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The product code(s) for this leaflet is: PL 41013/0018 .
Azacitidine Seacross
Azacitidine Seacross 25 mg/ml powder for suspension for injection
azacitidine
1. What Azacitidine Seacross is and what it is used for
2. What you need to know before you use Azacitidine Seacross
3. How to use Azacitidine Seacross
4. Possible side effects
5 How to store Azacitidine Seacross
6. Contents of the pack and other information
Azacitidine Seacross is an anti-cancer agent which belongs to a group of medicines called ‘anti- metabolites’. Azacitidine Seacross contains the active substance ‘azacitidine’.
Azacitidine Seacross is used in adults who are not able to have a stem cell transplantation to treat:
These are diseases which affect the bone marrow and can cause problems with normal blood cell production.
Azacitidine Seacross 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 Seacross works or why this medicine has been prescribed for you.
Talk to your doctor, pharmacist or nurse before using Azacitidine Seacross:
Azacitidine Seacross can cause a serious immune reaction called ‘differentiation syndrome’ (see section 4).
Blood test
You will have blood tests before you begin treatment with Azacitidine Seacross 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 Seacross 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 Seacross may affect the way some other medicines work. Also, some other medicines may affect the way Azacitidine Seacross works.
Pregnancy
You should not use Azacitidine Seacross 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 taking Azacitidine Seacross and for 6 months after stopping treatment with Azacitidine Seacross.
Tell your doctor straight away if you become pregnant during treatment.
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 taking this medicine.
Breast-feeding
You should not breast-feed when using Azacitidine Seacross. It is not known if this medicine passes into human milk.
Fertility
Men should not father a child while receiving treatment with Azacitidine Seacross. Men should use an effective method of contraception while taking Azacitidine Seacross and for 3 months after stopping treatment with Azacitidine Seacross.
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 Seacross, 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.
Other side effects include:
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
For UK, Yellow Card Scheme at website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
For IE, HPRA Pharmacovigilance, website: www.hpra.ie.
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 Seacross. They are also responsible for preparing and disposing of any unused Azacitidine Seacross correctly.
For unopened vials of this medicine – there are no special storage conditions.
When using immediately
Once the suspension has been prepared it should be administered within 45 minutes.
When using later on
If the Azacitidine Seacross 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 Seacross 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.
Azacitidine Seacross is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine. Each pack contains one vial of Azacitidine Seacross.
This leaflet was last revised in 02/2023.