Ficha técnica de Elocta 3000 ui polvo y disolvente para solucion inyectable – Espanha

Como usar Elocta 3000 ui polvo y disolvente para solucion inyectable

Introduction

Label: information for the user

ELOCTA 250 UI powder and diluent for injectable solution

ELOCTA 500 UI powder and diluent for injectable solution

ELOCTA 750 UI powder and diluent for injectable solution

ELOCTA 1000 UI powder and diluent for injectable solution

ELOCTA 1500 UI powder and diluent for injectable solution

ELOCTA 2000 UI powder and diluent for injectable solution

ELOCTA 3000 UI powder and diluent for injectable solution

ELOCTA 4000 UI powder and diluent for injectable solution

efmoroctocog alfa (recombinant coagulation factor VIII)

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

Keep this label, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section 4.

1. What is ELOCTA and how is it used

ELOCTA contains the active ingredient efmoroctocog alfa, a recombinant coagulation 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 medication used for the treatment and prevention of bleeding in patients of all age groups with hemophilia A (a hereditary bleeding disorder caused by a deficiency of factor VIII).

ELOCTA is prepared 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 either absent or does not function properly. ELOCTA is used to replace the absent or deficient factor VIII. ELOCTA increases factor VIII concentrations in the blood and temporarily corrects the tendency to experience bleeding.

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

Do not use ELOCTA:

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

Warnings and precautions

Consult 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. Among the signs of allergic reactions are generalized itching, hives, sensation of chest tightness, difficulty breathing, and low blood pressure. If any of these symptoms appear, stop the injection immediately and contact your doctor.

Factor VIII inhibitor formation is a known complication that may occur during treatment with all factor VIII products. These inhibitors, especially in large quantities, prevent the treatment from working properly, so you and your child will be closely monitored for the development of these inhibitors. If your bleeding or your child's bleeding is not being controlled with ELOCTA, consult your doctor immediately.

Cardiovascular events

If you have a heart condition or are at risk of developing one, be especially careful when using factor VIII medications and consult your doctor.

Catheter-related complications

If you need a central venous access device (CVAD), be aware of the risk of CVAD-related complications, 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 noted.

Other medications and ELOCTA

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

Driving and operating machinery

No effects on the ability to drive or operate machinery have been observed.

ELOCTA contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free."

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

3. How to Use ELOCTA

The treatment with ELOCTA will be initiated by a doctor with experience in caring for patients with hemophilia. Follow exactly the administration instructions for this medication as indicated by your doctor (see Preparation and Administration Instructions section). In case of doubt, consult your doctor, pharmacist, or nurse again.

ELOCTA is administered by injection into a vein. Your doctor will calculate your ELOCTA dose (in International Units or "UI"), depending on your individual needs for factor VIII substitution treatment and whether it is used for prevention or treatment of bleeding episodes. Consult your doctor if you think you are not controlling bleeding episodes with the dose you receive.

The frequency of injections will depend on the degree of efficacy that ELOCTA is showing with you. Your doctor will perform relevant laboratory tests to ensure that you have adequate factor VIII concentrations in your blood.

Bleeding Treatment

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.

Bleeding Prevention

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

Use in Children and Adolescents

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

If You Use More ELOCTA Than You Should

Inform your doctor as soon as possible. Follow exactly the administration instructions for ELOCTA as indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

If You Forget to Use ELOCTA

Do not take a double dose to compensate for the missed doses. Take your dose as soon as you remember and then resume your normal dosing schedule. If you are unsure of what to do, consult your doctor or pharmacist.

If You Interrupt Treatment with ELOCTA

Do not interrupt treatment with ELOCTA without consulting your doctor. If you interrupt treatment with ELOCTA, you may no longer be protected against bleeding episodes or a pre-existing bleeding episode may not stop.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not all people will experience them.

If severe and sudden allergic reactions (anaphylactic reaction) occur, the injection should be stopped immediately. Contact your doctor immediately if you experience any of the following symptoms of allergic reactions: facial swelling, rash, generalized itching, hives, sensation of chest tightness, difficulty breathing, stinging and pinching at the injection site, chills, hot flashes, headache, low blood pressure, general feeling of discomfort, nausea, agitation, and rapid heart rate, sensation of dizziness or loss of consciousness.

In children without prior treatment with factor VIII-containing medications, the production of inhibitor antibodies (see section 2) may occur very frequently (more than 1 in 10 patients); however, in patients who have received prior treatment with factor VIII (more than 150 days of treatment), the risk is rare (less than 1 in 100 patients). If this happens, the medication may not work properly and you may experience persistent bleeding. In that case, contact your doctor immediately.

The following adverse effects may appear with this medication.

Adverse effects that are infrequent (may affect up to 1 in 100 people)

Headache, dizziness, taste alterations, slow heart rate, high blood pressure, hot flashes, vascular pain after injection, cough, lower abdominal pain, skin rash, papular rash, device-related thrombosis, joint swelling, muscle pain, back pain, joint pain, general discomfort, chest pain, sensation of cold, sensation of heat, and low blood pressure.

Reporting Adverse Effects

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

5. Storage of ELOCTA

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

Do not use this medication after the expiration date that appears on the box and on the vial label after “CAD/EXP”. The expiration date is the last day of the month indicated. Do not use this medication if it has been stored at room temperature for more than 6 months.

Store in the refrigerator (between 2 °C - 8 °C).

Do not freeze.

Store in the original packaging to protect it 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 box the date when ELOCTA was removed from the refrigerator and left at room temperature. After storage at room temperature, the medication should not be returned to the refrigerator.

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

The prepared solution must be transparent to slightly opalescent and colorless. Do not use this medication if you observe that it is cloudy or contains visible particles.

Properly dispose of any unused solution. Medications should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of ELOCTA

The active ingredient is efmoroctocog alfa (recombinant coagulation factor VIII, Fc fusion protein). Each vial of ELOCTA contains nominally 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, L-histidine, dihydrate calcium chloride, polisorbate 20, sodium hydroxide, hydrochloric acid, and water for injection. See Section 2 if you are on a low-sodium diet.

Appearance of the product and contents of the package

ELOCTA is presented as a powder and diluent for injectable solution. The powder is a white to off-white powder. The diluent supplied for the preparation of the injectable solution is a transparent and colorless solution. After preparation, the injection solution is transparent to slightly opalescent and colorless.

Each package of ELOCTA contains 1 vial of powder, 3 mL of diluent in a pre-loaded syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol wipes, 2 band-aids, and 1 gauze.

Marketing authorization holder and manufacturer responsible

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm,

Sweden

Last review date of this leaflet: 01/2021

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

Turn the leaflet over to consult the preparation and administration instructions

Preparation and administration instructions

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

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

Wash your hands before opening the package.

Preparation:

Check the name and dose of the medicine on the package, to ensure that it contains the correct medicine. Check the expiration date on the ELOCTA package. Do not use the medicine if it is expired.

If ELOCTA has been stored in the refrigerator, let the vial of ELOCTA (A) and the diluent syringe (B) reach room temperature before use. Do not use external heat.

Place the vial on a clean and flat surface. Remove the plastic closure cap from the ELOCTA vial.

Clean the top of the vial with one of the alcohol wipes (F) supplied in the package and let it dry in the air. Do not touch the top of the vial or allow it to come into contact with anything once you have cleaned it.

Remove the paper protective cap from the transparent plastic vial adapter (D). Do not remove the adapter from its protective closure capsule. Do not touch the inside of the adapter vial container.

Hold the adapter vial in its protective closure capsule and place it directly on top of the vial. Press firmly down until the adapter fits onto the top of the vial, with the adapter's perforator piercing the vial's stopper.

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

Remove the protective closure capsule of the diluent syringe by bending it until it breaks. Leave the closure capsule aside, with the top facing down on a flat surface. Do not touch the inside of the closure capsule or the tip of the syringe.

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

Connect the diluent syringe to the adapter vial by inserting the tip of the syringe into the opening of the adapter. Push firmly and turn the syringe clockwise until it is securely connected.

Slowly push the plunger rod down to inject all the diluent into the ELOCTA vial.

With the syringe still connected to the adapter and the plunger rod pressed down, gently move the vial in a circular motion until the powder has dissolved.

Do not shake.

The final solution should be visually inspected before administration. The solution should be transparent to slightly opalescent and colorless. Do not use the solution if it is cloudy or contains visible particles.

Ensuring that the plunger rod of the syringe remains completely pressed down, invert the vial. Slowly pull the plunger rod to transfer all the solution into the syringe through the adapter vial.

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

Nota: If you use more than one vial of ELOCTA per injection, each vial should be prepared separately according to the previous instructions (steps 1-13) and the diluent syringe should be removed, leaving the adapter vial in place. A single larger Luer lock syringe can be used to extract the prepared contents from each vial.

Discard the vial and adapter.

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

After preparation, ELOCTA can be stored at room temperature for a maximum of 6 hours before administration. Once this time has elapsed, the prepared ELOCTA solution should be discarded. Protect it from direct sunlight.

Administration (intravenous injection):

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

Open the infusion set package and remove the closure cap from the end of the tube. Connect the syringe with the prepared ELOCTA solution to the end of the tube of the infusion set by turning clockwise.

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

Remove any air from the tube of the infusion set by slowly pushing the plunger rod down until the liquid has reached the needle of the infusion set. Do not push the solution through the needle. Remove the transparent plastic protective cap from the needle.

Insert the needle of the infusion set into a vein, as instructed by your doctor or nurse, and remove the tourniquet. If desired, you can use one of the band-aids (G) supplied in the package to hold the plastic wings of the needle in place at the injection site. The prepared product should be injected intravenously over several minutes. Your doctor may modify the recommended infusion rate to make it more comfortable for you.

Once the injection is complete and the needle is removed, the needle protector should be retracted and fitted over the needle.

Dispose of the used needle, any unused solution, the syringe, and the empty vial safely in an appropriate medical waste container, as these materials can cause harm to others if not disposed of properly. Do not reuse the equipment.