ELOCTA 4000 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

ELOCTA 250 UI powder and solvent for solution for injection

ELOCTA 500 UI powder and solvent for solution for injection

ELOCTA 750 UI powder and solvent for solution for injection

ELOCTA 1000 UI powder and solvent for solution for injection

ELOCTA 1500 UI powder and solvent for solution for injection

ELOCTA 2000 UI powder and solvent for solution for injection

ELOCTA 3000 UI powder and solvent for solution for injection

ELOCTA 4000 UI 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 further 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 signs of illness 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 pack

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

1. What is ELOCTA and what is it used for

ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII, Fc fusion protein. Factor VIII is a protein that is naturally produced by the body and is necessary for blood to clot and stop bleeding. ELOCTA is a medicine used to treat and prevent bleeding in patients of all ages with hemophilia A (a bleeding disorder caused by a lack of factor VIII).

ELOCTA is prepared using recombinant technology without the addition of any human or animal component in the manufacturing process.

How ELOCTA works

In patients with hemophilia A, factor VIII is missing or does not work properly. ELOCTA is used to replace the missing or deficient 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 you use ELOCTA

Do not use ELOCTA:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using ELOCTA.

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

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

Cardiovascular events

If you have heart disease or are at risk of heart disease, be careful when using factor VIII medicines and talk to your doctor.

Catheter-related complications

If you need a central venous access device (CVAD), consider the risk of CVAD-related complications, including local infections, bacteria in the blood, and thrombosis at the catheter insertion site.

Documentation

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

Other medicines and ELOCTA

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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; this 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.

3. How to use ELOCTA

Treatment with ELOCTA will be started by a doctor who is experienced in the care of patients with hemophilia. Follow exactly the administration instructions for this medicine given by your doctor (see section Instructions for preparation and administration). If you are unsure, talk to your doctor, pharmacist, or nurse.

ELOCTA is given by injection into a vein. Your doctor will calculate your dose of ELOCTA (in International Units or "IU"), depending on your individual needs for factor VIII replacement treatment and whether it is used for prevention or treatment of bleeding. Talk to your doctor if you think you are not getting control of your bleeding with the dose you are getting.

How often you need an injection will depend on how well ELOCTA is working for you. Your doctor will do the relevant laboratory tests to make sure you have adequate levels of factor VIII in your blood.

Treatment of bleeding

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

Prevention of bleeding

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

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 needed.

If you use more ELOCTA than you should

Tell your doctor as soon as possible. Follow exactly the administration instructions for ELOCTA given by your doctor. If you are unsure, talk to your doctor, pharmacist, or nurse.

If you forget to use ELOCTA

Do not take a double dose to make up for forgotten doses. Take your dose as soon as you remember and then continue with your normal dosing schedule. If you are not sure what to do, talk to your doctor or pharmacist.

If you stop using ELOCTA

Do not stop using ELOCTA without talking to your doctor. If you stop using ELOCTA, you may no longer be protected against bleeding or an existing 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 and sudden allergic reactions (anaphylactic reaction) occur, the injection should be stopped immediately. Contact your doctor immediately if you get any of the following symptoms of allergic reactions: swelling of the face, rash, generalized itching, hives, feeling of chest tightness, difficulty breathing, and low blood pressure.

In previously untreated children with factor VIII medicines (see section 2) inhibitors 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 infrequent (less than 1 in 100 patients). If this happens, the medicines may stop working properly and you may have persistent bleeding. In this case, 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, taste disturbances, slow heart rate, high blood pressure, flushing, vascular pain after injection, cough, lower abdominal pain, skin rash, papular rash, catheter-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 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 via the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton and on the label of the vial after "EXP". The expiry date refers to the last day of the month shown.

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 from light.

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

Once ELOCTA has been prepared, it should be used immediately. If it is not possible to use the prepared ELOCTA solution immediately, it should be used within 6 hours. Do not refrigerate the prepared solution. Protect the prepared solution from direct sunlight.

The prepared solution should be clear to slightly opalescent and colorless. Do not use this medicine if you notice it 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 no longer required. This will help protect the environment.

6. Container Contents and Additional Information

ELOCTA Composition

• The active ingredient 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, L-histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid, and water for injectable preparations. See section 2 if you are on a low-sodium diet.

Product Appearance and Container Contents

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 solution for injection is a clear and colorless solution. After preparation, the solution for injection is clear to slightly opalescent and colorless.

Each ELOCTA container contains 1 vial of powder, 3 mL of solvent in a prefilled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 band-aids, and 1 gauze.

Marketing Authorization Holder and Manufacturer

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm,

Sweden

Date of Last Revision of this Leaflet: 01/2021

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

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

Preparation and Administration Instructions

ELOCTA is administered by intravenous (IV) injection after dissolving the injectable powder with the solvent supplied in the prefilled syringe. The ELOCTA container contains:

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

Wash your hands before opening the container.

Preparation:

Administration (Intravenous Injection):

ELOCTA should be administered using the infusion set (E) provided in the container.