Label: information for the user

ALPROLIX 250UI powder and solvent for injectable solution

ALPROLIX 500UI powder and solvent for injectable solution

ALPROLIX 1000UI powder and solvent for injectable solution

ALPROLIX 2000UI powder and solvent for injectable solution

ALPROLIX 3000UI powder and solvent for injectable solution

eftrenonacog alfa factorIX coagulation factor recombinant, fusion proteinFc

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others 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 section4.

ALPROLIX contains the active ingredient eftrenonacog alfa, a recombinant factorIX coagulation factor, fusion proteinFc. The factorIX is a protein naturally produced by the body and is necessary for blood to form clots and stop bleeding.

ALPROLIX is a medication used for the treatment and prevention of bleeding in patients of all age groups with hemophiliaB (a hereditary bleeding disorder caused by a deficiency of factorIX).

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

How ALPROLIX works

In patients with hemophiliaB, the factorIX is either absent or does not function properly. This medication is used to replace the absent or deficient factorIX. ALPROLIX increases the concentrations of factorIX in the blood and temporarily corrects the tendency to experience bleeding. The fusion proteinFc of this medication prolongs the duration of the medication's action.

Do not use ALPROLIX

• If you are allergic to eftrenonacog alfa or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use ALPROLIX.

• There is a small chance that you may have an anaphylactic reaction (a severe and sudden allergic reaction) to ALPROLIX. Symptoms of allergic reactions include generalized itching, hives, feeling of chest tightness, difficulty breathing, and low blood pressure. If any of these symptoms appear, stop the injection immediately and contact your doctor. Due to the risk of allergic reactions with factor IX, your first administrations of ALPROLIX should be performed under medical supervision in a place where adequate medical assistance can be provided in case of allergic reactions.

• Consult your doctor if you think you are not controlling bleeding with the dose you receive, as there may be several reasons for this. For example, the formation of antibodies (also known as inhibitors) against factorIX is a known complication that can occur during the treatment of hemophiliaB. Antibodies prevent the treatment from working properly. Your doctor will check if this is the case. Do not increase the total dose of ALPROLIX to control bleeding without talking to your doctor first.

Patients with a factorIX inhibitor may have a higher risk of anaphylaxis during future treatments with factorIX. Therefore, if you experience allergic reactions as described above, you should have a test to check for the presence of an inhibitor.

FactorIX medications may increase the risk of unwanted blood clots in your body, especially if you have risk factors for developing blood clots. Symptoms of a possible unwanted blood clot may include: pain and/or tenderness along a vein, unexpected swelling of an arm or leg, or sudden or difficulty breathing.

Cardiovascular disorders

If you have been told that you have a heart condition or are at risk of developing one, be especially careful when using factor IX 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, the presence of bacteria in the blood, and blood clots at the catheter insertion site.

Documentation

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

Other medications and ALPROLIX

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

The influence of ALPROLIX on the ability to drive and operate machines is negligible.

ALPROLIX contains sodium

This medication contains less than 1mmol of sodium (23mg) per vial; it is essentially “sodium-free”. In case of treatment with multiple vials, the total sodium content should be taken into account.

The treatment with ALPROLIX 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 section7). In case of doubt, consult your doctor, pharmacist, or nurse again.

ALPROLIX is administered by injection into a vein. You or another person can administer it after receiving the necessary training. Your doctor will decide on the dose (in International Units or “UI”) that you will receive. The dose will depend on your individual needs for factorIX 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 the medication is showing with you. Your doctor will perform relevant laboratory tests to ensure that you have adequate factorIX concentrations in your blood.

Bleeding episode treatment

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

Bleeding episode prevention

If you are using ALPROLIX to prevent bleeding episodes, your doctor will calculate the dose.

The usual dose of ALPROLIX is 50UI per kg of body weight, administered once a week, or 100UI per kg of body weight, administered once every 10days. Your doctor may adjust the dose or interval. In some cases, especially in younger patients, it may be necessary to use shorter dosing intervals or higher doses.

Use in children and adolescents

ALPROLIX can be used in children and adolescents of all ages. In children under 12years, higher doses or more frequent injections may be necessary, and the usual dose is 50 to 60UI per kg of body weight, administered once every 7days.

If you take more ALPROLIX than you should

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

If you forget to use ALPROLIX

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, pharmacist, or nurse.

If you interrupt treatment with ALPROLIX

Do not interrupt treatment with ALPROLIX without consulting your doctor. If you interrupt treatment with ALPROLIX, 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 medicines, this medicine can cause side effects, although not everyone 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, feeling of tightness in the chest, difficulty breathing, stinging and pinching at the injection site, chills, hot flashes, headache, general feeling of discomfort, nausea, agitation, rapid heart rate, and low blood pressure.

In children who have not received prior treatment with medications containing factor IX, it is common for inhibitors to form (in up to 1 in 10 patients) (see section 2). If this occurs, the medicine may not work properly and your child may experience persistent bleeding. If this occurs, contact your doctor immediately.

The following side effects may appear with this medicine.

Frequent side effects (may affect up to 1 in 10 people):headache, numbness or tingling in the mouth, pain in the side with blood in the urine (urinary obstruction) and redness at the injection site.

Children who have not received prior treatment with medications containing factor IX: factor IX inhibitors, hypersensitivity.

Rare side effects (may affect up to 1 in 100 people):dizziness, taste alterations, bad breath, feeling of fatigue, pain at the injection site, rapid heart rate, blood in the urine (hematuria), kidney pain (renal colic), low blood pressure, and decreased appetite.

Side effects of unknown frequency (frequency cannot be estimated from available data):severe and sudden allergic reaction and potentially fatal allergic reaction (anaphylactic shock).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side 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 side effects, you can contribute to providing more information on the safety of this medicine.

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, ALPROLIX can be stored at room temperature (up to 30°C) for a single period not exceeding 6months. Note on the box the date when ALPROLIX 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 ALPROLIX, you must use it immediately. If you cannot use the prepared solution immediately, you must use it within a maximum of 6hours if it has been stored at room temperature. Do not refrigerate the solution after preparing it. Protect the 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.

This medication is for single use only.

Dispose of any unused solution remainder properly. Medications should not be thrown down the drain 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.

Composition of ALPROLIX

Solution:

• The active ingredient is eftrenonacog alfa (recombinant factor IX, fusion protein Fc). Each vial of ALPROLIX contains nominally 250, 500, 1,000, 2,000, or 3,000 IU of eftrenonacog alfa.
• The other components are sucrose, L-histidine, mannitol, polisorbate 20, sodium hydroxide, and hydrochloric acid. See section 2 if you are on a low-sodium diet.

Vehicle:

5 ml of sodium chloride and water for injection

Appearance of the product and contents of the pack

ALPROLIX is presented as a powder and vehicle for injectable solution. The powder is a white to off-white powder. The vehicle supplied for the preparation of the solution is a transparent and colourless solution. After preparation, the solution is transparent to slightly opalescent and colourless.

Each pack of ALPROLIX contains 1 vial of powder, 5 ml of vehicle in a pre-loaded syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol wipes, 2 band-aids, and 1 gas.

Marketing authorisation holder and manufacturer

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Telephone: +46 8 697 20 00

Last update of this leaflet: 01/2024

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicinal products.

Turn the leaflet over to consult section 7. Instructions for preparation and administration

7.Instructions for preparation and administration

The following procedure describes the preparation and administration of ALPROLIX.

ALPROLIX is administered by intravenous injection (IV) after dissolving the powder with the vehicle supplied in the pre-loaded syringe. The pack of ALPROLIX contains:

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

Wash your hands before opening the pack.

Preparation:

Administration (intravenous injection):

ALPROLIX should be administered using the infusion set (E) supplied in the pack.