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: PL 17780/0963.
Azacitidine 25 mg/mL powder for suspension for injection
Azacitidine 25 mg/ml powder for suspension for injection
1. What Azacitidine is and what it is used for
2. What you need to know before you take Azacitidine
3. How to use Azacitidine
4. Possible side effects
5. How to store Azacitidine
6. Contents of the pack and other information
The name of the product is Azacitidine powder for suspension for injection (called Azacitidine throughout this leaflet).
Azacitidine is an anti-cancer agent which belongs to a group of medicines called ‘anti-metabolites’ and contains the active substance ‘azacitidine’.
Azacitidine is used in adults who are not able to have a stem cell transplant to treat:
These are diseases which affect the bone marrow and can cause problems with normal blood cell production.
Azacitidine works by preventing cancer cells from growing. Azacitidine becomes incorporated into the genetic material of cells (ribonucleic acid (RNA) and deoxyribonucleic acid (DNA)). It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA. These actions are thought to correct problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Talk to your doctor or nurse if you have any questions about how Azacitidine works or why this medicine has been prescribed for you.
Talk to your doctor, pharmacist or nurse before using Azacitidine if you have:
Azacitidine can cause a serious immune reaction called ‘differentiation syndrome’ (see section 4)
You will have blood tests before you begin treatment with Azacitidine and at the start of each period of treatment (called a ‘cycle’). This is to check that you have enough blood cells and that your liver and kidneys are working properly.
Azacitidine is not recommended for use in children and adolescents below the age of 18.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is because Azacitidine may affect the way some other medicines work. Also, some other medicines may affect the way Azacitidine works.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
You should not use Azacitidine during pregnancy as it may be harmful to the baby. If you are a woman who can become pregnant you should use an effective method of contraception while using Azacitidine and for 6 months after stopping treatment with Azacitidine.
Tell your doctor straight away if you become pregnant during treatment.
You should not breast-feed when using Azacitidine. It is not known if this medicine passes into human milk.
Men should not father a child while receiving treatment with Azacitidine. Men should use an effective method of contraception while using Azacitidine for 3 months after stopping treatment with Azacitidine.
Talk to your doctor if you wish to conserve your sperm before starting this treatment.
Do not drive or use any tools or machines if you experience side effects, such as tiredness.
Before giving you Azacitidine, your doctor will give you another medicine to prevent nausea and vomiting at the start of each treatment cycle.
This medicine will be given to you as an injection under the skin (subcutaneously) by a doctor or nurse. It may be given under the skin on your thigh, tummy or upper arm.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme at: 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.
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 vial label and the carton after EXP. The expiry date refers to the last day of that month.
Your doctor, pharmacist or nurse are responsible for storing Azacitidine. They are also responsible for preparing and disposing of any unused Azacitidine correctly.
Unopened vials - This medicinal product does not require any special storage conditions.
When using immediately
Once the suspension has been prepared it should be administered within 60 minutes.
When using later on
If the Azacitidine suspension is prepared using water for injections that has not been refrigerated, the suspension must be placed in the refrigerator (2 °C – 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 8 hours.
If the Azacitidine suspension is prepared using water for injections that has been stored in the refrigerator (2 °C – 8 °C), the suspension must be placed in the refrigerator (2 °C – 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 22 hours.
The suspension should be allowed up to 30 minutes prior to administration to reach room temperature (20 °C – 25 °C). If large particles are present in the suspension it should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Azacitidine is a white powder for suspension for injection and is supplied in a Type-I clear glass vial sealed with dark grey chloro butyl flurotec coated single slotted rubber stopper or dark grey bromo butyl omniflex coated single slotted lyo rubber stopper and aluminium flip off seal containing 100 mg of azacitidine.
Each pack contains one vial of Azacitidine.
This leaflet was last revised in November 2023.