Label: information for the user

ALTUVOCT 250 UI powder and solvent for injectable solution

ALTUVOCT 500 UI powder and solvent for injectable solution

ALTUVOCT 750 UI powder and solvent for injectable solution

ALTUVOCT 1 000 UI powder and solvent for injectable solution

ALTUVOCT 2 000 UI powder and solvent for injectable solution

ALTUVOCT 3 000 UI powder and solvent for injectable solution

ALTUVOCT 4 000 UI powder and solvent for injectable solution

efanesoctocog alfa (human recombinant coagulation factor VIII)

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to use this medicine, 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 medicine 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 do not appear in this label. See section 4.

ALTUVOCT contains the active ingredient efanesoctocog alfa, a factor VIII replacement protein.

ALTUVOCT is used to treat and prevent bleeding episodes in patients with hemophilia A (a hereditary bleeding disorder caused by a deficiency of factor VIII) and can be used in patients of all age groups.

Factor VIII is a naturally occurring protein in the body that is necessary for blood to form clots and stop bleeding. In patients with hemophilia A, factor VIII is either absent or does not function properly.

ALTUVOCT replaces this deficient or absent factor VIII. ALTUVOCT increases factor VIII concentrations in the blood, thereby helping blood to form clots at the site of bleeding, which temporarily corrects the tendency to experience bleeding episodes.

Do not use ALTUVOCT

• if you are allergic to efanesoctocog 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 ALTUVOCT.

• There is a rare possibility that you may suffer an anaphylactic reaction (a severe and sudden allergic reaction) to ALTUVOCT. Among the signs of allergic reactions are generalised 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.

• Consult your doctor if you think you are not controlling your bleeding or your child's bleeding with the dose you receive, as there may be several reasons for this. In some people who use this medication, antibodies against factor VIII (also known as factor VIII inhibitors) may develop. The formation of factor VIII inhibitors is a known complication that may occur during treatment with all factor VIII medications. These inhibitors, especially at high levels, prevent the treatment from working properly; you or your child will be closely monitored for the development of these inhibitors.

Cardiovascular events

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

Complications associated with the catheter

If you need a central venous access device (CVAD), the risk of complications related to the CVAD, including local infections, presence of bacteria in the blood and thrombosis at the catheter insertion site, should be taken into account.

Other medications and ALTUVOCT

Inform your doctor 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 or plan to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

The influence of ALTUVOCT on the ability to drive and operate machinery is negligible or insignificant.

ALTUVOCT treatment will be initiated by an experienced doctor in the care of patients with hemophilia A. ALTUVOCT is administered through an injection into a vein.

After receiving the necessary training in the correct injection technique, patients or caregivers can administer ALTUVOCT at home. Your doctor will calculate your dose (in international units [IU]). This will depend on your weight and whether it is for prevention or treatment of bleeding episodes.

Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

Keep a record

Each time you use ALTUVOCT, note the date, the name of the medication, and the batch number.

Prevention of bleeding episodes

The usual dose of ALTUVOCT is 50 international units (IU) per kilogram of body weight. The injection is administered once a week.

Treatment of bleeding episodes

The dose of ALTUVOCT is 50 international units (IU) per kilogram of body weight. The dose and frequency may be adjusted according to the severity and location of the bleeding episode.

Use in children and adolescents

ALTUVOCT can be used in children of all ages; the dosage recommendation is the same as in adults.

How to administer ALTUVOCT

ALTUVOCT is administered through an injection into a vein. See «Instructions on how to use ALTUVOCT» for more information.

If you use more ALTUVOCT than you should

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

If you forgot to use ALTUVOCT

Do not inject a double dose to compensate for the missed doses. Inject 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 ALTUVOCT

If you interrupt treatment with ALTUVOCT, you may no longer be protected against bleeding episodes or a bleeding episode that already exists may not stop. Do not interrupt treatment with ALTUVOCT without consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If an anaphylactic reaction occurs, the injection should be stopped immediately and you should contact your doctor immediately.

The symptoms of an anaphylactic reaction are, among others, the following:

Risk of inhibitor formation

In children who have not received previous treatment with factor VIII medications, the formation of inhibitor antibodies (see section 2) is very common (can affect more than 1 in 10 patients); however, in patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is rare (can affect up to 1 in 100 patients). If you or your child experience the formation of inhibitor antibodies, the medicine may not work properly and you or your child may experience persistent bleeding. If this occurs, you should contact your doctor immediately.

The following side effects may appear with this medicine.

Very common side effects (can affect more than 1 in 10 people)

• Headache
• Arthralgia (joint pain)

Common side effects (can affect up to 1 in 10 people)

• Pain in the limbs (arms, hands, legs, or feet)
• Back pain
• Eczema (itching, redness, or dryness of the skin)
• Skin rash
• Urticaria (itching rash)
• Fever
• Vomiting

Rare side effects (can affect up to 1 in 100 people)

• Reactions at the injection site (including hematomas and inflammation)

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 leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about 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 vial after «CAD/EXP». The expiration date is the last day of the month indicated.

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

Do not freeze.

Store the vial in the outer packaging to protect it from light.

Before reconstitution, the ALTUVOCT powder can be stored at room temperature (≤ 30 °C) for a single period not exceeding 6 months. The date of removal from the refrigerator must be noted on the box. After storage at room temperature, the medication must not be reintroduced into the refrigerator.

The medication must not be used after the expiration date printed on the vial or six months after removing the box from the refrigerator, whichever occurs first.

Once the ALTUVOCT powder has been dissolved in the solvent provided in the preloaded syringe, it must be used immediately. Do not refrigerate the prepared solution.

After reconstitution, the solution must be transparent and between colorless and slightly opalescent. Do not use this medication if it appears turbid or contains visible particles.

Medicines must not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of ALTUVOCT

• The active principle is efanesoctocog alfa (human recombinant factor VIII coagulation).

Each vial of ALTUVOCT contains nominally 250, 500, 750, 1,000, 2,000, 3,000 or 4,000 IU of efanesoctocog alfa.

• The other components are sucrose, calcium chloride dihydrate, histidine, arginine hydrochloride and polisorbate 80.

Aspect of the product and contents of the package

ALTUVOCT is presented in the form of a powder and a solvent for injectable solution. The powder is a loose or compact powder of white to off-white color. The solvent supplied for the preparation of the injectable solution is a transparent and colorless solution. After preparation, the injectable solution is transparent and between colorless and slightly opalescent.

Each package of ALTUVOCT contains 1 vial of powder, 3 ml of solvent in a pre-loaded syringe, 1 plunger rod, 1 vial adapter, and 1 infusion set.

Holder of the marketing authorization and responsible for manufacturing

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Swedish Orphan Biovitrum AB (publ)

Norra Stationsgatan 93

113 64 Stockholm

Sweden

Last review date of this leaflet:

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

Turn the leaflet over to see instructions for preparation and administration of the medicine.

Instructions for use of ALTUVOCT

READ THESE INSTRUCTIONS CAREFULLY BEFORE USING ALTUVOCT

ALTUVOCT is administered by intravenous injection after dissolving the injectable powder with the solvent supplied in the pre-loaded syringe.

If your dose requires more than one vial, you will receive several packages and, ideally, a large syringe.

Your healthcare professional should teach you how to prepare and inject ALTUVOCT correctly before you use it for the first time. Ask your healthcare professional if you have any doubts.

Important information

Check that the name and dose of the medicine are correct and that you know the frequency of administration of ALTUVOCT.

Do not use the medicine if it has expired, has been opened or appears to be damaged.

ALTUVOCT should not be mixed with other injectable solutions.

Ideally, ALTUVOCT should be stored in the refrigerator. Allow the vial and the solvent syringe to reach room temperature before use. Do not use external heat.

Check that none of the elements are damaged before use; do not use them if they appear to be damaged.

All elements are valid for single use.

Wash your hands and clean a flat surface before preparing the kit. Place the syringe safely on a flat surface when not handling it.

Guide to the components (included in the box)

ALTUVOCT is reconstituted by dissolving the injectable powder (A) in the solvent supplied in the pre-loaded syringe (B). Subsequently, the ALTUVOCT solution should be administered using the infusion set (E).

Additional components (not included in the box)

Ensure that you have alcohol wipes (F).

You may have been supplied a large syringe (G) by your pharmacist to extract the solution from several vials into a single syringe. If you have NOT been supplied a large syringe, follow steps 6 to 8 to administer the solution from each syringe.

Reconstitution

Administration