AltuvocT 3 000 IU powder and solvent for solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
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 quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What ALTUVOCT is and what it is used for
- What you need to know before using ALTUVOCT
- How to use ALTUVOCT
- Possible side effects
- How to store ALTUVOCT
- Contents of the pack and other information
1. What ALTUVOCT is and what it is used for
ALTUVOCT contains the active substance efanesoctocog alfa, a replacement protein for factor VIII.
ALTUVOCT is used to treat and prevent bleeding episodes in patients with haemophilia A (an inherited bleeding disorder caused by factor VIII deficiency), and can be used in patients of all age groups.
Factor VIII is a protein that occurs naturally in the body and is necessary for blood to clot and stop bleeding. In patients with haemophilia A, factor VIII is missing or does not function properly.
ALTUVOCT replaces this deficient or missing factor VIII. ALTUVOCT increases factor VIII concentrations in the blood, thereby helping blood to form clots at the site of bleeding, temporarily correcting the tendency to bleed.
2. What you need to know before starting to use ALTUVOCT
Do not use ALTUVOCT
- if you are allergic to efmoroctocog 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 to use ALTUVOCT.
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There is a rare possibility that you may experience hypersensitivity reactions, including anaphylactic reactions (a severe and sudden allergic reaction) to ALTUVOCT. Signs of allergic reactions include generalized itching, hives, feeling of tightness in the chest, difficulty breathing, and low blood pressure. If any of these symptoms occur, stop the infusion immediately and contact your doctor.
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Consult your doctor if you think that your bleeding or your child's bleeding is not being controlled with the current dose, 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 may occur during treatment with all factor VIII medicines. These inhibitors, especially at high levels, can prevent the treatment from working properly; you or your child will therefore be closely monitored for the development of such inhibitors.
Cardiovascular events
If you have heart disease or are at risk of developing it, take special care when using factor VIII medicines and consult your doctor.
Catheter-related complications
If a central venous access device (CVAD) is required, the risk of CVAD-related complications should be considered, including local infections, presence of bacteria in the blood (bacteraemia), and thrombosis at the catheter insertion site.
Other medicines and ALTUVOCT
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Driving and using machines
The influence of ALTUVOCT on the ability to drive and use machines is none or negligible.
3. How to use ALTUVOCT
ALTUVOCT treatment will be initiated by a doctor experienced in managing patients with hemophilia A. ALTUVOCT is administered by intravenous injection.
After receiving adequate training in the correct injection technique, patients or caregivers may administer ALTUVOCT at home. Your doctor will calculate your dose (in international units [IU]), which will depend on your body weight and whether it is being used for prophylaxis or treatment of bleeding episodes.
Always follow exactly the administration instructions provided by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.
Keep a record
Each time you use ALTUVOCT, record the date, the name of the medicine, 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 weekly.
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 depending on the severity and location of the bleeding.
Use in children and adolescents
ALTUVOCT can be used in children of all ages; the recommended dosing is the same as in adults.
How ALTUVOCT is administered
ALTUVOCT is administered by intravenous injection. See "Instructions for how to use ALTUVOCT" for further information.
If you use more ALTUVOCT than you should
Inform your doctor as soon as possible. Always follow exactly the administration instructions provided by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.
If you forget to use ALTUVOCT
Do not inject a double dose to make up for the missed dose. Inject your dose as soon as you remember, and then resume your normal dosing schedule. If you are unsure what to do, consult your doctor, pharmacist, or nurse.
If you stop using ALTUVOCT
If you stop treatment with ALTUVOCT, you may no longer be protected against bleeding episodes, or an existing bleed may not stop. Do not discontinue treatment with ALTUVOCT without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
If hypersensitivity reactions, including anaphylactic reactions, occur, the injection must be stopped immediately and you should contact your doctor immediately.
Symptoms of hypersensitivity reactions/anaphylactic reactions include, among others, the following:
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Risk of inhibitor formation
In children who have not previously received factor VIII medications, the development of inhibitor antibodies (see section 2) is very common (may affect more than 1 in 10 patients); however, in patients who have previously received factor VIII treatment (more than 150 days of treatment), the risk is uncommon (may affect up to 1 in 100 patients). If you or your child develop inhibitor antibodies, the medicine may no longer work effectively and you or your child may experience persistent bleeding. If this occurs, you must contact your doctor immediately.
The following adverse effects may occur with this medicine.
Very common adverse effects (may affect more than 1 in 10 people)
- headache
- arthralgia (joint pain)
Common adverse effects (may affect up to 1 in 10 people)
- pain in limbs (arms, hands, legs, or feet)
- back pain
- eczema (itching, redness, or dry skin)
- skin rash
- urticaria (itchy rash)
- fever
- vomiting
Uncommon adverse effects (may affect up to 1 in 100 people)
- reactions at the injection site (including bruising and inflammation)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 stated on the carton and vial following «CAD/EXP». The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect it from light.
Prior to reconstitution, the ALTUVOCT powder may be stored at room temperature (≤ 30 °C) for a single period not exceeding 6 months. The date when the medicine is removed from the refrigerator must be recorded on the carton. After storage at room temperature, the medicine must not be returned to the refrigerator.
The medicine must not be used after the expiry date printed on the vial or 6 months after removal of the carton from the refrigerator, whichever occurs first.
Once the ALTUVOCT powder has been dissolved in the solvent supplied 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 it appears cloudy or contains visible particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.
6. Contents of the pack and other information
Composition of ALTUVOCT
- 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 of efanesoctocog alfa.
- The other components are sucrose, calcium chloride dihydrate, histidine, arginine hydrochloride, and polysorbate 80.
Presentation of the product and contents of the pack
ALTUVOCT is presented as a powder and solvent for solution for injection. The powder is a loose or compact powder ranging from white to off-white in colour. The solvent supplied for the preparation of the injection solution is a clear, colourless solution. After reconstitution, the injection solution is clear and colourless to slightly opalescent.
Each pack of ALTUVOCT contains 1 vial of powder, 3 ml of solvent in a pre-filled syringe, 1 syringe plunger rod, 1 vial adapter, and 1 infusion set.
Marketing Authorisation Holder
Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm
Sweden
Manufacturer
Swedish Orphan Biovitrum AB (publ)
Norra Stationsgatan 93
113 64 Stockholm
Sweden
Date of the most recent revision of this leaflet:
Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
Turn over the leaflet to see instructions for the preparation and administration of the medicine.
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 pre-filled syringe.
If your dose requires more than one vial, you will receive several packs and, ideally, a larger syringe.
Your healthcare professional must teach you how to properly prepare and inject ALTUVOCT before you use it for the first time. Ask your healthcare professional if you have any questions.
Important information
Check that the medicine name and dose are correct and that you know how frequently ALTUVOCT should be administered.
Do not use the medicine if it has expired, has been opened, or appears damaged.
ALTUVOCT must not be mixed with other injectable solutions.
ALTUVOCT should ideally be stored in the refrigerator. Allow the vial and the solvent syringe to reach room temperature before use. Do not use external heat sources.
Check that none of the components are damaged before use; do not use them if they appear damaged.
All components are intended 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 the components (included in the pack)
ALTUVOCT is reconstituted by dissolving the injectable powder (A) in the solvent supplied in the pre-filled syringe (B). The ALTUVOCT solution should then be administered using the infusion set (E).
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Additional items (not included in the pack)
Make sure you have alcohol wipes (F).
Your pharmacist may have provided you with a large syringe separately (G) to withdraw the solution from several vials into a single syringe. If a large syringe has NOT been provided, follow steps 6 to 8 to administer the solution from each syringe.
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Reconstitution
1. | Prepare the vial | |
a. | Remove the vial cap Hold the powder vial (A) on a clean, flat surface and remove the plastic closure cap. |
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b. | Clean the top of the vial Clean the top of the vial with an alcohol wipe. Ensure nothing touches the top of the vial once cleaned. |
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c. | Open the vial adapter package Peel back the paper protective cover from the vial adapter package (D). Do not touch the vial adapter or remove it from its package. |
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d. | Attach the vial adapter Place the vial adapter package directly onto the top of the vial. Press down firmly until the adapter snaps into place. The puncturing pin will pierce the vial stopper. |
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2. | Prepare the syringe | |
a. | Attach the plunger rod Insert the plunger rod (C) into the 3 mL syringe (B). Rotate the plunger rod clockwise until securely attached. |
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b. | Remove the syringe cap Separate the upper part of the syringe cap along the perforations and set it aside. Do not touch the inside of the syringe cap or the tip of the syringe. |
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3. | Attach the syringe to the vial | |
a. | Remove the vial adapter package Lift off the package from the vial adapter and discard it. |
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b. | Attach the syringe to the vial adapter Hold the vial adapter by the bottom end. Place the syringe tip onto the top of the vial adapter. Rotate the syringe clockwise until securely attached. |
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4. | Reconstitute the powder and diluent | |
a. | Add diluent to the vial Slowly push the plunger rod to inject all the diluent into the vial. |
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b. | Reconstitute the powder With your thumb on the plunger rod, gently swirl the vial until the powder is completely dissolved. Do not shake. |
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c. | Inspect the solution Inspect the solution before administration. It should be clear and colorless. Do not use the solution if it is cloudy or contains visible particles. | |
5. | If using more than one vial | |
If your dose requires more than one vial, follow the steps below (5a and 5b); otherwise, proceed to step 6. | ||
a. | Repeat steps 1 to 4 Repeat steps 1 to 4 with all vials until you have prepared a sufficient amount of solution for your dose. Remove the 3 mL syringes from each vial (see step 6b), leaving the solution in each vial. |
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b. | Use of a large syringe (G) provided by the 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. If you only need part of a full vial, use the syringe’s graduation scale to measure the amount of solution withdrawn, as instructed by your healthcare provider. |
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6. | Withdraw the solution into the syringe | |
a. | Withdraw the solution Hold the syringe with the tip pointing upward. Slowly pull back the plunger rod to draw all the solution into the syringe. |
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b. | Detach the syringe Detach the syringe from the vial by holding the vial adapter. Rotate the syringe counterclockwise to unattach it. |
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Administration
7. | Prepare for injection | |
a. | Remove the closure cap from the tubing Open the infusion set package (E) (do not use if damaged). Remove the closure cap from the tubing.
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b. | Attach the syringe Attach the prepared syringe to the end of the infusion set tubing by turning the syringe clockwise. |
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c. | Prepare the injection site If necessary, apply a tourniquet. Clean the injection site with an alcohol wipe (F). |
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d. | Remove air from the syringe and tubing Remove air by holding the syringe upright and gently pressing the plunger. Do not push solution through the needle.
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8. | Inject the solution | |
a. | Insert the needle Remove the protective needle cap. Insert the needle into a vein as instructed by your doctor or nurse, and remove the tourniquet if one was applied. You may use a bandage to secure the plastic wings of the needle in place at the injection site to prevent movement. | |
b. | Inject the solution The prepared solution should be administered intravenously over 1 to 10 minutes, depending on patient comfort. | |
9. | Dispose of materials safely | |
a. | Remove the needle Remove the needle. Fold the needle protector over; it should lock into place. |
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b. | Safe disposal Safely dispose of the used needle, any unused solution, the syringe, and the empty vial in an appropriate medical waste container.
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