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 must 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 are not listed in this label. See section 4.

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.

Do not use ELOCTA:

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.

Cardiovascular events

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

Complications related to the catheter

If you need a central venous access device (DAVC), be aware of the risk of complications related to the DAVC, 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

No effects on the ability to drive or operate machines 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.

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 through an 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, 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 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.

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 pressure, 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 occur 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, feeling of cold, feeling 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.

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 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 ELOCTA has been prepared, it must be used immediately. If the prepared ELOCTA solution cannot be used 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 must be transparent to slightly opalescent and colorless. Do not use this medication if it is observed to be cloudy or contains visible particles.

Properly dispose of any unused solution. Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition of ELOCTA

• The active ingredient is efmoroctocog alfa (recombinant 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 a 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 solutions or infusion fluids.

Wash your hands before opening the package.

Preparation:

Administration (intravenous injection):

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