This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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 17469/0012.
CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection
CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection
CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection
CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection
eptacog beta (activated)
▼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.
1. What CEVENFACTA is and what it is used for
2. What you need to know before you use CEVENFACTA
3. How to use CEVENFACTA
4. Possible side effects
5. How to store CEVENFACTA
6. Contents of the pack and other information
7. CEVENFACTA Instructions For Use
CEVENFACTA contains the active substance eptacog beta (activated), a recombinant human coagulation Factor VIIa (rhFVIIa).
CEVENFACTA is used in adults and adolescents (12 years of age or older) who were born with haemophilia A or B and who have developed inhibitors (antibodies). It is used for:
This medicine works by making the blood clot at the site of bleeding, when the body’s own clotting factors are not working.
Before treatment with CEVENFACTA, tell your doctor:
Patients with known allergy to casein may be at a higher risk of hypersensitivity reactions. Should signs or symptoms of hypersensitivity occur, treatment should be discontinued and you should seek immediate medical attention. Symptoms may include hives (itchy swellings under the skin), itching, rash, difficulty breathing, swelling around the mouth and throat, tightness of the chest, wheezing, dizziness or fainting, and low blood pressure.
Although the following conditions have not been observed, they may occur with CEVENFACTA:
If any of these conditions apply to you, talk to your doctor before using CEVENFACTA.
It is important to keep a record of the batch number of your CEVENFACTA. So, every time you get a new package of CEVENFACTA, note down the date and the batch number (which is on the packaging after Lot) and keep this information in a safe place.
The listed warnings and precautions apply both to adults and adolescents (12 years of age and older).
Tell your doctor if you are taking, have recently taken or might take any other medicines.
You should talk to your doctor before using CEVENFACTA if
You should talk to your doctor before using CEVENFACTA with these medicines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Dizziness might occur following administration of CEVENFACTA. You must avoid driving or using machines while experiencing this symptom.
This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium free’.
Treatment with this medicine should be initiated and supervised by a physician experienced in the treatment of haemophilia and/or bleeding disorders.
CEVENFACTA comes as a powder that must be made up (reconstituted) with its solvent and injected into a vein (intravenous injection). See instructions for use guide at the end of this leaflet (section 7).
Injecting medicines requires special training. Do not attempt to self-inject unless you have been taught how to by your healthcare provider or haemophilia treatment centre.
Many people with inhibitors learn to self-inject or inject with the help of a family member: once trained, you will need additional injection equipment along with your CEVENFACTA kit so that you can successfully treat your bleeding episodes at home. Be sure to collect all necessary injection equipment before preparing the medicine for injection. This additional injection equipment will be provided by your healthcare professional (e.g., your pharmacist or haemophilia treatment centre).
CEVENFACTA may be injected at a haemophilia treatment centre, at your healthcare provider’s office, or at home. Treating at the first sign of a bleed is important for bleed management.
Start treatment of a bleed as early as possible, ideally within 2 hours.
Usually, severe bleeds are treated at the hospital and a dose of CEVENFACTA can be given on the way there.
Do not treat yourself for longer than 24 hours without consulting your doctor.
For instructions on reconstitution of the medicinal product before administration, follow the Instructions For Use guide at the end of this leaflet (section 7).
Inject the solution into your vein over 2 minutes or less.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Your healthcare provider will tell you how much CEVENFACTA to use, and when to use this medicine based on your weight, condition and type of bleed.
Treatment of bleeding episodes
Treatment with this medicine should be started as soon as a bleeding event occurs.
Mild and moderate bleeding
For mild to moderate bleeding episodes, treatment at home should not last longer than 24 hours. Continuing home treatment after 24 hours can only be considered after consultation with the haemophilia treatment centre.
You should seek immediate medical care if signs or symptoms of severe bleeding occur at home.
An initial dose can be administered on your way to the haemophilia treatment centre or your healthcare provider’s office to avoid any treatment delay.
Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure.
For instructions on reconstitution of the medicinal product before administration and instructions on administration, follow the Instructions For Use guide at the end of this leaflet (section 7).
If you use too much CEVENFACTA, get medical advice at once.
If you forget to use CEVENFACTA, talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects
(may affect up to 1 in 10 people)
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.
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 label and the carton after EXP. The expiry date refers to the last day of that month.
Store below 30 °C.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
To reconstitute CEVENFACTA only use the material provided in the kit.
After reconstitution, the product must be stored in the vial and given within 4 hours.
Any unused solution should be thrown away 4 hours after reconstitution.
Do not use this medicine if you notice the liquid has particles or is cloudy after mixing.
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.
The powder for solution for injection contains: 1 mg/vial (corresponding to 45 KIU/vial), 2 mg/vial (corresponding to 90 KIU/vial), 5 mg/vial (corresponding to 225 KIU/vial).
After reconstitution the solution concentration is approximately 1 mg/ mL (45 KIU/ mL) eptacog beta (activated). 1 KIU equals 1 000 IU (International Units).
The powder vial contains a white to off-white lyophilised powder and the prefilled syringe of solvent contains clear and colourless solution. The reconstituted solution should be clear to slightly opaque.
Each CEVENFACTA pack contains:
Pack sizes: 1 mg (45 KIU), 2 mg (90 KIU), and 5 mg (225 KIU).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised 19th August 2022
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
CEVENFACTA is supplied as a powder. Before injection it must be made up (reconstituted) with the solvent supplied in the syringe. The solvent is water for injections. The reconstituted CEVENFACTA must be injected into your vein (intravenous use only).
This kit provides the equipment needed to reconstitute this medicine. Additional materials are needed to inject the medicine after reconstitution. These materials will be provided by your healthcare professional (e.g., your pharmacist or haemophilia treatment centre).
Your doctor or your nurse will show you and/or your caregiver how to make up and inject CEVENFACTA. Do not use this kit without proper training by your healthcare provider or haemophilia treatment centre.
Use a clean and germ-free (aseptic) technique when preparing and injecting the medicine.
Your CEVENFACTA kit contains:
*NOTE: Your CEVENFACTA kit will contain only one vial adapter.
You will also need a sterile injection set (tubing and butterfly needle), a sterile plastic syringe, sterile alcohol swabs and a sharps container compliant with local applicable regulations and standards. These materials are not included in the CEVENFACTA package. These additional materials will be provided by your healthcare professional (e.g., your pharmacist or haemophilia treatment centre).
1) Collect equipment and prepare vial
Do not use the kit if the tamper seal has been broken or you suspect the kit is contaminated. Use a new kit instead.
Do not use if the expiry date has passed.
Do not use the contents if they have been dropped or if they are damaged. Use a new kit instead.
Do not warm the vial and pre-filled syringe in any other way.
If the plastic cap is loose or missing, do not use the vial.
2) Attach vial adapter
If the protective paper cover is not fully sealed or if it is broken, do not use the vial adapter.
Do not take the vial adapter out of the protective cap with your fingers. If you touch the spike on the vial adapter, you may transfer germs from your fingers onto the spike.
Do not touch the top of the vial adapter once you have removed plastic cover to avoid transferring germs from your fingers.
NOTE: The 5 mg vial adapter may not sit flat against the vial, but it is fully functional. As mentioned previously, your CEVENFACTA kit will contain only one vial adapter: the one suitable for the vial included in the kit.
3) Attach pre-filled syringe and install the plunger rod
Do not touch the syringe tip under the syringe cap to avoid transferring germs from your fingers.
Do not use the pre-filled syringe if the syringe cap is loose or missing.
Be careful not to overtighten as you will need to remove the syringe later.
4) Mix medicinal product in vial
Do not push too quickly as it can result in excess foam and air in the vial.
Do not shake the vial as this creates foam and air.
Do not use the medicinal product if the liquid has particles or is cloudy after mixing. Start over with a new kit.
5) Remove empty syringe from vial adapter
Do not remove the vial adapter.
Do not touch the luer lock top of the vial adapter. If you touch this top, you may transfer germs from your fingers.
6) Mix additional vial(s) and inject dose
Do not use if more than 4 hours have passed since reconstitution.
7) Throw out empty medicinal product vial(s)
Do not throw out with ordinary household waste.
Do not take the vial and vial adapter apart before disposal.
Do not reuse any components of the kit.
Follow local applicable regulations and standards for proper disposal of the sharps container.
CEVENFACTA is supplied in a kit that should be stored below 30 °C.
Do not open the kit contents until you are ready to use them.
Do not freeze or store syringes containing reconstituted CEVENFACTA solution.
Avoid exposure of the reconstituted CEVENFACTA solution to direct light.
CEVENFACTA is only for injection into a vein (intravenous administration). Do not inject in any other way such as below the skin (subcutaneously) or into a muscle (intramuscularly).
Contact your doctor, nurse or pharmacist if you experience problems.