Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Esperoct 2000 IU powder and solvent for solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Turoctocog alfa pegol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Esperoct is 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. What Esperoct is used for Esperoct is used to treat and prevent bleeding in people of all age groups 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.
2.
What you need to know before you take it
e Esperoct
Do not use Esperoct • if you are allergic to the turoctocog alfa pegol or to any of the other ingredients of this medicine (listed in section 6) • if you are allergic to hamster proteins.
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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. Warnings and precautions 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. Allergic reactions 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. Development of 'factor VIII inhibitors' (antibodies) Inhibitors (antibodies) can develop during the treatment with all factor VIII medicines • These inhibitors, especially at high levels, stop the treatment working properly • You will be monitored carefully for development of these inhibitors • If your bleeding is not being controlled with Esperoct, tell your doctor immediately • Do not increase the total dose of Esperoct to control your bleed without talking to your doctor. Catheter-related problems 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. Heart disease Talk to your doctor or pharmacist if you have heart disease or you are at risk of heart disease.
Other medicines and Esperoct Tell your doctor if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding 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. Driving and using machines Esperoct has no influence on your ability to drive and use machines. Decreased factor VIII activity in previously untreated patients A decreased factor VIII activity may occur in the beginning of the treatment. If a bleeding is not being controlled with Esperoct, talk to the treating doctor immediately. Decreased factor VIII activity in previously treated patients A decreased factor VIII activity may occur in the beginning of your treatment. Talk to your doctor if your bleeding is not being controlled with your usual dose of Esperoct. Esperoct contains sodium 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.
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3.
How to use Esperoct
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.
How to take it
Esperoct is given as an injection into a vein (intravenously), see "Instructions on how to use Esperoct" for more information. How much to use 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. To prevent bleeding For children (below 12 years of age), the recommended dose is 65 IU of Esperoct per kg body weight twice weekly. Your doctor may choose another dose or how often the injections should be given, based on your need. For 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. To treat bleeding 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. Talk to your doctor if your bleeding is not being controlled with your usual dose of Esperoct. Use in children and adolescents For children (below 12 years of age), the recommended dose is 65 IU of Esperoct per kg body weight twice weekly. Adolescents (12 years of age and above) can use the same dose as adults. If you use more Esperoct than you should If you use more Esperoct than you should, contact your doctor straight away. Always use Esperoct exactly as your doctor has told you. You should check with your doctor if you are not sure. For further information, see "Development of 'factor VIII inhibitors' (antibodies)" in section 2. If you forget to use Esperoct 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. If you stop using Esperoct 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.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions (hypersensitivity) 3
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: • difficulty in swallowing or breathing • wheezing • chest tightness • redness and/or swelling of the lips, tongue, face or hands • rash, hives, weals or itching • pale and cold skin, fast heartbeat, or dizziness (low blood pressure) • headache, feeling sick (nausea) or being sick (vomiting). Development of 'factor VIII inhibitors' (antibodies) 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. The following side effects have been observed with Esperoct Very common side effects (may affect more than up to 1 in 10 people) • factor VIII inhibitors (antibodies) in patients not previously treated with factor VIII. Common side effects (may affect up to 1 in 10 people) • skin reactions where the injection is given • itching (pruritus) • redness of skin (erythema) • rash. Uncommon side effects (may affect up to 1 in 100 people)
- allergic reactions (hypersensitivity). These may become severe and could be life-threatening, see "Allergic reactions (hypersensitivity)" above for more information
- factor VIII inhibitors (antibodies) in patients previously treated with factor VIII. Other possible side effects (unknown frequency) Decreased factor VIII activity in the absence of factor VIII inhibitors. A temporary response from your immune system might occur in the beginning of your treatment, which could make your medicine work less well. Reporting of side effects 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: https://yellowcard.mhra.gov.uk 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 it
Esperoct
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, on the vial, and on the pre-filled syringe labels after 'EXP'. The expiry date refers to the last day of that month. Before reconstitution (before the powder is mixed with the solvent): 4
Store in a refrigerator (2 °C – 8 °C). Esperoct can be kept • at room temperature (≤30 °C) for a single period for up to 1 year within the shelf life of the product or • above room temperature (>30 °C up to 40 °C) for a single period for up to 3 months within the shelf life of the product. 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 – 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU): Once you have reconstituted Esperoct, it should be used immediately. If you cannot use the reconstituted solution immediately, it should be used within • 24 hours when stored in a refrigerator (2 °C – 8 °C) or • 4 hours at ≤30 °C or • 1 hour between >30 °C and 40 °C, only if the product was stored above room temperature (>30 °C up to 40 °C) before reconstitution for no longer than 3 months. After reconstitution (after the powder has been mixed with the solvent – 4 000 IU, 5 000 IU): Chemical and physical inuse stability have been demonstrated for:
- 24 hours when stored in a refrigerator (2 °C – 8 °C) or
- 4 hours at ≤ 30 °C. 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.
6.
Contents of the pack and other information
What Esperoct contains • The active substance is turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA)). Each vial of Esperoct contains nominally 500, 1000, 1500, 2000, 3000, 4000 or 5000 IU turoctocog alfa pegol. • The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid. • The ingredients in the solvent are sodium chloride 9 mg/mL (0.9%) solution for injection and water for injections. See section 2 "Esperoct contains sodium". 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, 750, 1000 or 1250 IU turoctocog alfa pegol per mL, respectively (based on the strength of turoctocog alfa pegol, i.e. 500, 1000, 1500, 2000, 3000, 4000 or 5000 IU). What Esperoct looks like and contents of the pack Esperoct is available in packs containing 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU, 4000 IU or 5000 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. 5
Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Denmark This leaflet was last revised in 11/2024
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Instructions on how to use Esperoct Read these instructions carefully before using Esperoct. 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: • an infusion set (butterfly needle with tubing) • sterile alcohol swabs • gauze pads and plasters. 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. Contents The package contains: • 1 vial with Esperoct powder • 1 vial adapter • 1 pre-filled syringe with solvent • 1 plunger rod (placed under the syringe)
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Overview Vial with Esperoct powder
Plastic cap Rubber stopper (under plastic cap)
Vial adapter Protective cap
Spike Protective (under protective paper) paper
Pre-filled syringe with solvent
Syringe tip (under syringe cap) Scale
Plunger
Syringe cap
Plunger rod
Thread
Wide top end
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1. Prepare the vial and the syringe
A
•
Take out the number of Esperoct packages you need.
•
Check the expiry date.
•
Check the name, strength and colour of the package to make sure it contains the correct product.
•
Wash your hands and dry them properly using a clean towel or let them air dry.
•
Take the vial, the vial adapter and the pre-filled syringe out of the carton. Leave the plunger rod untouched in the carton.
•
Bring the vial and the pre-filled syringe to room temperature. You can do this by holding them in your hands until they feel as warm as your hands, see figure A. Do not use any other way to warm the vial and pre-filled syringe.
•
Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial.
•
Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ-free as possible.
B
Do not touch the rubber stopper with your fingers as this can transfer germs. 2. Attach the vial adapter •
C
Remove the protective paper from the vial adapter. If the protective paper 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, germs from your fingers can be transferred.
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•
Place the vial on a flat and solid surface.
•
Turn over the protective cap, and snap the vial adapter onto the vial.
D
Once attached, do not remove the vial adapter from the vial.
•
Lightly squeeze the protective cap with your thumb and index finger as shown.
•
Remove the protective cap from the vial adapter.
E
Do not lift the vial adapter from the vial when removing the protective cap.
3. Attach the plunger rod and the syringe
F
•
Grasp the plunger rod by the wide top end and take it out of the carton. Do not touch the sides or the thread of the plunger rod. If you touch the sides or the thread, germs from your fingers can be transferred.
•
Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
•
Remove the syringe cap from the pre-filled syringe by bending it down until the perforation breaks.
G
Do not touch the syringe tip under the syringe cap. If you touch the syringe tip, germs from your fingers can be transferred. If the syringe cap is loose or missing, do not use the pre-filled syringe. •
Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
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H
4. Reconstitute the powder with the solvent
I
•
Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
•
Push the plunger rod to inject all the solvent into the vial.
•
Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
J
Do not shake the vial as this will cause foaming. •
Check the reconstituted solution. It must be clear and colourless and no particles should be visible. If you notice particles or discolouration, do not use it. Use a new package instead.
Esperoct is recommended to be used immediately after it has been reconstituted. If you cannot use the reconstituted Esperoct solution immediately (applies to 500 IU, 1 000 IU, 1 500 IU, 2 000 IU, 3 000 IU), it should be used within: • 24 hours when stored in a refrigerator (2 °C – 8 °C) or • 4 hours (≤30 °C) or • 1 hour between >30 °C and 40 °C, only if the product was stored above room temperature (>30 °C up to 40 °C) before reconstitution for no longer than 3 months. If you cannot use the reconstituted Esperoct solution immediately (applies to 4 000 IU, 5 000 IU), it should be used within: • 24 hours when stored in a refrigerator (2 °C – 8 °C) or • 4 hours (≤ 30 °C).
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.
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•
Keep the plunger rod pushed completely in.
•
Turn the syringe with the vial upside down.
•
Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
•
Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
•
If you do not need to use all of the reconstituted medicine from the vial, use the scale on the syringe to withdraw the dose you need, as instructed by your doctor or nurse.
K
If, at any point, there is air in the syringe, inject the air back into the vial. •
While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
•
Push the plunger rod slowly until all air bubbles are gone.
•
Unscrew the vial adapter with the vial.
L
Do not touch the syringe tip. If you touch the syringe tip, germs from your fingers can be transferred.
5. Inject the reconstituted solution Esperoct is now ready to be injected into your vein. • Inject the reconstituted solution as instructed by your doctor or nurse. • Inject slowly over approximately 2 minutes. 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:
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• • •
Use a clean and germ-free (aseptic) technique. Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse. Injecting into a CVAD may require using a sterile 10 mL plastic syringe for withdrawal of the reconstituted solution. This should be done right after step J. If the CVAD line needs to be flushed before or after the injection of Esperoct, use sodium chloride 9 mg/mL (0.9%) solution for injection.
Disposal •
M
After injection, safely dispose of all unused Esperoct solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist. Do not throw it out with the ordinary household waste.
Do not disassemble the equipment before disposal. Do not reuse the equipment.
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Frequently asked questions about Esperoct 2000 IU powder and solvent for solution for injection
How do I take Esperoct 2000 IU powder and solvent for solution for injection?
Esperoct 2000 IU powder and solvent for solution for injection comes as injection containing 2000iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Esperoct 2000 IU powder and solvent for solution for injection?
The active substance in Esperoct 2000 IU powder and solvent for solution for injection is turoctocog alfa pegol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Esperoct 2000 IU powder and solvent for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Esperoct 2000 IU powder and solvent for solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: turoctocog alfa pegol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Esperoct can be used for all age groups.
4.2. Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Treatment monitoring
During the course of treatment, appropriate determination of factor VIII activity levels is advised to guide adjustments of the dosing regimen of Esperoct, if needed. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and incremental recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients. In the case of major surgical interventions, monitoring of the factor VIII substitution therapy by measurement of plasma factor VIII activity is necessary.
The factor VIII activity of Esperoct can be measured using the conventional factor VIII assays, the chromogenic assay and the one-stage assay.
When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
When using a one-stage clotting assay some silica based reagents should be avoided as they cause underestimation. Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Posology
The dose, dosing interval and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding, on the targeted factor VIII activity level and the patient's clinical condition. The number of units of factor VIII administered is expressed in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products. The activity of factor VIII in plasma is expressed either as percentage (relative to normal human plasma level) or in International Units per dL (relative to the current International Standard for factor VIII in plasma).
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of human plasma.
On demand treatment and treatment of bleeding episodes
The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL.
The required dose is determined using the following formula:
Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Guidance for the dosing of Esperoct for the on-demand treatment and treatment of bleeding episodes is provided in table 1. Plasma factor VIII activity levels should be maintained at or above the described plasma levels (in IU per dL or % of normal). For treatment of bleeds a maximum single dose of Esperoct at 75 IU/kg and a maximum total dose of 200 IU/kg/24 hours may be administered.
Table 1 Guidance for treatment of bleeding episodes with Esperoct
Degree of haemorrhage
Factor VIII level required (IU/dL or % of normal)a
Frequency of doses (hours)
Duration of therapy
Mild
Early haemarthrosis, mild muscle bleeding or mild oral bleeding
20-40
12-24
Until the bleeding is resolved
Moderate
More extensive haemarthrosis, muscle bleeding, haematoma
30-60
12-24
Until the bleeding is resolved
Severe or life-threatening haemorrhages
60-100
8-24
Until the threat is resolved
a The required dose is determined using the following formula:
Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
Perioperative management
The dose level and dosing intervals for surgery depend on the procedure and local practice. A maximum single dose of Esperoct at 75 IU/kg and a maximum total dose of 200 IU/kg/24 hours may be administered.
The frequency of doses and duration of therapy should always be individually adjusted based on individual clinical response.
Table 2 includes general recommendation for dosing of Esperoct for perioperative management. Consideration should be given to maintain a factor VIII activity at or above the target range.
Table 2 Guidance for dosing of Esperoct for perioperative management
Type of surgical procedure
Factor VIII level required (%) (IU/dL)a
Frequency of doses (hours)
Duration of therapy
Minor surgery
Including tooth extraction
30-60
Within one hour before surgery
Repeat after 24 hours if necessary
Single dose or repeat injection every 24 hours for at least 1 day until healing is achieved
Major surgery
80-100
(pre- and post-operative)
Within one hour before surgery to achieve factor VIII activity within the target range
Repeat every 8 to 24 hours to maintain factor VIII activity within the target range
Repeat injection every 8 to 24 hours as necessary until adequate wound healing is achieved
Consider to continue therapy for another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL)
a The required dose is determined using the following formula:
Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
Prophylaxis
The recommended dose for adults is 50 IU of Esperoct per kg body weight every 4 days.
Adjustments of doses and administration intervals may be considered based on achieved factor VIII levels and individual bleeding tendency.
Paediatric population
The recommended dose in adolescents (12 years and above) is the same as for adults.
The recommended dose for prophylaxis in children below 12 years is 65 IU per kg body weight (50-75 IU/kg) administered twice weekly. Adjustments of doses and administration intervals may be considered based on achieved factor VIII levels and individual bleeding tendency.
For more details on paediatrics, see sections 4.4, 5.1 and 5.2.
Method of administration
Esperoct is for intravenous use.
Esperoct should be administered by intravenous injection (over approximately 2 minutes) after reconstitution of the powder with 4 mL supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection).
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Known allergic reaction to hamster protein.
4.4. Special warnings and precautions for use
Traceability
In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity
Allergic-type hypersensitivity reactions are possible with Esperoct. The product contains traces of hamster proteins, which in some patients may cause allergic reactions. If symptoms of hypersensitivity occur, patients should be advised to immediately discontinue the use of the medicinal product and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
In case of shock, standard medical treatment for shock should be implemented.
Inhibitors
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII pro-coagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay. The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon.
The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Decreased factor VIII activity in previously treated patients
From post marketing reports, a decreased factor VIII activity in the absence of detectable factor VIII inhibitors has been reported in previously treated patients (PTPs). The decreased factor VIII activity was observed at time of switching to Esperoct and may, in some cases, have been associated with anti-PEG antibodies. Appropriate determination of factor VIII activity upon switching should be considered.
See section 4.8 for additional information.
Cardiovascular events
In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Catheter-related complications
If a central venous access device (CVAD) is required, the risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Paediatric population
The listed warnings and precautions apply both to adults and children.
Decreased factor VIII incremental recovery in previously untreated patients
In 31 out of 59 previously untreated patients (PUPs), decreased factor VIII incremental recovery (IR) has been observed in the absence of detectable factor VIII inhibitors in clinical trials. Out of these, 14 patients had only a single measurement of low IR, while 17 patients had 2 or more consecutively low IRs occurring within 5 to 10 EDs. Decreased IR was temporary and returned to > 0.6 (IU/dL)/(IU/kg) between 15 to 70 EDs. The decreased IR was observed with increasing anti-PEG IgG titers in PUPs without inhibitors to factor VIII. Consecutive low IR could potentially be associated with reduced efficacy during this time period. Monitoring of paediatric patients, including monitoring of post dose factor VIII activity, is recommended. If a bleeding is not controlled with the recommended dose of Esperoct and/or the expected Factor VIII activity levels are not attained in the absence of FVIII inhibitors, consider adjusting the dose, dosing frequency or discontinuing the product.
Excipient-related considerations
This medicinal product contains 30.5 mg sodium per reconstituted vial, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
4.6. Fertility, pregnancy and lactation
Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
4.7. Effects on ability to drive and use machines
Esperoct has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Esperoct. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre is contacted.
Tabulated list of adverse reactions
The frequencies of adverse reactions as observed across six clinical studies in a total of 270 PTPs and 81 PUPs with severe haemophilia A (<1% endogenous factor VIII activity) and no history of inhibitors are listed in table 3. The categories of adverse reactions presented in table 3 is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000); not known (cannot be estimated from the available data).
Table 3 Frequency of adverse drug reactions in clinical studies
System Organ Class
Preferred term
Frequency (PTPs)
Frequency (PUPs)
Blood and lymphatic system disorders
Factor VIII inhibition*
Uncommon
Very common**
Skin and subcutaneous tissue disorders
Pruritus
Common
-
Eythema
Common
Common
Rash
Common
Common
General disorders and administration site conditions
Injection site reaction***
Common
Common
Immune system disorders
Drug hypersensitivity
-
Common
Hypersensitivity
Uncommon
-
Investigations
Coagulation factor VIII level decreased
Not known****
-
* The confirmed factor VIII inhibitor patient was identified by an initial inhibitor test result of ≥ 0.6 Bethesda units (BU) confirmed in a second sample taken no more than 2 weeks later.
** Covering confirmed factor VIII inhibitor patients in patients at risk (with at least 10 exposure days).
*** Preferred terms included in injection site reactions: Injection site reaction, Vessel puncture site haematoma, Infusion site reaction, Injection site erythema, Injection site rash, Vessel puncture site pain, and Injection site swelling.
**** Based on post marketing reports.
Description of selected adverse reactions
Factor VIII inhibitors
One confirmed case of factor VIII inhibitor occurred in an 18 year-old previously treated patient on prophylactic treatment with Esperoct. The patient had a factor VIII gene intron 22 inversion and was at a high risk of developing factor VIII inhibitors.
There is no indication of an increased risk of factor VIII inhibitor development with treatment of Esperoct as compared to other factor VIII products.
Anti-drug antibodies
There was one case of persistent anti-drug antibodies concomitant with the confirmed case of factor VIII inhibitors (see Factor VIII inhibitors above). Three patients had transiently positive test results for anti-drug antibodies after administration of Esperoct but no correlation with adverse events could be established.
Anti-PEG antibodies
During the clinical study programme, thirty-seven patients had pre-existing anti-PEG antibodies before administration of Esperoct. Twenty of the 37 patients were negative for anti-PEG antibodies post administration of Esperoct. Seventeen patients developed transient low titre anti-PEG antibodies. No correlation with adverse events could be established.
From post-marketing reporting, occurrence of anti-PEG-antibodies has also been observed at time of switching to Esperoct. In some patients anti-PEG antibodies may have been associated with lower than expected level of FVIII activity.
Paediatric population
No difference in the safety profile was observed between previously treated children and adult patients.
In some PUPs, temporary decreased factor VIII IR has been observed in the absence of detectable factor VIII inhibitors (see section 4.4 for more details).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No symptoms of overdose with recombinant coagulation factor VIII have been reported.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ESPEROCT 1500 UI prescriptionTUROCTOCOG ALFA PEGOL · injection / infusion
- ESPEROCT 2000 UI prescriptionTUROCTOCOG ALFA PEGOL · injection / infusion
- ESPEROCT 3000 UI prescriptionTUROCTOCOG ALFA PEGOL · injection / infusion
- ESPEROCT 500 UI prescriptionTUROCTOCOG ALFA PEGOL · injection / infusion
- ESPEROCT 1000 UI prescriptionTUROCTOCOG ALFA PEGOL · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
💬 Ask about this leaflet
Ask anything about Esperoct 2000 IU powder and solvent for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.