Elocta 1000 IU powder and solvent for solution for injection

Spain
Brand name Elocta 1000 IU powder and solvent for solution for injection
Form powder and solvent for solution for injection
Active substance / Dosage
EFMOROCTOCOG ALFA · 133,3 µg
Prescription type Hospital Use Only
ATC code
B02B B02BD B02BD02
Registration number 1151046004
Manufacturer Swedish Orphan Biovitrum Ab (Publ)
Elocta 1000 IU powder and solvent for solution for injection powder and solvent for solution for injection

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ELOCTA 250IU powder and solvent for solution for injection

ELOCTA 500IU powder and solvent for solution for injection

ELOCTA 750IU powder and solvent for solution for injection

ELOCTA 1000IU powder and solvent for solution for injection

ELOCTA 1500IU powder and solvent for solution for injection

ELOCTA 2000IU powder and solvent for solution for injection

ELOCTA 3000IU powder and solvent for solution for injection

ELOCTA 4000IU powder and solvent for solution for injection

efmoroctocog alfa (recombinant coagulation factor VIII)

Read all of this leaflet carefully before you start using this medicine because 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. It may harm them, even if their symptoms are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the 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 ELOCTA is and what it is used for

ELOCTA contains the active substance efmoroctocog alfa, a recombinant factor VIII, Fc fusion protein. Factor VIII is a protein naturally produced by the body and is necessary for blood to form clots and stop bleeding.

ELOCTA is a medicine used for the treatment and prevention of bleeding in patients of all age groups with haemophilia A (an inherited bleeding disorder caused by factor VIII deficiency).

ELOCTA is produced using recombinant technology without the addition of any components of human or animal origin during the manufacturing process.

How ELOCTA works

In patients with haemophilia A, factor VIII is missing or does not function properly. ELOCTA is used to replace the missing or deficient factor VIII. ELOCTA increases factor VIII concentrations 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 starting to use ELOCTA.

  • There is a small possibility that you may experience an anaphylactic reaction (a severe and sudden allergic reaction) to ELOCTA. Signs of allergic reactions include generalized itching, hives, tightness in the chest, difficulty breathing, and low blood pressure. If any of these symptoms occur, stop the injection immediately and contact your doctor.

  • The development of inhibitors (antibodies) is a known complication that may occur during treatment with all factor VIII-containing medicines. These inhibitors, especially in large amounts, can prevent the treatment from working properly, so you and your child will be closely monitored for the development of such inhibitors. If your bleeding or your child's bleeding is not being controlled with ELOCTA, consult your doctor immediately.

Cardiovascular events

If you have heart disease or are at risk of developing it, take special care when using factor VIII-containing medicines and consult your doctor.

Catheter-related complications

If a central venous access device (CVAD) is required, the risk of CVAD-related complications should be considered, including local infections, presence of bacteria in the blood, and thrombosis at the catheter insertion site.

Documentation

We strongly recommend that each time ELOCTA is administered, the product name and batch number are recorded.

Other medicines and ELOCTA

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

Pregnancy and breastfeeding

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

Driving and using machines

No effects on the ability to drive or use machines have been observed.

ELOCTA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; that is, essentially “sodium-free”.

However, depending on your body weight and dose, you may receive more than one vial, which should be taken into account if you are on a low-sodium diet.

ELOCTA contains Polysorbate

This medicine contains 0.4 mg of polysorbate 20 in each vial. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use ELOCTA

Treatment with ELOCTA will be initiated by a physician experienced in the care of patients with haemophilia. Follow exactly the administration instructions for this medicine as indicated by your physician (see Preparation and Administration Instructions). If in doubt, consult your physician, pharmacist, or nurse again.

ELOCTA is administered by intravenous injection. Your physician will calculate the dose of ELOCTA (in International Units or “IU”) based on your individual factor VIII replacement therapy needs and whether it is being used for prevention or treatment of bleeding episodes. Consult your physician if you think that your current dose is not adequately controlling your bleeding episodes.

How frequently you will need an injection depends on the level of effectiveness ELOCTA is showing for you. Your physician will perform appropriate laboratory tests to ensure that you have adequate factor VIII concentrations in your blood.

Treatment of bleeding episodes

The ELOCTA dose is calculated based on your body weight and the desired factor VIII concentrations. The target factor VIII concentrations depend on the severity and location of the bleeding episode.

Prevention of bleeding episodes

The usual dose of ELOCTA is 50 IU per kg of body weight, administered every 3 to 5 days. Your physician may adjust the dose within a range of 25 to 65 IU per kg of body weight. In some cases, especially in younger patients, shorter dosing intervals or higher doses may be required.

Use in children and adolescents

ELOCTA can be used in children and adolescents of all ages. In children under 12 years of age, higher doses or more frequent injections may be necessary.

If you use more ELOCTA than you should

Inform your physician as soon as possible. Always follow exactly the administration instructions for ELOCTA as indicated by your physician. If in doubt, consult your physician, pharmacist, or nurse again.

If you forget to use ELOCTA

Do not take a double dose to make up for missed doses. Take your dose as soon as you remember, then resume your normal dosing schedule. If you are unsure what to do, consult your physician or pharmacist.

If you stop using ELOCTA

Do not stop treatment with ELOCTA without consulting your physician. If you stop treatment with ELOCTA, you may no longer be protected against bleeding episodes, or an existing bleed may not stop.

If you have any further questions about the use of this medicine, ask your physician, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If serious and sudden allergic reactions (anaphylactic reaction) occur, the injection must be stopped immediately. You should contact your doctor immediately if you experience any of the following symptoms of allergic reactions: facial swelling, rash, widespread itching, hives, tightness in the chest, difficulty breathing, stinging and tingling at the injection site, chills, hot flushes, headache, low blood pressure, general feeling of discomfort, nausea, restlessness, rapid heartbeat, dizziness or loss of consciousness.

In children who have not previously been treated with factor VIII-containing medicines, inhibitor antibodies may develop very commonly (more than 1 in 10 patients); however, in patients who have previously received treatment with factor VIII (more than 150 days of treatment), the risk is uncommon (less than 1 in 100 patients). If this occurs, the medicines may no longer work properly and you may experience persistent bleeding. In such a case, contact your doctor immediately.

The following adverse effects may occur with this medicine.

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

Headache, dizziness, taste disturbances, slow heartbeat, high blood pressure, hot flushes, vascular pain after injection, cough, lower abdominal pain, skin rash, papular rash, device-related thrombosis, joint swelling, muscle pain, back pain, joint pain, general malaise, chest pain, feeling of cold, feeling of warmth and low blood pressure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 ELOCTA

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

Do not use this medicine after the expiry date stated on the carton and on the label of the vial after “EXP”. The expiry date refers to the last day of the month indicated. Do not use this medicine if it has been stored at room temperature for more than 6 months.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze.

Keep in the original packaging to protect from light.

Alternatively, ELOCTA may be stored at room temperature (up to 30 °C) for a single period not exceeding 6 months. Record on the carton the date when ELOCTA was removed from the refrigerator and placed at room temperature. After storage at room temperature, the medicine must not be returned to the refrigerator.

Once ELOCTA has been prepared, it should be used immediately. If you cannot use the prepared solution of ELOCTA immediately, it must be used within a maximum of 6 hours. Do not refrigerate the prepared solution. Protect the prepared solution from direct sunlight.

The prepared solution should be transparent to slightly opalescent and colourless. Do not use this medicine if you notice that the solution is cloudy or contains visible particles.

Dispose of any unused solution properly. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ELOCTA

  • The active substance is efmoroctocog alfa (recombinant coagulation factor VIII, Fc fusion protein). Each vial of ELOCTA nominally contains 250, 500, 750, 1,000, 1,500, 2,000, 3,000 or 4,000 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. See section 2 if you are on a low-sodium diet.

Nature of the medicinal product and contents of the pack

ELOCTA is presented as a powder and solvent for solution for injection. The powder is a white to off-white powder or cake. The solvent supplied for the preparation of the injectable solution is a clear, colourless solution. After reconstitution, the solution for injection is clear to slightly opalescent and colourless.

Each ELOCTA pack contains 1 vial of powder, 3 ml of solvent in a pre-filled syringe, 1 syringe plunger, 1 vial adapter, 1 infusion set, 2 alcohol wipes, 2 adhesive bandages and 1 gauze pad.

Marketing Authorisation Holder

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Telephone: +46 8 697 20 00

Manufacturer

Swedish Orphan Biovitrum AB (publ)

Norra Stationsgatan 93

SE-113 64 Stockholm

Sweden

Date of the most recent revision of this leaflet

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

Turn over the leaflet to read the instructions for preparation and administration.

Instructions for preparation and administration

ELOCTA is administered by intravenous (IV) injection after dissolving the injectable powder with the solvent supplied in the pre-filled syringe. The ELOCTA pack contains:

Technical drawing of medical components with labels: vial, syringe, plunger, adapter, infusion kit, wipes, bandages, and gauze

ELOCTA must not be mixed with other injectable solutions or infusion solutions.

Wash your hands before opening the pack.

Preparation:

  1. Check the name and dose of the medicine on the packaging to ensure it contains the correct medication. Check the expiration date on the ELOCTA carton. Do not use the medicine if it has expired.
  1. If ELOCTA has been stored in the refrigerator, allow the ELOCTA vial (A) and the solvent syringe (B) to reach room temperature before use. Do not use external heat.
  1. Place the vial on a clean, flat surface. Remove the

plastic closure cap from the ELOCTA vial.

Two hands hold a glass vial while one hand rotates the cap to the left, indicated by a black curved arrow

  1. Clean the top of the vial with one of the alcohol wipes (F) provided in the package and allow it to air dry.

Do not touch the top of the vial or allow it to come into contact with anything after cleaning.

A hand lifts the cap off a small glass vial containing a white opaque liquid

  1. Peel off the paper protective cap from the clear plastic vial adapter (D). Do not remove the adapter from its protective closure cap. Do not touch the inside of the vial adapter housing.
  1. Place the vial on a flat surface. Hold the vial adapter in its protective closure cap and place it directly onto the top of the vial. Press down firmly until the adapter snaps onto the top of the vial, with the adapter's piercing pin penetrating the vial stopper.

A hand presses a cap onto the top of a glass vial while a box with a cross indicates the action

  1. Attach the plunger rod (C) to the solvent syringe by inserting the tip of the plunger rod into the syringe plunger opening. Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger.

A hand holds a syringe while a

  1. Remove the white plastic, tamper-evident closure cap from the solvent syringe by bending the breakable ring until it breaks. Set the closure cap aside, placing it with the top facing down on a flat surface. Do not touch the inside of the closure cap or the tip of the syringe.

A hand holds a syringe while the

  1. Remove the protective closure cap from the adapter by lifting it off and discard it.

A hand lifts a protective cap upward

  1. Connect the solvent syringe to the vial adapter by inserting the syringe tip into the adapter opening. Push firmly and turn the syringe clockwise until it is securely attached.

A hand holds a syringe and rotates it downward with a curved arrow indicating attachment to the vial below

  1. Slowly push the plunger rod all the way down to inject the entire solvent into the ELOCTA vial.

Two hands operate a syringe with a plunger being pushed down to draw liquid from a medical vial below

  1. With the syringe still attached to the adapter and the plunger rod fully depressed, gently swirl the vial until the powder is completely dissolved.

Do not shake.

A hand holds a syringe to rotate the top onto a medication vial, indicated by two black circular arrows

  1. The final solution should be inspected visually before administration. The solution should be clear to slightly opalescent and colorless. Do not use the solution if it is cloudy or contains visible particles.
  1. While ensuring the syringe plunger rod remains fully depressed, invert the vial. Slowly pull back on the plunger rod to transfer all the solution into the syringe through the vial adapter.

A hand holds a syringe vertically while the

  1. Disconnect the syringe from the vial adapter by gently pulling the syringe while turning it counterclockwise.

A hand rotates downward

Note: If more than one ELOCTA vial is used per injection, each vial must be prepared separately according to the previous instructions (steps 1 to 13), and the solvent syringe should be removed, leaving the vial adapter in place. A single larger Luer-Lock syringe may be used to withdraw the prepared solution from each vial.

  1. Dispose of the vial and adapter.

Note: If the solution is not to be used immediately, the closure cap of the syringe should be carefully replaced over the syringe tip. Do not touch the syringe tip or the inside of the closure cap.

After preparation, ELOCTA may be stored at room temperature for up to 6 hours prior to administration. After this time, the prepared ELOCTA solution must be discarded. Protect it from direct sunlight.

Administration (intravenous injection):

ELOCTA must be administered using the infusion set (E) supplied in the package.

  1. Open the infusion set container and remove the closure cap from the end of the tube. Attach the syringe containing the prepared ELOCTA solution to the end of the infusion set tubing by turning it clockwise.

A hand holds a syringe with a needle and the

  1. If necessary, apply a tourniquet and prepare the injection site by thoroughly cleaning the skin with the other alcohol wipe provided in the package.

Two schematic drawings show hands applying a patch to the upper arm for transdermal administration

  1. Remove all air from the infusion set tubing by slowly pushing the plunger down until the liquid reaches the needle of the infusion set. Do not push the solution through the needle. Remove the transparent plastic protective cap from the needle.
  1. Insert the needle of the infusion set into a vein, as instructed by your doctor or nurse, and remove the tourniquet. If desired, you may use one of the adhesive bandages (G) provided in the package to secure the plastic wings of the needle in place at the injection site. The prepared product should be administered intravenously over several minutes. Your doctor may adjust the recommended infusion rate to make it more comfortable for you.
  1. After the infusion is complete and the needle has been removed, fold back the needle safety shield and secure it over the needle.

Two hands separate the two components of a medical device with a black curved arrow indicating an outward opening movement

  1. Safely dispose of the used needle, any unused solution, the syringe, and the empty vial in an appropriate medical waste container, as these materials may cause harm to others if not properly discarded. Do not reuse any equipment.