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 04668/0419.
Esperoct powder and solvent for solution for injection
Esperoct 500 IU powder and solvent for solution for injection
Esperoct 1000 IU powder and solvent for solution for injection
Esperoct 1500 IU powder and solvent for solution for injection
Esperoct 2000 IU powder and solvent for solution for injection
Esperoct 3000 IU powder and solvent for solution for injection
turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA))
▼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 Esperoct is and what it is used for
2. What you need to know before you use Esperoct
3. How to use Esperoct
4. Possible side effects
5. How to store Esperoct
6. Contents of the pack and other information
Esperoct contains the active substance turoctocog alfa pegol and is a long-acting recombinant coagulation factor VIII product. Factor VIII is a protein found in the blood that helps to prevent and stop bleeding.
Esperoct is used to treat and prevent bleeding in people 12 years and above with haemophilia A (inborn factor VIII deficiency).
In people with haemophilia A, factor VIII is missing or does not work properly. Esperoct replaces this faulty or missing factor VIII and helps blood to form clots at the site of bleeding.
Do not use Esperoct if either of the above applies to you. If you are not sure, talk to your doctor before using this medicine.
Previous use of factor VIII medicine
Tell your doctor if you have used factor VIII medicines before, especially if you developed inhibitors (antibodies) against the medicine, since there might be a risk that it happens again.
There is a risk that you may experience a severe and sudden allergic reaction (e.g. anaphylactic reaction) to Esperoct.
Stop the injection and contact your doctor or an emergency unit immediately if you have early signs of allergic reactions. These early signs may include rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, or dizziness, headache, nausea and vomiting.
Inhibitors (antibodies) can develop during the treatment with all factor VIII medicines
If you have a catheter where medicines can be injected into your blood (central venous access device), you may develop infections or blood clots at the site of the catheter.
Talk to your doctor or pharmacist if you have heart disease or you are at risk of heart disease.
Esperoct can not be used in children below 12 years of age.
Tell your doctor if you are taking, have recently taken or might take any other 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 taking this medicine.
Esperoct has no influence on your ability to drive and use machines.
This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.
This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
A decreased factor VIII activity may occur in the beginning of your treatment. If you think your medicine works less than expected, tell your doctor.
Treatment with Esperoct will be started by a doctor who is experienced in the care of people with haemophilia A.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure about how to use Esperoct.
Esperoct is given as an injection into a vein (intravenously), see “Instructions on how to use Esperoct” for more information.
Your doctor will calculate your dose for you. This will depend on your body weight and whether it is used to prevent or to treat a bleeding.
Adults and adolescents (12 years of age and above): The recommended dose is 50 IU of Esperoct per kg body weight every 4 days. Your doctor may choose another dose or how often the injections should be given, based on your need.
The dose of Esperoct is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding. If you experience that the effect of Esperoct is insufficient, talk to your doctor.
Adolescents (12 years of age and above) can use the same dose as adults.
If you use more Esperoct than you should, contact your doctor straight away.
If you have to significantly increase your usage of Esperoct to stop a bleed, talk to your doctor immediately. For further information, see “Development of ‘factor VIII inhibitors’ (antibodies)” in section 2.
If you forget a dose, inject the missed dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose. Proceed with the next injection as scheduled and continue as advised by your doctor. If you are in doubt, contact your doctor.
Do not stop using Esperoct without talking to your doctor.
If you stop using Esperoct, you may no longer be protected against bleeding or a current bleed may not stop. 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.
Stop the injection immediately if you develop severe and sudden allergic reactions (anaphylactic reactions). You must contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as:
If you have previously received more than 150 days of treatment with factor VIII, inhibitors (antibodies) may develop (may affect up to 1 in 100 people). If this happens, your medicine may stop working properly and you may experience persistent bleeding. If this happens, you should contact your doctor immediately. See “Development of ‘factor VIII inhibitors’ (antibodies)” in section 2.
Very common side effects (may affect more than up to 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)
Other possible side effects (unknown frequency)
Decreased factor VIII activity in the absence of factor VIII inhibitors.
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 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 after ‘EXP’ on the carton, on the vial, and on the pre-filled syringe labels. The expiry date refers to the last day of that month.
Before reconstitution (before the powder is mixed with the solvent):
Store in a refrigerator (2 °C - 8 °C). Esperoct can be kept
When you start to store Esperoct outside the refrigerator, record the date and the storage temperature in the space provided on the carton.
Once you have taken the product out of the refrigerator for storage you must not store it again in the refrigerator.Do not freeze. Store in the original package in order to protect from light.
After reconstitution (after the powder has been mixed with the solvent):
Once you have reconstituted Esperoct, it should be used immediately. If you cannot use the reconstituted solution immediately, it should be used within
The powder in the vial appears as a white to off-white powder. Do not use the powder if the colour has changed.
The reconstituted solution must be clear and colourless. Do not use the reconstituted solution if you notice any particles or discolouration.
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.
After reconstitution with the supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection), the prepared solution for injection contains 125, 250, 375, 500 or 750 IU turoctocog alfa pegol per mL, respectively (based on the strength of turoctocog alfa pegol, i.e. 500, 1000, 1500, 2000 or 3000 IU).
Esperoct is available in packs containing 500 IU, 1000 IU, 1500 IU, 2000 IU, or 3000 IU. Each pack of Esperoct contains a vial with white to off-white powder, a 4 mL pre-filled syringe with a clear colourless solvent, a plunger rod and a vial adapter.
This leaflet was last revised in 02/2023
Esperoct is supplied as a powder. Before injection, it must be reconstituted with the solvent supplied in the syringe. The solvent is a sodium chloride 9 mg/mL (0.9%) solution for injection. The reconstituted product must be injected into your vein (intravenous (IV) injection). The equipment in this package is designed to reconstitute and inject Esperoct.
You will also need:
These items are not included in the Esperoct package.
Do not use the equipment without proper training from your doctor or nurse.
Always wash your hands and ensure that the area around you is clean.
When you prepare and inject medicine directly into a vein, it is important to use a clean and germ- free (aseptic) technique. An incorrect technique can introduce germs that can infect your blood.
Do not open the equipment until you are ready to use it.
Do not use the equipment if it has been dropped, or if it is damaged. Use a new package instead.
Do not use the equipment if it has expired. Use a new package instead. The expiry date is printed on the outer carton, on the vial, on the vial adapter, and on the pre-filled syringe.
Do not use the equipment if you suspect it is contaminated. Use a new package instead.
Do not dispose of any of the items until after you have injected the reconstituted solution.
The equipment is for single use only.
The package contains:
Do not use any other way to warm the vial and pre-filled syringe.
Do not touch the rubber stopper with your fingers as this can transfer germs.
Once attached, do not remove the vial adapter from the vial.
Do not lift the vial adapter from the vial when removing the protective cap.
Esperoct is recommended to be used immediately after it has been reconstituted.
If you cannot use the reconstituted Esperoct solution immediately, it should be used within:
Store the reconstituted product in the vial.
Do not freeze the reconstituted solution or store it in syringes.
Keep the reconstituted solution out of direct light.
If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Esperoct is now ready to be injected into your vein.
Do not mix Esperoct with any other intravenous injections or medicines.
Injecting Esperoct via needleless connectors for intravenous (IV) catheters
Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections. Some needleless connectors with an internal spike are incompatible with the pre-filled syringe. This incompatibility may prevent administration of the medicine and result in damage to the needleless connector.
Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Do not disassemble the equipment before disposal.
Do not reuse the equipment.