ALTUVOCT 4,000 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

ALTUVOCT 250 IU powder and solvent for solution for injection

ALTUVOCT 500 IU powder and solvent for solution for injection

ALTUVOCT 750 IU powder and solvent for solution for injection

ALTUVOCT 1,000 IU powder and solvent for solution for injection

ALTUVOCT 2,000 IU powder and solvent for solution for injection

ALTUVOCT 3,000 IU powder and solvent for solution for injection

ALTUVOCT 4,000 IU powder and solvent for solution for injection

efanesoctocog alfa (recombinant human coagulation factor VIII)

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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

1. What is ALTUVOCT and what is it used for

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

ALTUVOCT is used to treat and prevent bleeding episodes in patients with haemophilia 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 protein that is naturally present in the body and is necessary for blood to form clots and stop bleeding. In patients with haemophilia A, factor VIII is missing or does not work properly.

ALTUVOCT replaces this missing or defective factor VIII. ALTUVOCT increases the factor VIII levels in the blood, helping the blood to form clots at the site of bleeding, which temporarily corrects the tendency to bleed.

2. What you need to know before you use ALTUVOCT

Do not use ALTUVOCT

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with ALTUVOCT.

• There is a rare possibility that you may experience an anaphylactic reaction (a severe and sudden allergic reaction) to ALTUVOCT. Signs of allergic reactions include generalised itching, rash, feeling of chest tightness, difficulty breathing, and low blood pressure. If any of these symptoms occur, stop the injection immediately and contact your doctor.

• Consult your doctor if you think you are not getting control over your bleeding or your child's bleeding with the dose you are receiving, as there may be several reasons for this. In some people using this medicine, antibodies against factor VIII (also known as factor VIII inhibitors) may develop. The formation of factor VIII inhibitors is a known complication that can occur during treatment with all factor VIII medicines. 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 heart disease or are at risk of heart disease, be careful when using factor VIII medicines and consult 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.

Other medicines and ALTUVOCT

Tell your doctor 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 plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

ALTUVOCT has no or negligible influence on the ability to drive and use machines.

3. How to use ALTUVOCT

Treatment with ALTUVOCT will be started by a doctor experienced in the care of patients with haemophilia A. ALTUVOCT is administered by 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 used for prevention or treatment of bleeding.

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor, pharmacist, or nurse again.

Keep a record

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

Prevention of bleeding

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

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

Use in children and adolescents

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

How to administer ALTUVOCT

ALTUVOCT is administered by 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 your doctor's instructions for administering ALTUVOCT exactly. If you are unsure, consult your doctor, pharmacist, or nurse again.

If you forget to use ALTUVOCT

Do not inject a double dose to make up for forgotten doses. Inject your dose as soon as you remember and then resume your normal dosing schedule. If you are unsure, consult your doctor, pharmacist, or nurse.

If you stop treatment with ALTUVOCT

If you stop treatment with ALTUVOCT, you may no longer be protected against bleeding or an existing bleed may not stop. Do not stop treatment with ALTUVOCT without consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Symptoms of an anaphylactic reaction are, among others:

Risk of inhibitor formation

In children who have not received prior treatment with factor VIII medicines, the formation of inhibitory antibodies (see section 2) is very common (may affect 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 uncommon (may affect up to 1 in 100 patients). If you or your child develop inhibitory antibodies, the medicine may stop working properly, and you or your child may experience persistent bleeding. If this happens, contact your doctor immediately.

The following side effects may occur with this medicine.

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

• headache
• arthralgia (joint pain)

Common side effects (may 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)
• rash
• urticaria (itchy rash)
• fever
• vomiting

Uncommon side effects (may affect up to 1 in 100 people)

• reactions at the injection site (including bruising and inflammation)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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 ALTUVOCT

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 vial after "EXP". The expiry date refers to the last day of the month shown.

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

Do not freeze.

Keep the vial in the outer carton in order to protect 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 should be noted on the carton. After storage at room temperature, the medicine should not be returned to the refrigerator.

The medicine should not be used after the expiry date printed on the vial or 6 months after removal from the refrigerator, whichever is the earlier.

Once the ALTUVOCT powder has been dissolved in the solvent provided in the pre-filled syringe, it should be used immediately. Do not refrigerate the prepared solution.

After reconstitution, the solution should be clear and colourless to slightly opalescent. Do not use this medicine if you notice it is cloudy or contains visible particles.

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

ALTUVOCT Composition

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

Each ALTUVOCT vial nominally contains 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 polysorbate 80.

Product Appearance and Container Contents

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

Each ALTUVOCT container contains 1 vial of powder, 3 mL of solvent in a prefilled syringe, 1 plunger rod, 1 vial adapter, and 1 infusion set.

Marketing Authorization Holder and Manufacturer

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Swedish Orphan Biovitrum AB (publ)

Norra Stationsgatan 93

113 64 Stockholm

Sweden

Date of Last Revision of this Leaflet:

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

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

Instructions on How to Use 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 prefilled syringe.

If your dose requires more than one vial, you will receive several containers 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 questions.

Important Information

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

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

ALTUVOCT must not be mixed with other injectable solutions.

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

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

All components are for single use only.

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

Guide to Components (Included in the Box)

ALTUVOCT is reconstituted by dissolving the injectable powder (A) in the solvent supplied in the prefilled syringe (B). The ALTUVOCT solution is then administered using the infusion set (E).

Additional Components (Not Included in the Box)

Make sure you have alcohol swabs (F).

Your pharmacist may have provided a large syringe (G) separately to withdraw the solution from multiple vials into a single syringe. If you have NOT been provided with a large syringe, follow steps 6 to 8 to administer the solution from each syringe.

Reconstitution

Administration