ELOCTA 250 IU Порошок и раствор для инъекционного раствора

Содержание инструкции

1. ELOCTA 250 IU powder and solvent for injectable solution, 500 IU powder and solvent for injectable solution, 750 IU powder and solvent for injectable solution, 1000 IU powder and solvent for injectable solution, 1500 IU powder and solvent for injectable solution
   1. What is ELOCTA and what is it used for
   2. What you need to know before using ELOCTA
   3. How to use ELOCTA
   4. Possible side effects
   5. How to store ELOCTA
   6. Contents of the pack and other information

ELOCTA 250 IU powder and solvent for injectable solution, 500 IU powder and solvent for injectable solution, 750 IU powder and solvent for injectable solution, 1000 IU powder and solvent for injectable solution, 1500 IU powder and solvent for injectable solution

ELOCTA 2000 IU powder and solvent for injectable solution
ELOCTA 3000 IU powder and solvent for injectable solution
ELOCTA 4000 IU powder and solvent for injectable solution
efmoroctocog alfa (recombinant coagulation factor VIII)

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What ELOCTA is and what it is used for
• 2. What you need to know before you use ELOCTA
• 3. How to use ELOCTA
• 4. Possible side effects
• 5. How to store ELOCTA
• 6. Contents of the pack and other information

1. What is ELOCTA and what is it used for

ELOCTA contains the active substance efmoroctocog alfa, a fusion protein between recombinant coagulation factor VIII and Fc. Factor VIII is a natural protein produced by the body and is essential for the formation of blood clots and to stop bleeding.
ELOCTA is a medicine used for the treatment and prevention of bleeding in patients of all ages with hemophilia A (an inherited bleeding disorder due to a deficiency of factor VIII).
ELOCTA is produced using recombinant technology, without the addition of any human or animal-derived components in the manufacturing process.

How ELOCTA works
In patients with hemophilia A, factor VIII is absent or does not function as it should. ELOCTA serves to replace the missing or insufficiently present factor VIII. ELOCTA increases the levels of factor VIII in the blood and temporarily corrects the tendency to bleed.

2. What you need to know before using ELOCTA

Do not use ELOCTA:

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ELOCTA.

• There is a possibility, albeit low, that you may develop an anaphylactic reaction (a severe and sudden allergic reaction) to ELOCTA. The signs of an allergic reaction may include widespread itching, hives, a feeling of tightness in the chest, difficulty breathing and low blood pressure. If any of these symptoms occur, stop the infusion immediately and see a doctor.
• The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII-based medicines. Inhibitors, especially at high levels, prevent the treatment from working properly and you or your child will be carefully monitored to check for the development of these inhibitors. If ELOCTA does not control bleeding in you or your child, tell your doctor immediately.

Cardiovascular events
If you suffer from heart disease or are at risk of heart disease, pay particular attention when using
factor VIII-based medicines and see your doctor.
Catheter-related complications
If a central venous access device (CVAD) is necessary, the risk of
CVAD-related complications should be considered, including local infections, bloodstream infections and thrombosis
at the catheter site.
Documentation
It is strongly recommended to record the name and lot number of the product each time you receive
ELOCTA.

Other medicines and ELOCTA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No effects on the ability to drive and use machines have been observed.

ELOCTA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.
However, depending on your body weight and the dose you need to take, you may receive more than one
vial. Take this into account if you are on a low-sodium diet.

3. How to use ELOCTA

Treatment with ELOCTA will be initiated by a doctor experienced in the care of patients with hemophilia. Use
this medicine following the doctor's instructions exactly at all times (see Instructions for
preparation and administration). If you have any doubts, consult your doctor, pharmacist or nurse.
ELOCTA is administered via infusion into a vein. The doctor will calculate the dose of ELOCTA (in
International Units or “IU”) based on the individual’s need for factor VIII replacement therapy and
depending on whether it is used for prevention or for the treatment of bleeding. Contact your doctor
if you believe that bleeding is not sufficiently controlled with the dose you are receiving.
How often you will need to receive an infusion depends on how ELOCTA works in your specific case. The
doctor will perform the necessary laboratory tests to check that the levels of factor VIII in the blood
are adequate.

Treatment of bleeding
The dose of ELOCTA is calculated based on body weight and the levels of factor VIII that you wish to
achieve. The desired levels of factor VIII depend on the severity and location of the bleeding.

Prevention of bleeding
The usual dose of ELOCTA is 50 IU per kg of body weight, to be administered every 3-5 days. The
dose may be modified by the doctor within a range of 25 to 65 IU per kg of body weight. In
some cases, particularly in young patients, shorter administration intervals or higher doses may be necessary.

Use in children and adolescents
ELOCTA can be used in children and adolescents of any age. In children under the age of
12 years, higher doses or more frequent infusions may be necessary.

If you use more ELOCTA than you should
Inform your doctor as soon as possible. Use ELOCTA following the doctor's instructions exactly at all times. If you
have any doubts, consult your doctor, pharmacist or nurse.

If you forget to use ELOCTA
Do not take a double dose to make up for a missed dose. Take the dose as soon as you remember and then resume your usual dosing schedule. If you have any doubts, consult your doctor or
pharmacist.

If you stop using ELOCTA
Do not stop treatment with ELOCTA without consulting your doctor. If you stop treatment with
ELOCTA, you may no longer have any protection against bleeding or an ongoing bleed may not stop.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If severe allergic reactions (anaphylactic reactions) occur suddenly, the infusion must be
stopped immediately. You should seek medical attention immediately if you experience any of the
following symptoms of an allergic reaction: swelling of the face, skin rash, widespread itching,
hives, a feeling of tightness in the chest, difficulty breathing, burning and stinging pain at the site of
infusion, chills, hot flushes, headache, low blood pressure, a general feeling of being unwell,
nausea, restlessness and rapid heartbeat, dizziness or loss of consciousness.
In children not previously treated with factor VIII-based medicines, the formation of inhibitor
antibodies (see section 2) may be very common (more than 1 in 10 patients); however, in patients who
have received previous treatment with factor VIII (more than 150 days of treatment) the risk is
uncommon (less than 1 in 100 patients). If this happens, the medicine may stop working
correctly and you may experience prolonged bleeding. If this happens, you should contact your doctor
immediately.
The following side effects may occur with this medicine:

Uncommon side effects (may affect up to 1 in 100 people)
Headache, dizziness, altered sense of taste, slowed heartbeat, high blood pressure, hot flushes, vascular
pain after infusion, cough, lower abdominal pain, skin rash, rash with papules, catheter-associated
thrombosis, joint swelling, muscle pain, back pain, joint pain, general malaise, chest pain, feeling of
cold, feeling of heat and low blood pressure.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system listed in Annex V. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store ELOCTA

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 package and on the label of the
vial after “Expiry/EXP”. The expiry date refers to the last day of that month. Do not use
this medicine if it has been stored at room temperature for more than 6 months.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store in the original package to protect the medicine from light.
Alternatively, ELOCTA can be stored at room temperature (up to 30 °C) for a single
period not exceeding 6 months. Note on the package the date on which ELOCTA was removed from the
refrigerator and stored at room temperature. After being stored at room temperature, the
product must not be returned to the refrigerator.
After preparation, ELOCTA must be used immediately. If you cannot use the ELOCTA
solution immediately after preparation, you must use it within 6 hours. Do not store the prepared solution in
the refrigerator. Protect the prepared solution from direct sunlight.
The prepared solution should be from clear to slightly opalescent and colourless. Do not use this
medicine if you notice that it is cloudy or contains particles.
Correctly dispose of any unused solution. Do not throw any medicine into the drain or into
household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What ELOCTA contains

• The active substance is efmoroctocog alfa (recombinant coagulation factor VIII fusion protein with Fc). Each vial of ELOCTA nominally contains 250, 500, 750, 1000, 1500, 2000, 3000 or 4000 IU of efmoroctocog alfa.
• The other components are sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid and water for injections. If you are on a low-sodium diet, see section 2.

Description of ELOCTA and contents of the pack
ELOCTA is supplied as a powder and solvent for injection. The powder is presented as
powder or a mass of white to off-white colour. The solvent supplied for the preparation of the
solution for injection is a clear and colourless solution. After preparation, the solution for injection is
from clear to slightly opalescent and colourless.
Each pack of ELOCTA contains 1 vial of powder, 3 mL of solvent in a pre-filled syringe, 1
plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters
and 1 gauze.

Marketing Authorisation Holder
Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm
Sweden
Tel.: +46 8 697 20 00

Manufacturer
Swedish Orphan Biovitrum AB (publ)
Norra Stationsgatan 93
SE-113 64 Stockholm
Sweden
More detailed information on this medicine is available on the European Medicines Agency’s website, http://www.ema.europa.eu/ .

Instructions for preparation and administration
ELOCTA must be administered by intravenous (i.v.) infusion after dissolving the powder for
injectable preparation in the solvent supplied in the pre-filled syringe. The ELOCTA pack contains:
ELOCTA must not be mixed with other injectable or infusion solutions.
Wash your hands before opening the pack.

Preparation

• 1. Check the name and dosage stated on the pack and make sure that it contains the correct medicine. Check the expiry date on the ELOCTA carton. Do not use a medicine after the expiry date.
• 2. If ELOCTA has been stored in a refrigerator, allow the ELOCTA vial (A) and the syringe with the solvent (B) to reach room temperature before use. Do not use external heat sources.
• 3. Place the vial on a clean, flat surface. Remove the plastic tear-off cap from the ELOCTA vial. A) 1 Vial of powder B) 3 mL of solvent in pre-filled syringe C) 1 Plunger rod D) 1 Vial adapter E) 1 Infusion set F) 2 Alcohol swabs G) 2 Plasters H) 1 Gauze

• 4. Clean the top of the vial with one of the alcohol swabs (F) included in the pack and allow it to air dry. Do not touch the top of the vial once it has been cleaned and do not allow it to come into contact with other objects.

• 5. Open the protective paper cover of the plastic transparent vial adapter (D). Do not remove the adapter from its protective cap. Do not touch the inside of the vial adapter pack.
• 6. Place the vial on a flat surface. Hold the vial adapter with its protective cap and position it perpendicularly above the vial. Press firmly downwards until the adapter clicks into place on top of the vial, with the tip piercing the vial stopper.

• 7. To connect the plunger rod (C) to the syringe containing the solvent, insert the end of the plunger rod into the opening in the syringe plunger. Rotate the plunger rod firmly clockwise until it is securely fitted into the syringe plunger.

• 8. Break the white plastic tamper-evident cap on the syringe containing the solvent by bending the cap where perforated until it breaks off. Set the cap aside on a flat surface with the top facing downwards. Do not touch the inside of the cap or the tip of the syringe.

• 9. Remove the protective cap from the adapter and discard it.

• 10. To connect the syringe containing the solvent to the vial adapter, insert the tip of the syringe into the opening in the adapter. Press firmly and rotate the syringe clockwise until it is securely fixed.

• 11. Slowly press down on the plunger rod to inject all the solvent into the ELOCTA vial.

• 12. With the syringe still connected to the adapter and continuing to press on the plunger rod, gently rotate the vial to dissolve the powder. Do not shake.

• 13. The final solution must be visually inspected before administration. The solution must be from clear to slightly opalescent and colourless. Do not use the solution if it is cloudy or contains visible particles.

• 14. Invert the vial while continuing to press the plunger rod of the syringe all the way down. Slowly pull back on the plunger rod to draw all the solution into the syringe through the vial adapter.

• 15. Detach the syringe from the vial adapter by gently pulling on the vial and rotating it counter-clockwise.

Note: if you are using more than one vial of ELOCTA for infusion, each vial must be prepared
separately according to the instructions (points 1-13) and the syringe containing the solvent must be
removed, leaving the vial adapter in place. To draw the contents from the individual
vials after preparation, a single large luer lock syringe can be used.

• 16. Discard the vial and adapter.

Note: if the solution is not used immediately, the syringe must be carefully re-sealed with
its cap. Do not touch the tip of the syringe or the inside of the cap.
After preparation, ELOCTA can be stored at room temperature before
administration for a maximum of 6 hours. After this time has elapsed from preparation,
ELOCTA must be discarded. Protect from direct sunlight.

Administration (intravenous infusion)
ELOCTA must be administered with the infusion set (E) supplied with the pack.

• 1. Open the packaging of the infusion set and remove the cap at the end of the tube. Connect the syringe containing the prepared ELOCTA solution to the end of the infusion set tube by rotating clockwise.

• 2. If necessary, apply a tourniquet and clean the infusion site by thoroughly rubbing the skin with the other alcohol swab included in the pack.

• 3. Remove any air that may be present in the infusion set tube by slowly pressing down on the plunger rod until the liquid reaches the needle of the infusion set. Do not push the solution into the needle. Remove the plastic protective cap from the needle.
• 4. Insert the needle of the infusion set into a vein, according to the instructions received from your doctor or nurse, and remove the tourniquet. If preferred, one of the plasters (G) supplied with the pack can be used to secure the plastic wings of the needle at the infusion site. The prepared product must be injected intravenously over several minutes. For more comfortable treatment, the doctor may adjust the recommended infusion rate.
• 5. After completing the infusion and removing the needle, cover the needle with the protective cap, closing it until it clicks.

• 6. Dispose of the used needle safely, along with any residual solution, the syringe and the empty vial in a suitable container for medical waste, as these materials can cause harm to others if they are not disposed of correctly. Do not reuse used material.