Introduction

Label: information for the user

Esperoct 500UI powder and solvent for injectable solution

Esperoct 1000UI powder and solvent for injectable solution

Esperoct 1500UI powder and solvent for injectable solution

Esperoct 2000UI powder and solvent for injectable solution

Esperoct 3000UI powder and solvent for injectable solution

Esperoct 4000UI powder and solvent for injectable solution

Esperoct 5000UI powder and solvent for injectable solution

turoctocogalfapegol [factorVIII of human coagulation pegylated (ADNr)]

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to use this medicine, as it contains important information for you.

–Keep this label, as you may need to refer to it again.

–If you have any questions, consult your doctor.

–This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

–If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

1.What is Esperoct and what it is used for

2.What you need to know before starting to use Esperoct

3.How to use Esperoct

4.Possible adverse effects

5.Storage of Esperoct

6.Contents of the package and additional information

1. What is Esperoct and what is it used for

What is Esperoct

Esperoct contains the active ingredient turoctocogalfapegol and is a recombinant factorVIII of coagulation with prolonged action. FactorVIII is a protein found in the blood that helps prevent and stop bleeding.

What is Esperoct used for

Esperoct is used to treat and prevent bleeding in people of all age groups with hemophiliaA (congenital deficiency of factorVIII).

In people with hemophiliaA, factorVIII is lacking or does not function correctly. Esperoct replaces this absent or defective factorVIII and helps the blood form clots at the bleeding site.

2. What you need to know before starting to use Esperoct

Do not use Esperoct

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

•if you are allergic to hamster proteins.

Do not use Esperoct if you are in any of the above situations. 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 severe and sudden allergic reaction (e.g., anaphylaxis) to Esperoct.

If you experience early signs of allergic reactions, stop the injection and contact your doctor or emergency services immediately. These early signs may include rash, hives, itching in wide areas of the skin, redness and/or swelling of the lips, tongue, face, or hands, difficulty swallowing or breathing, wheezing, chest tightness, pale and cold skin, palpitations, or 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, prevent the treatment from working correctly

•You will be closely monitored for the development of inhibitors

•If your bleeding is not being controlled with Esperoct, inform your doctor immediately

•Do not increase the total dose of Esperoct to control bleeding without consulting your doctor.

Complications related to the catheter

If you have a catheter through which medicines are injected into your blood (a central venous access device), you may develop infections or blood clots at the catheter insertion site.

Heart disease

Speak with 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 using, have used recently, or may need to use any other medicine.

Pregnancy and breastfeeding

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

Driving and operating machinery

The influence of Esperoct on your ability to drive and operate machinery is none.

Decreased factor VIII activity in previously untreated patients

There may be a decrease in factor VIII activity at the start of your treatment. If your bleeding is not being controlled with Esperoct, inform your doctor.

Decreased factor VIII activity in previously treated patients

There may be a decrease in factor VIII activity at the start of your treatment. Inform your doctor if your usual dose of Esperoct is not controlling your bleeding.

Esperoct contains sodium

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

3. How to use Esperoct

A healthcare professional with experience in treating people with hemophilia will initiate treatment with Esperoct.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you are unsure about how to use Esperoct, consult your doctor again.

How to administer Esperoct

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 for preventing or treating a bleed.

For preventing bleeds

For children (under 12 years of age), the recommended dose is 65 UI of Esperoct per kg of body weight twice a week. Your doctor may choose another dose or the frequency at which injections should be administered, according to your needs.

For adults and adolescents (12 years of age or older), the recommended dose is 50 UI of Esperoct per kg of body weight every 4 days. Your doctor may choose another dose or the frequency at which injections should be administered, according to your needs.

For treating bleeds

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

Use in children and adolescents

For children (under 12 years of age), the recommended dose is 65 UI of Esperoct per kg of 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 as your doctor has instructed. If you are unsure, consult your doctor. For more information, see “Development of inhibitors to factor VIII (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 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 interrupt treatment with Esperoct

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

If you interrupt treatment with Esperoct, you will no longer be protected against bleeding or it is possible that an existing bleed will not stop. If you have any other doubts about the use of this medication, ask your doctor.

4. Possible Adverse Effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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
Chest tightness
Redness and/or swelling of the lips, tongue, face, or hands
Rashes, hives, or itching
Pale and cold skin, palpitations, or dizziness (low blood pressure)
Headache, feeling sick (nausea) or vomiting.

Development of “factor VIII inhibitors” (antibodies)

If you have received more than 150 days of treatment with factor VIII previously, you may develop inhibitors (antibodies) (this can affect up to 1 in 100 people). If this happens, the treatment may not 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 side effects have been observed with Esperoct

Very common side effects(can affect more than 1 in 10 people)

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

Common side effects(can affect up to 1 in 10 people)

•Reactions at the injection site

•Itching (pruritus)

•Redness of the skin (erythema)

•Hives.

Uncommon side effects(can affect up to 1 in 100 people)

•Allergic reactions (hypersensitivity). These can be severe and life-threatening, see the previous section “Allergic reactions (hypersensitivity)” for more information

•Factor VIII inhibitors (antibodies) in patients treated previously with factor VIII.

Other possible side effects(unknown frequency)

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

A temporary immune system response may occur at the start of treatment, which can reduce the effectiveness of the medicine.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Esperoct

Keep this medication out of the reach and sight of children.

Do not use this medication after the expiration date that appears on the packaging and on the vial and pre-filled syringe labels after “CAD”. The expiration date is the last day of the month indicated.

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

Store in the refrigerator (between 2°Cand8°C). Esperoct can be stored

•at room temperature (≤30°C) for a single period not exceeding 1year during the validity period of the medicationor

•above room temperature (>30°C to 40°C) for a single period not exceeding 3months during the validity period of the medication.

When you start storing Esperoct outside the refrigerator, note the date and storage temperature on the provided space on the carton packaging.

Once you have removed the medication from the refrigerator for storage, you cannot put it back in the refrigerator. Do not freeze. Store in the original packaging to protect it from light.

After reconstitution(after mixing the powder with the solvent – 500UI, 1000UI, 1500UI, 2000UI, 3000UI):

Once Esperoct has been reconstituted, itmust be used immediately. If you cannot use the reconstituted solution immediately, it should be used in

•24hours when stored in the refrigerator (between 2°Cand8°C)or

•4hours at≤30°Cor

•1hour between ?30°C and 40°C, only if the product has been stored before reconstitution above room temperature (?30°C to 40°C) for no more than 3months.

After reconstitution(after mixing the powder with the solvent – 4000UI, 5000UI):

Chemical and physical stability in use has been demonstrated for:

•24hours when stored in the refrigerator (between 2°C and 8°C)or

•4hours at≤30°C.

The powder in the vial is a white to off-white powder. If the powder color has changed, do not use it.

The reconstituted solution must be transparent and colorless. Do not use the reconstituted solution if you observe particles or discoloration.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Esperoct

•The active ingredient is turoctocogalfapegol [human coagulation factor VIII pegylated (ADNr)]. Each vial of Esperoct contains 500, 1000, 1500, 2000, 3000, 4000 or 5000UI of turoctocogalfapegol.

•The other components are L‑histidine, sucrose, polisorbate80, sodium chloride, L‑methionine, dihydrate calcium chloride, sodium hydroxide, and hydrochloric acid.

•The components of the solvent are injectable solution of sodium chloride 9mg/ml (0.9%) and water for injectable preparations.

See section 2 “Esperoct contains sodium”.

After reconstitution with the supplied solvent [injectable solution of sodium chloride 9mg/ml (0.9%)], the prepared injectable solution contains 125, 250, 375, 500, 750, 1000 or 1250UI of turoctocogalfapegol per ml, respectively (based on the concentration of turoctocogalfapegol, that is, 500, 1000, 1500, 2000, 3000, 4000 or 5000UI).

Appearance of Esperoct and contents of the package

Esperoct is available in packages containing 500UI, 1000UI, 1500UI, 2000UI, 3000UI, 4000UI or 5000UI. Each package of Esperoct contains a vial with white to off-white powder, a pre-filled syringe with 4ml of a colorless and transparent solvent, a plunger rod, and a vial adapter.

Holder of the marketing authorization and responsible for manufacturing

Novo Nordisk A/S

Novo Allé

DK‑2880 Bagsværd, Denmark

Date of the last review of this leaflet:

Other sources of information

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

Instructions for use of Esperoct

Read these instructions carefully before using Esperoct.

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

You will also need:

•a perfusion set (needle with hub and tubing)

•sterile alcohol wipes

•gauze and bandages.

These items are not included in the Esperoct package.

Do not use the equipment without having received proper training from your doctor or nurse.

Wash your hands and make sure the area around you is clean.

When preparing and injecting the medicine directly into a vein, it is essentialto use a clean and germ-free technique (aseptic).A wrong technique may introduce germs capable of infecting the blood.

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

Do not use the equipment if it has fallen or been 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, the vial, the vial adapter, and 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 items until the reconstituted solution has been injected.

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 (located below the syringe)

1. Prepare the vial and syringe

•Prepare the number of Esperoct packages you need.

•Check the expiration date.

•Check the name, concentration, and colorof the package to ensure it contains the correct medicine.

•Wash your handsand dry them correctly with a clean towel or air.

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

•Take the vial and pre-filled syringe to room temperature.You can do this by holding both in your hands until you feel they are at the same temperature as your hands; see figureA.

Do not use any other system to heatthe vial and pre-filled syringe.

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

•Clean the rubber stopper with a sterile alcohol wipeand let it dry in the air for a few seconds before using it to ensure it is as free of germs as possible.

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

2. Place the vial adapter

•Remove the protective paperfrom 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 the protective cover with your fingers.

If you touch the spike of the vial adapter, you may transfer germs from your fingers.

•Place the vial on a flat and hard surface.

•Put the protective cover upside downand place the vial adapter firmly onto the vial.

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

•Compresslightlythe protective coverbetween your thumb and index finger as shown.

•Remove the protective coverfrom the vial adapter.

Do not remove the vial adapterwhen removing the protective cover.

3. Mount the plunger rod and syringe

•Hold the plunger rod by the wide end and remove it from the package.Do not touch the sides or the threads of the plunger rod.If you touch the sides or threads, you may transfer germs from your fingers.

•Immediately connect the plunger rod to the syringe by turning it to the right inside the plunger in the syringe until you feel resistance.

•Remove the syringe cap by bending it down until the perforation breaks.

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

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

•Tighten the syringe firmlyinto the vial adapter until you feel resistance.

4. Reconstitute the powder with the solvent

•Hold the syringe slightly tiltedwith the vial pointing downwards.

•Press the plunger rodto inject all the solvent into the vial.

•Keep the plunger rod pressed and gently removethe vial until the powder has dissolved.

Do not shake the vial, as this would produce foam.

•Check the reconstituted solution.It should be transparent and colorless, and there should be no visible particles.If you observe particles or a color change, do not use it.Use a new package instead.

It is recommended to use Esperoct immediately after reconstituting it.

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

•24hours when stored in the refrigerator (between 2°C and 8°C) or

•4hours at≤30°C or

•1hour between ?30°C and 40°C, only if the product has been stored before reconstitution above room temperature (?30°C to 40°C) not more than 3months.

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

•24hours when stored in the refrigerator (between 2°C and 8°C) or

•4hours (≤30°C)

Store the reconstituted medicine in the vial.

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

Store the reconstituted solution away from direct light.

If your dose requires more than one vial, repeat stepsAtoJwith more vials, vial adapters, and syringes until you reach the required dose.

•Keep the plunger rod pushed all the way in.

•Turn the syringe with the vialbottle downwards.

•Stop pushing the plunger rod and let it go backby itself while the reconstituted solution fills the syringe.

•Pull the plunger rod slightly downwardsto make the reconstituted solution flow into the syringe.

•If you do not need to use all the reconstituted medicine from the vial, use the syringe scale to extract the dose you need, as indicated by your doctor or nurse.

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

•While holding the vial bottle downwards,gently tap the syringeto make any bubbles rise to the top.

•Slowly push the plunger roduntil all the bubbles have been removed.

•Loosen the vial adapterfrom the vial.

Do not touch the tip of the syringe.If you touch the tip of the syringe, you may transfer germs from your fingers.

5. Inject the reconstituted solution

Now Esperoct is ready to be injected into a vein.

•Inject the reconstituted solution according to the instructions of your doctor or nurse.

•Inject it slowly over a period of 2minutes.

Do not mix Esperoct with other injections or intravenous medications.

Esperoct injection through connectors without needles for intravenous catheters (IV)

Warning:The syringe is made of glass and is designed to be compatible with standard Luer‑lock connectors. Some connectors without needles that have an internal spike are incompatible with the syringe. This incompatibility may prevent the administration of the medicine and cause damage to the connector without a needle.

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

•Use a clean and germ-free technique (aseptic). Follow the instructions for the proper use of your connector and DAVC with the guidance of your doctor or nurse.

•The injection into a DAVC may require using a sterile 10ml plastic syringe to extract the reconstituted solution. This should be done immediately after stepJ.

•If it is necessary to flush the DAVC line before or after the injection of Esperoct, use injectable solution of sodium chloride 9mg/ml (0.9%).

Disposal

•After injection, dispose of the unused Esperoct solution, the IV perfusion set, the vial with the vial adapter, and other residues safely following the instructions of your pharmacist.

Do not throw them away in household trash.

Do not disassemble the equipment before disposing of it.

Do not reuse the equipment.