ESPEROCT 500 IU Proszek i rozpuszczalnik do roztworu do wstrzykiwań

Treść ulotki

1. Esperoct 500 IU powder and solvent for injectable solution, 1,000 IU powder and solvent for injectable solution, 1,500 IU powder and solvent for injectable solution, 2,000 IU powder and solvent for injectable solution, 3,000 IU powder and solvent for injectable solution, 4,000 IU powder and solvent for injectable solution, 5,000 IU powder and solvent for injectable solution
   1. What is Esperoct and what is it used for
   2. What you need to know before using Esperoct
   3. How to use Esperoct
   4. Possible side effects
   5. How to store Esperoct
   6. Package contents and other information

Esperoct 500 IU powder and solvent for injectable solution, 1,000 IU powder and solvent for injectable solution, 1,500 IU powder and solvent for injectable solution, 2,000 IU powder and solvent for injectable solution, 3,000 IU powder and solvent for injectable solution, 4,000 IU powder and solvent for injectable solution, 5,000 IU powder and solvent for injectable solution

turoctocog alfa pegilated (human coagulation factor VIII pegilated (rDNA))
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start using the medicine as it contains
important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you notice any side effects, tell your doctor. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

• 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

1. What is Esperoct and what is it used for

What is Esperoct
Esperoct contains the active substance turoctocog alfa pegylated and is a long-acting recombinant coagulation factor VIII.
Factor VIII is a protein present in the blood that helps to prevent and stop bleeding.

What is Esperoct used for
Esperoct is used for the treatment or prevention of bleeding in patients of all age groups affected by hemophilia A (congenital factor VIII deficiency).
In people with hemophilia A, factor VIII is missing or does not function correctly. Esperoct
replaces this dysfunction or this deficiency of factor VIII and helps the blood to clot
at the point where bleeding occurs.

2. What you need to know before using Esperoct

Do not use Esperoct

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

Do not use Esperoct if any of the above conditions apply to you. If you are unsure, contact your
doctor before using the medicine.

Warnings and precautions
Previous use of medicines containing factor VIII
Tell your doctor if you have previously used medicines containing factor VIII, especially if you have developed
inhibitors (antibodies) to the medicine, as there may be a risk of this happening again.

Allergic reactions
There is a risk of developing a severe and sudden allergic reaction (e.g. anaphylactic reaction) to
Esperoct.
If you experience any of the early signs of an allergic reaction, stop the administration and contact your
doctor or emergency services immediately. The early signs of an allergic reaction may include
skin rash, hives, wheals, itching over large areas of the skin, redness and/or swelling of the
lips, tongue, face or hands, difficulty swallowing or breathing, wheezing, tightness in the chest, pale and cold skin, rapid heartbeat or dizziness, headache, nausea and vomiting.

Development of “factor VIII inhibitors” (antibodies)
Inhibitors (antibodies) may develop during treatment with medicines containing factor VIII

• These inhibitors, especially at high levels, interfere with the correct functioning of the treatment.
• Carefully monitor the development of these inhibitors.
• If bleeding is not controlled with Esperoct, inform your doctor immediately.
• Do not increase the total dose of Esperoct to control bleeding without first talking to your doctor.

Problems related to catheter use
If you use a catheter from which medicines can be injected into the blood (central venous access
system), infections or blood clots may develop at the catheter site.

Cardiovascular diseases
Tell your doctor or pharmacist if you have cardiovascular diseases or are at risk of a cardiovascular
disease.

Other medicines and Esperoct
Tell your doctor if you are taking, have recently taken or are planning to take any other medicines.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning to become pregnant, ask
your doctor for advice before taking this medicine.

Driving and using machines
Esperoct does not affect the ability to drive or use machines.

Decrease in factor VIII activity in previously untreated patients
A decrease in factor VIII activity may occur at the beginning of treatment. Contact your
doctor immediately if bleeding is not controlled with Esperoct.

Decrease in factor VIII activity in previously treated patients
A decrease in factor VIII activity may occur at the beginning of treatment. Contact your
doctor if bleeding is not controlled with the usual dose of Esperoct.

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

3. How to use Esperoct

Treatment with Esperoct must be initiated by a physician experienced in the care of individuals with
hemophilia A.
Always use this medicine exactly as your doctor has instructed. If you have any doubts about the use of
Esperoct, consult your doctor.

How to administer Esperoct
Esperoct is administered by an injection into a vein (intravenous), see “Instructions on how to use
Esperoct” for further information.

How much medicine to use
Your doctor will calculate the necessary dose for you. This will depend on your body weight and whether it is
being used to prevent or to treat a bleed.

Prevention of bleeding
For children (under 12 years of age), the recommended dose is 65 IU of Esperoct per kg of body weight twice
a week. Your doctor may choose a different dose or the frequency with which the injections must be
administered based on your needs.
In adults and adolescents (12 years and older), the recommended dose is 50 IU of Esperoct per kg of body
weight every 4 days. Your doctor may choose a different dose or the frequency with which the injections must
be administered based on your needs.

Treatment of bleeding
The dose of Esperoct is calculated based on body weight and the factor VIII levels that need to be
achieved. Optimal factor VIII levels will depend on the severity and location of the bleed. Contact your
doctor if the bleeding is not controlled with the usual dose of Esperoct.

Use in children and adolescents
For children (under 12 years of age), the recommended dose is 65 IU of Esperoct per kg of body weight twice
a week. Adolescents (12 years and older) can use the same dose as adults.

If you use more Esperoct than you should
If you use more Esperoct than you should, inform your doctor immediately.
Always use Esperoct exactly as your doctor has told you. You should consult your doctor if you are
unsure. 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
compensate for the missed dose. Proceed with the next injection as scheduled and continue as
recommended by your doctor. If you have any doubts, consult your doctor.

If you stop using Esperoct
Do not stop using Esperoct without first consulting your doctor.
If you stop treatment with Esperoct, you may no longer be protected from bleeding or ongoing bleeds may not
stop. For any questions about the use of this medicine, contact your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions (hypersensitivity)
Stop the injection immediately if severe and sudden allergic reactions (anaphylactic reactions) develop.
Contact your doctor or emergency room immediately if you experience any of the signs of an allergic
reaction such as:

• difficulty swallowing or breathing
• wheezing
• chest tightness
• redness and/or swelling of the lips, tongue, face or hands
• rash, hives, wheals or itching
• pale and cold skin, rapid heartbeat, or dizziness (low blood pressure)
• headache, feeling unwell (nausea) or feeling sick (vomiting).

Development of ‘factor VIII inhibitors’ (antibodies)
If you have previously been treated with factor VIII for more than 150 days, the development of inhibitors
(antibodies) is possible (may affect up to 1 in 100 people). If this happens, the medicine may not work
properly and you may experience persistent bleeding. If this situation occurs, 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 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 at the injection site
• tingling (pruritus)
• skin redness (erythema)
• rash.

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

• allergic reactions (hypersensitivity) These can become serious and can be life-threatening, see
  “Allergic reactions (hypersensitivity)” above for further information
• factor VIII inhibitors (antibodies) in patients previously treated with factor VIII.

Other possible side effects (frequency not known)
Decreased factor VIII activity in the absence of factor VIII inhibitors.
At the beginning of treatment, a temporary response from the immune system may occur, which
may make the medicine less effective.

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 through the reporting system detailed in Annex V. By reporting side effects, you can help
provide more information on the safety of this medicine.

5. How to store 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 packaging, vial and
pre-filled syringe label after ‘EXP’. The expiry date refers to the last day of the
month indicated.

Before reconstitution(before the powder is mixed with the solvent):
Store in a refrigerator (2 °C - 8 °C). Esperoct can be kept

• at room temperature (≤ 30 °C) for a single period of time up to 1 year, within the product’s expiry period or
• above room temperature (> 30 °C up to 40 °C) for a single period of time not exceeding 3 months within the product’s expiry period.

When you start to store Esperoct outside the refrigerator, record the date and storage temperature in the space provided on the packaging.
After taking the medicine out of the refrigerator for storage, it is not necessary to return it
to the refrigerator. Do not freeze. Store in the original packaging to protect the
medicine from light.

After reconstitution(after the powder has been mixed with the solvent – 500 IU, 1 000 IU,
1 500 IU, 2 000 IU, 3 000 IU):
Once Esperoct has been reconstituted, it must be used immediately. If you cannot use
the reconstituted solution immediately, it must be used within

• 24 hours if stored in a refrigerator (2 °C - 8 °C) or
• 4 hours if stored at ≤ 30 °C or
• 1 hour between > 30 °C and 40 °C, only if the product has been stored above room temperature (> 30 °C up to 40 °C) before reconstitution for no more than 3 months.

After reconstitution(after the powder has been mixed with the solvent – 4 000 IU, 5 000 IU)
The physical and chemical stability in use of the product has been demonstrated for:

• 24 hours if stored in a refrigerator (2 °C - 8 °C) or
• 4 hours at ≤ 30 °C.

The powder in the vial appears from white to off-white. 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
particles or colour changes.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. These measures will help to
protect the environment.

6. Package contents and other information

What Esperoct contains

• The active substance is turoctocog alfa pegylated (human coagulation factor VIII (rDNA) pegylated). Each vial of Esperoct nominally contains 500, 1,000, 1,500, 2,000, 3,000, 4,000 or 5,000 IU of turoctocog alfa pegylated.
• The other excipients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
• The ingredients in the solvent are an injectable solution of sodium chloride 9 mg/mL (0.9%) and water for injections. See section 2 “Esperoct contains sodium”.

After reconstitution with the provided solvent (sodium chloride 9 mg/mL (0.9%) injectable solution), the prepared injectable solution contains 125, 250, 375, 500, 750, 1,000 or 1,250 IU of turoctocog alfa pegylated per mL, respectively (based on the turoctocog alfa pegylated dosage, e.g. 500, 1,000, 1,500, 2,000, 3,000, 4,000 or 5,000 IU).

Description of Esperoct’s appearance and package contents
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 white or off-white powder, one prefilled syringe with 4 mL of clear and colourless solvent, one plunger and one vial adapter.

Marketing Authorisation Holder:
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark

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

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 provided in the syringe. The solvent is a 9 mg/mL (0.9%) sodium chloride injectable solution. The reconstituted medicine must be injected into a vein (intravenous injection). The contents of this pack are designed to reconstitute and inject Esperoct.
You will also need:

• an infusion kit (butterfly needle with tubing)
• sterile alcohol swabs
• cotton gauze and plasters. These devices are not included in the Esperoct pack.

Do not use the contents without adequate training from your doctor or nurse.
Always wash your hands and ensure the surrounding area is clean.
When preparing and injecting a medicine directly into a vein, it is important to use an aseptic technique and be germ-free.Incorrect technique can introduce germs that can infect the blood.

Do not open the contents until you are ready to use it.
Do not use the contents if it has been dropped or is damaged.Use a new pack instead.

Do not use the contents if it is expired.Use a new pack instead. The expiry date is printed on the outer packaging, on the vial, on the vial adapter and on the prefilled syringe.

Do not use the contents if you suspect it has been contaminated.Use a new pack instead.

Do not discard any of the items until the reconstituted solution has been injected.
The contents are for single use only.
Contents
The pack contains:

• 1 vial with Esperoct powder
• 1 vial adapter
• 1 prefilled syringe with solvent
• 1 plunger (located under the syringe)

Overview

Plunger

Thread

End

1. Prepare the vial and the syringe Remove the number of Esperoct packages needed. Check the expiration date. Check the name, dosage and color of the package to make sure it contains the correct product. Wash and dry your hands thoroughly with a clean towel or in the air. Remove the vial, vial adapter and prefilled syringe from the package. Leave the plunger intact inside the package. Bring the vial and prefilled syringe to room temperature. You can do this by holding them in your hands until you feel they are warm like your hands, see figure A. Do not use other ways to warm the vial and the prefilled syringe.	A o c a m r a F l e d
n Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial. Clean the rubber stopper of the vial with a sterile swab moistened with alcohol and let it air dry for a few seconds before use to make sure it is germ-free. Do not touch the rubber stopper with your fingers as it may transfer germs.	B
a 2. Attach the vial adapter Remove the protective seal from the vial adapter. If the protective seal is not hermetically sealed or is broken, do not use the adapter. Do not remove the vial adapter from the protective cap with your fingers. If you touch the tip of the vial adapter, germs from your fingers may be transferred.	C

Place the vial on a flat and stable surface. Rotate the protective cap and attach the adapter to the vial. Once attached, do not remove the adapter from the vial.	D o c a
Lightly press the protective cap with your thumb and index finger, as shown. Remove the protective cap from the adapter. Do not lift the adapter from the vial when removing the protective cap.	m E r a F l
3. Attach the plunger and the syringe Grasp the plunger by the end and remove it from the package. Do not touch the sides or the thread of the plunger. If you touch the sides or the thread, germs from your fingers may be transferred. Immediately attach the plunger to the syringe by screwing it clockwise onto the piston inside the prefilled syringe, until you feel resistance.	e F d
l a Remove the syringe cap by bending it down to break it off. Do not touch the tip of the syringe under the syringe cap. If you touch the tip of the syringe, germs from your fingers may be transferred. If the syringe cap is loose or missing, do not use the prefilled syringe.	G
z n Carefully screw the prefilled syringe onto the adapter until you feel resistance.	H

4. Reconstitute the powder with the solvent Hold the prefilled syringe slightly tilted with the vial facing down. Press the plunger to inject all the solvent into the vial.	I o c a
Keep the plunger pressed down and gently rotate the vial until the powder dissolves. Do not shake the vial, as foam may form. Check the reconstituted solution. It should be clear and colorless and no particles should be visible. If you notice particles or color changes, do not use it. Use a new package instead.	m J r a F l e d
a It is recommended to use Esperoct immediately after reconstitution. 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 must be used: within 24 hours if stored in the refrigerator (2 °C - 8 °C) or within 4 hours if stored at ≤ 30 °C or within 1 hour between > 30 °C and 40 °C, only if the product has been stored above room temperature (> 30 °C to 40 °C) before reconstitution for no more than 3 months. If you cannot use the reconstituted Esperoct solution immediately, (applies to 4,000 IU, 5,000 IU) it must be used within: 24 hours if stored in the refrigerator (2 °C - 8 °C) or 4 hours if stored at ≤ 30 °C Store the reconstituted medicine in the vial. Do not freeze the reconstituted solution or store it in the syringe. Keep the reconstituted solution protected from direct light. If your dose requires more than one vial, repeat steps A to J with the other vials, adapters and prefilled syringes, until the required dose is reached.

Keep the plunger pressed down. Rotate the syringe with the vial facing down. Stop pressing the plunger and let it return on its own as the reconstituted solution fills the syringe. Gently pull back the plunger to aspirate the reconstituted solution into the syringe. If you do not need to use all of the reconstituted medicine in the vial, use the scale on the syringe to release the required dose, as determined by the doctor or nurse. If, at this point, there is air in the syringe, inject the air into the vial. Holding the vial upside down, gently tap the syringe to allow any air bubbles to rise to the top. Slowly push the plunger until all air bubbles have disappeared.	K o c a m r a F l e d a
i Unscrew the adapter with the vial. Do not touch the tip of the syringe. If you touch the tip of the syringe, germs from your fingers may be transferred.	L
a 5. Inject the reconstituted solution Esperoct is now ready to be injected intravenously. Inject the reconstituted solution according to the instructions of the doctor or nurse. Inject slowly over approximately 2 minutes. Do not mix Esperoct with another intravenous solution or with other medicines. Inject Esperoct through needleless connectors for central venous catheters. Caution: The prefilled syringe is made of glass and is designed to be compatible with standard luer-lock connectors. Some needleless connectors with an internal end are not compatible with prefilled syringes. This incompatibility may prevent the administration of the medicine and damage the needleless connector. Inject the solution through a central venous access device (CVC) or a subcutaneous port:

Use an aseptic technique and in a germ-free manner. Follow the instructions for proper use of the connector and central venous catheter (CVC) as suggested by the doctor or nurse. Injection into a CVC may require the use of a 10 mL sterile plastic syringe to withdraw the reconstituted solution. This step must be done after step J. If the CVC tubing needs to be flushed before and after injection with Esperoct, use a 9 mg/mL (0.9%) sodium chloride injectable solution.
Disposal After the injection, discard all unused Esperoct solution, the syringe with the infusion set, the vial with the adapter and other waste materials as directed by the pharmacist. Do not dispose of with household waste.	m M r a F
l e Do not disassemble the instruments before disposal. Do not reuse the material.