Esperoct 3000 IU powder and solvent for solution for injection: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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
Esperoct 4000 IU powder and solvent for solution for injection
Esperoct 5000 IU powder and solvent for solution for injection

turoctocog alfa pegol [pegylated recombinant human coagulation factor VIII]

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is provided at the end of section 4.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

What Esperoct is and what it is used for
What you need to know before using Esperoct
How to use Esperoct
Possible side effects
How to store Esperoct
Contents of the pack and other information

1. What Esperoct is and what it is used for

What Esperoct is

Esperoct contains the active substance turoctocog alfa pegol and is a recombinant, prolonged-acting coagulation factor VIII. Factor VIII is a protein found in the blood that helps 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 (congenital factor VIII deficiency).

In people with haemophilia A, factor VIII is missing or does not function properly. Esperoct replaces this absent or defective factor VIII and helps the blood form clots at the site of bleeding.

2. What you need to know before using Esperoct

Do not use Esperoct

if you are allergic to turoctocog alfa pegol or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to hamster proteins.

Do not use Esperoct if you are in any of the situations above. If you are unsure, consult your doctor before using this medicine.

Warnings and precautions

Previous use of factor VIII medicines

Inform your doctor if you have previously used factor VIII medicines, especially if you have developed inhibitors (antibodies) against the medicine, as there may be a risk of this happening again.

Allergic reactions

There is a risk of a serious and sudden allergic reaction (e.g., an anaphylactic reaction) to Esperoct.

If you experience early signs of allergic reactions, stop the injection and contact your doctor or emergency services immediately. Early signs may include rash, hives, itching, widespread skin redness and/or swelling of the lips, tongue, face or hands, difficulty swallowing or breathing, wheezing, chest tightness, pale and cold skin, palpitations, dizziness, headache, nausea and vomiting.

Development of “factor VIII inhibitors” (antibodies)

Inhibitors (antibodies) may develop during treatment with all factor VIII medicines.

These inhibitors, especially at high levels, may prevent the treatment from working properly.
You will be closely monitored for the development of inhibitors.
If your bleeding is not controlled with Esperoct, inform your doctor immediately.
Do not increase the total dose of Esperoct to control bleeding without speaking to your doctor.

Catheter-related complications

If you have a catheter used to inject medicines into your bloodstream (a central venous access device), you may develop infections or blood clots at the catheter insertion site.

Heart disease

Talk to your doctor or pharmacist if you have heart disease or are at risk of developing heart disease.

Other medicines and Esperoct

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Esperoct has no influence on the ability to drive or operate machinery.

Decreased factor VIII activity in previously untreated patients

A decrease in factor VIII activity may occur at the beginning of your treatment. If your bleeding is not controlled with Esperoct, inform your doctor.

Decreased factor VIII activity in previously treated patients

A decrease in factor VIII activity may occur at the beginning of your treatment. Inform your doctor if your usual dose of Esperoct does not control your bleeding.

Esperoct contains sodium

This medicine contains 30.5 mg of sodium (main component of table/cooking salt) per reconstituted vial. This is equivalent to 1.5% of the maximum daily recommended sodium intake for an adult.

3. How to use Esperoct

A doctor experienced in treating people with haemophilia A will initiate treatment with Esperoct.

Follow exactly the instructions for administration of this medicine given by your doctor. If you have any doubts about how to use Esperoct, consult your doctor again.

How Esperoct is administered

Esperoct is administered by injection into a vein (intravenous route). See "Instructions for using Esperoct" for more information.

How much to use

Your doctor will calculate your dose based on your body weight and whether it is being used to prevent or to treat bleeding.

To prevent bleeding

For children (under 12 years of age), the recommended dose is 65 IU of Esperoct per kg body weight twice a week. Your doctor may choose a different dose or frequency of injections depending on your needs.

For adults and adolescents (12 years of age or older), the recommended dose is 50 IU of Esperoct per kg body weight every 4 days. Your doctor may choose a different dose or frequency of injections depending on your needs.

To treat bleeding

The dose of Esperoct is calculated based on your body weight and the desired factor VIII levels. The target factor VIII level depends on the severity and location of the bleeding. Inform your doctor if your usual dose of Esperoct is not controlling your bleeding.

Use in children and adolescents

For children (under 12 years of age), the recommended dose is 65 IU of Esperoct per kg body weight twice a week. Adolescents (12 years of age or older) may 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 immediately.

Always use Esperoct exactly as your doctor has instructed. If you are unsure, consult your doctor. For more information, see "Development of factor VIII inhibitors (antibodies)" in section 2.

If you forget to use Esperoct

If you miss a dose, inject the missed dose as soon as you remember. Do not inject a double dose to make up for the missed dose. Continue with the next injection as scheduled and follow your doctor's advice. If you have any doubts, contact your doctor.

If you stop using Esperoct

Do not stop treatment with Esperoct without first talking to your doctor.

If you stop treatment with Esperoct, you will no longer be protected against bleeding, or an existing bleed may not stop. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Allergic reactions (hypersensitivity)

Stop the injection immediately if you develop severe and sudden allergic reactions (anaphylactic reactions). If you experience any of the following symptoms of an allergic reaction, contact your doctor or emergency services immediately:

difficulty swallowing or breathing
wheezing
tightness in the chest
redness and/or swelling of the lips, tongue, face, or hands
rashes, skin eruptions, hives, or itching
pale and cold skin, palpitations, 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, you may develop inhibitors (antibodies) (this may affect up to 1 in 100 people). If this occurs, treatment may cease to work properly and you may experience persistent bleeding. If this happens, contact your doctor immediately. See “Development of factor VIII inhibitors (antibodies)” in section 2.

The following adverse effects have been observed with Esperoct

Very common adverse effects (may affect more than 1 in 10 people)

factor VIII inhibitors (antibodies) in patients who have not been previously treated with factor VIII.

Common adverse effects (may affect up to 1 in 10 people)

skin reactions at the injection site
itching (pruritus)
redness of the skin (erythema)
skin rash.

Uncommon adverse effects (may affect up to 1 in 100 people)

allergic reactions (hypersensitivity). These may become severe and life-threatening; see the previous section “Allergic reactions (hypersensitivity)” for more information
factor VIII inhibitors (antibodies) in patients previously treated with factor VIII.

Other possible adverse effects (frequency not known)

Decrease in factor VIII activity in the absence of factor VIII inhibitors.

An immune system response may occur temporarily at the beginning of treatment, which could reduce the effectiveness of the medicine.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esperoct

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, vial label, and pre-filled syringe label following “EXP”. The expiry date refers to the last day of the month indicated.

Before reconstitution (before mixing the powder with the solvent):

Store in a refrigerator (between 2 °C and 8 °C). Esperoct may be stored

at room temperature (≤ 30 °C) for a single period not exceeding 1 year within the medicine's shelf life or
above room temperature (> 30 °C up to 40 °C) for a single period not exceeding 3 months within the medicine's shelf life.

When you begin storing Esperoct outside the refrigerator, record the date and storage temperature in the space provided on the outer carton.

Once the medicine has been removed from refrigerated storage, it must not be returned to the refrigerator. Do not freeze. Keep in the original packaging to protect from light.

After reconstitution (after mixing the powder with the solvent – 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 3,000 IU):

After reconstitution, Esperoct should be used immediately. If immediate use is not possible, the reconstituted solution may be used within

24 hours when stored in a refrigerator (between 2 °C and 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) for no more than 3 months prior to reconstitution.

After reconstitution (after mixing the powder with the solvent – 4,000 IU, 5,000 IU):

Chemical and physical in-use stability has been demonstrated for:

24 hours when stored in a refrigerator (between 2 °C and 8 °C) or
4 hours at ≤ 30 °C.

The powder in the vial is white to off-white. Do not use if the powder has changed colour.

The reconstituted solution should be clear and colourless. Do not use the reconstituted solution if you observe particles or discoloration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Esperoct

The active substance is turoctocog alfa pegol [pegylated recombinant human coagulation factor VIII]. Each vial of Esperoct contains 500, 1 000, 1 500, 2 000, 3 000, 4 000 or 5 000 IU of turoctocog alfa pegol.
The other components are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
The components of 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 resulting injectable solution contains 125, 250, 375, 500, 750, 1 000 or 1 250 IU of turoctocog alfa pegol per ml, respectively (based on the concentration of turoctocog alfa pegol, i.e., 500, 1 000, 1 500, 2 000, 3 000, 4 000 or 5 000 IU).

Appearance of Esperoct and contents of the pack

Esperoct is available in packs containing 500 IU, 1 000 IU, 1 500 IU, 2 000 IU, 3 000 IU, 4 000 IU or 5 000 IU. Each pack of Esperoct contains one vial with a white to off-white powder, one pre-filled syringe with 4 ml of a colourless and clear solvent, one plunger rod and one vial adapter.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Esperoct Instructions for Use

Read these instructions carefully before using Esperoct.

Esperoct is supplied as a powder. Before injection, it must be reconstituted with the solvent provided in the syringe. The solvent is an injectable solution of sodium chloride 9 mg/ml (0.9%). The reconstituted medicine should be injected into a vein [intravenous (IV) injection]. The components in this package are designed to reconstitute and inject Esperoct.

You will also need:

an infusion set (with butterfly needle and tubing)
sterile alcohol wipes
gauze and adhesive bandages.

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 the area around you is clean.

When preparing and injecting the medicine directly into a vein, it is important to use a clean, germ-free (aseptic) technique. Incorrect technique may introduce germs that can infect the bloodstream.

Do not open the equipment until you are ready to use it.

Do not use the equipment if it has been dropped or damaged. Use a new package instead.

Do not use the equipment if it has expired. Use a new package instead. The expiration date is printed on the outer packaging, vial, vial adapter, and pre-filled syringe.

Do not use the equipment if you suspect it is contaminated. Use a new package instead.

Do not discard any components until the reconstituted solution has been injected.

The equipment is for single use only.

Contents

The package contains:

1 vial of Esperoct powder
1 vial adapter
1 pre-filled syringe with solvent
1 plunger rod (located beneath the syringe)

Diagram of a vial of Esperoct powder showing the plastic cap and underlying rubber stopper

Diagram of a vial adapter with protective cover, spike under the protective sheet, and the protective sheet itself in blue on a white background

Diagram of a pre-filled syringe with labels indicating tip, cap, graduated scale, and plunger on a white background

Technical diagram of a syringe with labels indicating the barrel on the left side and the

Prepare the vial and syringe

Prepare the number of Esperoct packages you need.

Check the expiration date.

Verify the name, concentration, and color of the package to confirm it contains the correct medicine.

Wash your hands and dry them thoroughly with a clean towel or air dry.

Remove the vial, vial adapter, and pre-filled syringe from the package. Leave the plunger rod untouched in the package.

Bring the vial and pre-filled syringe to room temperature by holding both in your hands until they feel the same temperature as your hands; see Figure A.

Do not use any other method to warm the vial and pre-filled syringe.

Two hands holding respectively a vial and a syringe with needle to prepare the

Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial.

Clean the rubber stopper with a sterile alcohol wipe and allow it to air dry for a few seconds before use to ensure it is as germ-free as possible.

Do not touch the rubber stopper with your fingers, as this may transfer germs.

A hand holding a small glass medicine vial with a blue arrow pointing toward the

Attach the vial adapter

Remove the protective paper from the vial adapter.

If the protective paper is not fully sealed or is torn, do not use the vial adapter.

Do not remove the vial adapter from its protective cover with your fingers.

Touching the spike of the vial adapter may transfer germs from your fingers.

Two hands lifting and separating with an upward movement

Place the vial on a flat, hard surface.

Turn the protective cover upside down and press the vial adapter firmly onto the vial.

Once attached, do not remove the vial adapter from the vial.

A hand pressing a protective cap downward onto a small glass vial to seal or open it, with a blue arrow pointing downward

Gently squeeze the protective cover between your thumb and index finger as shown.

Remove the protective cover from the vial adapter.

Do not remove the vial adapter when removing the protective cover.

A hand vertically lifting a transparent cap from a medication vial following the direction indicated by a blue arrow

Assemble the plunger rod and syringe

Grasp the plunger rod by the wide end and remove it from the package. Do not touch the sides or threads of the plunger rod. Touching them may transfer germs from your fingers.

Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.

Two hands holding a syringe and rotating the device with a curved arrow indicating the rotational movement

Remove the syringe cap by bending it downward until the perforation breaks.

Do not touch the tip of the syringe below the syringe cap. Touching the tip may transfer germs from your fingers.

If the syringe cap is loose or missing, do not use the pre-filled syringe.

Two hands separating or joining two components of a medical device with a curved blue arrow indicating the movement to perform

Screw the pre-filled syringe firmly into the vial adapter until resistance is felt.

Two hands holding a cylindrical medical device and rotating it clockwise following the direction of a blue curved arrow

Reconstitute the powder with the solvent

Hold the pre-filled syringe at a slight angle with the vial pointing downward.

Push the plunger rod to inject all the solvent into the vial.

A hand holding an angled syringe and pressing the plunger downward to expel liquid through the

Keep the plunger rod pressed and gently swirl the vial until the powder is completely dissolved.

Do not shake the vial, as this may cause foaming.

Inspect the reconstituted solution. It should be clear and colorless with no visible particles. If you see particles or a color change, do not use it. Use a new package instead.

A hand holding a syringe vertically and rotating it following the direction of a circular blue arrow pointing downward

Esperoct is recommended to be used immediately after reconstitution.

If you cannot use the reconstituted Esperoct solution immediately (applies to 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU), it must be used within:

24 hours when stored in the refrigerator (between 2°C and 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 to 40°C) for up to 3 months prior to reconstitution.

If you cannot use the reconstituted Esperoct solution immediately (applies to 4000 IU, 5000 IU), it must be used within:

24 hours when stored in the refrigerator (between 2°C and 8°C), or
4 hours (≤ 30°C)

Store the reconstituted medicine in the vial.

Do not freeze the reconstituted solution or store it in syringes.

Keep the reconstituted solution away from direct light.

If your dose requires more than one vial, repeat steps A through J with additional vials, vial adapters, and pre-filled syringes until the required dose is reached.

Keep the plunger rod fully pushed in.

Turn the syringe and vial upside down.

Stop pushing the plunger rod and allow it to retract on its own as the reconstituted solution fills the syringe.

Gently pull the plunger rod downward to draw the reconstituted solution into the syringe.

If you do not need to use all the reconstituted medicine from the vial, use the syringe scale to withdraw the dose prescribed by your doctor or nurse.

If air is present in the syringe at any time, inject the air back into the vial.

While holding the vial upside down, gently tap the syringe to allow any bubbles to rise to the top.

Slowly push the plunger rod until all bubbles are expelled.

A hand holding a syringe vertically with a blue arrow pointing downward indicating the plunger depression movement

Unscrew the vial adapter from the vial.

Do not touch the tip of the syringe. Touching it may transfer germs from your fingers.

Two hands rotating a transparent protector downward to attach a cylindrical medical device on a light blue background with a curved arrow

Inject the reconstituted solution

Esperoct is now ready to be injected into a vein.

Inject the reconstituted solution according to your doctor’s or nurse’s instructions.
Administer slowly over approximately 2 minutes.

Do not mix Esperoct with other injections or intravenous medications.

Injection of Esperoct through 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 internal spikes are incompatible with the pre-filled syringe. This incompatibility may prevent medication delivery and may damage the needleless connector.

Injection of the solution through a central venous access device (CVAD), such as a central venous catheter or subcutaneous port:

Use a clean, germ-free (aseptic) technique. Follow instructions for proper use of your connector and CVAD with guidance from your doctor or nurse.
Injection into a CVAD may require using a sterile 10 ml plastic syringe to withdraw the reconstituted solution. This should be done immediately after step J.
If flushing the CVAD line is required before or after injecting Esperoct, use sodium chloride 9 mg/ml (0.9%) injectable solution.

Disposal

After injection, safely dispose of all unused Esperoct solution, the syringe with the intravenous infusion set, the vial with the vial adapter, and all other waste according to your pharmacist’s instructions.

Do not throw them in household trash.

Medical diagram showing a syringe with a flexible tube being inserted into a medication vial via a blue arrow

Do not disassemble the equipment before disposal.

Do not reuse the equipment.