drive and use machines.
However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.
3. How you are given IMFINZI
IMFINZI will be given to you in a hospital or clinic under the supervision of an experienced doctor.
If you miss an appointment to get IMFINZI
If you have any further questions about your treatment, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When you get IMFINZI, you can have some serious side effects (see section 2).
Talk to your doctor straight away if you get any of the following side effects, that have been reported in clinical trials with patients receiving IMFINZI alone and includes the serious side effects listed in section 2:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
The following side effects have been reported in clinical trials in patients taking IMFINZI in combination with chemotherapy:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Talk to your doctor straight away if you get any of the side effects listed above.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store IMFINZI
IMFINZI will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage. The storage details are as follows:
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original package in order to protect from light.
Do not use if this medicine is cloudy, discoloured or contains visible particles.
Do not store any unused portion of the infusion solution for re-use. Any unused medicine or waste material should be disposed of in accordance with local requirements.
6. Contents of the pack and other information
What IMFINZI contains
The active substance is durvalumab.
Each mL of concentrate for solution for infusion contains 50 mg of durvalumab.
Each vial contains either 500 mg of durvalumab in 10 mL of concentrate or 120 mg of durvalumab in 2.4 mL of concentrate.
The other ingredients are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
What IMFINZI looks like and contents of the pack
IMFINZI concentrate for solution for infusion is a sterile, preservative-free, clear to opalescent, colourless to slightly yellow solution, free from visible particles.
It is available in packs containing either 1 glass vial of 2.4 mL of concentrate or 1 glass vial of 10 mL of concentrate.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in September 2021.
© AstraZeneca 2021
IMFINZI is a registered trademark of the AstraZeneca group of companies.
ONC 21 0073
Other sources of information
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000
Please be ready to give the following information:
Product name Reference number
Imfinzi 50mg/ml solution for infusion 17901/0327
2 Pancras Square, 8th Floor, London, N1C 4AG, UK
+44 (0)1582 838 000
+44 (0)1582 836 000
0800 783 0033
+44 (0)1582 838 003