ALTUVOCT 2 000 IU powder and solvent for solution for injection

• 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.

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

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

Talk to your doctor, pharmacist, or nurse before using ALTUVOCT.

• There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ALTUVOCT. Signs of allergic reactions may include generalised itching, hives, tightness of the chest, difficulty in breathing, and low blood pressure. If any of these symptoms occur, stop the injection immediately and contact your doctor.
• Talk to your doctor if you think that your or your child’s bleeding is not being controlled with the dose you receive, as there can be several reasons for this. Some people using this medicine can develop antibodies to factor VIII (also known as factor VIII inhibitors). 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, stop the treatment from working properly and you or your child will be monitored carefully for the development of these inhibitors.

Cardiovascular events

If you have heart disease or are at risk for heart disease, take special care when using factor VIII medicines and talk to your doctor.

Catheter-related complications

If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.

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

If you are pregnant or breastfeeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

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

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

The usual dose of ALTUVOCT is 50 international units (IU) per kg of body weight. The injection is given weekly.

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

ALTUVOCT can be used in children 2 years and above, the dose recommendation is the same as in adults.

ALTUVOCT is given as an injection into a vein. See ‘Instructions on how to use ALTUVOCT’ for more information.

Tell your doctor as soon as possible. You should always use ALTUVOCT exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

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

If you stop using ALTUVOCT you may no longer be protected against bleeding or a current bleed may not stop. Do not stop using ALTUVOCT without talking to your doctor.

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:

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is efanesoctocog alfa (recombinant human coagulation factor VIII). Each vial of ALTUVOCT contains nominally 250, 500, 750, 1 000, 2 000, 3 000 or 4 000 IU efanesoctocog alfa.
• The other ingredients are sucrose, calcium chloride dihydrate, histidine, arginine hydrochloride, polysorbate 80.

ALTUVOCT is provided as a powder and solvent for solution for injection. The powder is a white to off-white powder or cake. The solvent provided for preparation of the solution to inject, is a clear, colourless solution. After preparation, the solution to inject is clear and colourless to slightly opalescent.

Each pack of ALTUVOCT contains 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, and 1 infusion set.

Check you have the correct product name and strength and are aware of the dosing frequency for ALTUVOCT.

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

ALTUVOCT should not be mixed with other solutions for injection.

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 all parts for damage before use, do not use if they appear damaged.

All parts are single use only.

Wash your hands and clean a flat surface before kit preparation. Place syringe safely on a clean surface when not being handled.

ALTUVOCT is reconstituted by dissolving the powder for injection (A) in the solvent supplied in the pre-filled syringe (B). ALTUVOCT solution should then be administered using the infusion set (E).

Ensure you have alcohol swabs (F) available.

Your pharmacist may have provided a separate large syringe (G) to draw up the solution from multiple vials into a single syringe. If a large syringe is NOT provided, follow steps 6 to 8 to administer the solution from each syringe.

1. Prepare the vial

a. Remove the vial cap

Hold the powder vial (A) on a clean flat surface and remove the plastic cap.

b. Clean vial top

Wipe the top of the vial with an alcohol swab.

After cleaning, ensure nothing touches the top of the vial.

c. Open vial adapter package

Peel off the protective paper lid from the vial adapter package (D).

Do not touch the vial adapter, or remove it from its package.

d. Attach vial adapter

Place the vial adapter package squarely over the top of the vial.

Press down firmly until the adapter snaps into place. The spike will penetrate the vial stopper.

2. Prepare the syringe

a. Attach plunger rod

Insert the plunger rod (C) into the 3 mL syringe (B). Turn the plunger rod clockwise until it is securely attached.

b. Remove syringe cap

Snap off the top part of white 3 mL syringe cap at the perforations and set aside.

Do not touch the inside of cap or the syringe tip.

3. Attach syringe to vial

a. Remove vial adapter package

Lift the package away from the vial adapter and dispose.

b. Attach syringe to vial adapter

Hold the vial adapter at the lower end. Place the syringe tip onto the top of the vial adapter. Turn the syringe clockwise to securely attach.

4. Dissolve the powder and solvent

a. Add solvent to vial

Slowly press the plunger rod to inject all the solvent into the vial.

b. Dissolve powder

With your thumb on the plunger rod, gently swirl the vial until powder is dissolved.

Do not shake.

c. Inspect solution

Inspect the solution before administration. It should be clear and colourless.

Do not use the solution if cloudy or contains visible particles.

5. If using multiple vials

If your dose requires multiple vials, follow the steps below (5a and 5b) otherwise skip to step 6.

a. Repeat 1 to 4

Repeat steps 1 to 4 with all vials until you have prepared enough solution for your dose.

Remove the 3 mL syringes from each vial (see step 6b), leaving the solution in each vial.

b. Using large syringe (G) provided by pharmacist

For each vial, attach the large syringe (G) to the vial adapter (see step 3b) and perform step 6, to combine the solution from each vial into the large syringe. In case you only need part of an entire vial, use the scale on the syringe to see how much solution you withdraw, as instructed by your healthcare professional.

6. Draw solution into syringe

a. Draw back solution

Point the syringe up. Slowly pull the plunger rod to draw all the solution into the syringe.

b. Detach syringe

Detach the syringe from the vial by holding the vial adapter. Turn the syringe anticlockwise to detach.

7. Prepare for injection

a. Remove tubing cap

Open infusion set (E) packaging (do not use if damaged).

Remove the tubing cap.

Do not touch the exposed end of the tubing set.

b. Attach syringe

Attach prepared syringe to the end of the infusion set tubing by turning the syringe clockwise.

c. Prepare injection site

If needed apply a tourniquet. Wipe injection site with an alcohol swab (F).

d. Remove air from syringe and tubing

Remove air by pointing the syringe up and gently pressing the plunger rod. Do not push the solution through the needle.

Injecting air into the vein can be dangerous.

8. Inject solution

a. Insert needle

Remove protective needle cover.

Insert the needle into a vein as instructed by your doctor or nurse and remove the tourniquet if used.

You may use a plaster to hold the plastic wings of the needle in place at the injection site to prevent movement.

b. Inject solution

The prepared solution should be injected intravenously over 1 to 10 minutes, based on your comfort level.

9. Dispose safely

a. Remove needle

Remove the needle. Fold over the needle protector; it should snap into place.

b. Safe disposal

Safely dispose of the used needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container.

Do not reuse equipment.