Adynovi 500 IU/2 ml powder and solvent for solution for injection
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ADYNOVI 250 IU/2 ml powder and solvent for solution for injection
ADYNOVI 500 IU/2 ml powder and solvent for solution for injection
ADYNOVI 1000 IU/2 ml powder and solvent for solution for injection
rurioctocog alfa pegol (recombinant pegylated human coagulation factor VIII)
This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 includes information on how to report adverse reactions.
Read all of this leaflet carefully before you start using this medicine, because 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.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, even if they are possible adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What ADYNOVI is and what it is used for
- What you need to know before using ADYNOVI
- How to use ADYNOVI
- Possible adverse reactions
- How to store ADYNOVI
- Contents of the pack and other information
1. What ADYNOVI is and what it is used for
ADYNOVI contains the active substance rurioctocog alfa pegol, a pegylated human coagulation factor VIII. Human coagulation factor VIII has been modified to prolong its duration of action. Factor VIII is necessary for blood to form clots and to stop bleeding. In patients with haemophilia A (an inherited deficiency of factor VIII), factor VIII is either missing or does not function properly.
ADYNOVI is used for the treatment and prevention of bleeding in patients aged 12 years and older with haemophilia A (an inherited bleeding disorder caused by the absence of factor VIII).
2. What you need to know before using ADYNOVI
Do not use ADYNOVI:
- if you are allergic to rurioctocog alfa pegol, octocog alfa, or to any of the other components of this medicine (listed in section 6)
- if you are allergic to mouse or hamster proteins
If you have any doubts, consult your doctor.
Warnings and precautions
Talk to your doctor before starting to use ADYNOVI.
There is a very small risk that you may experience an anaphylactic reaction (a sudden, severe allergic reaction) to ADYNOVI. You should be aware of the early signs of allergic reactions, such as rash, hives, welts, widespread itching, swelling of the lips and tongue, difficulty breathing, wheezing, chest tightness, general feeling of discomfort, and dizziness. These could be early symptoms of anaphylactic shock. Other symptoms may include severe dizziness, loss of consciousness, and severe difficulty breathing.
If any of these symptoms occur, stop the infusion immediately and contact your doctor. Severe symptoms such as difficulty breathing and (pre) fainting require urgent medical treatment.
If you have any heart condition, inform your doctor, as there is an increased risk of complications due to blood clot formation.
Patients who develop factor VIII inhibitors
The development of inhibitors (antibodies) is a known complication that may occur during treatment with all factor VIII-containing medicines. These inhibitors, especially when present in high amounts, may prevent the treatment from working properly. Therefore, you or your child will be closely monitored for the development of inhibitors. If your bleeding or your child's bleeding is not controlled by ADYNOVI, contact your doctor immediately.
Catheter-related complications
If a central venous catheter (CVC) is required, the risk of complications associated with this device should be considered, such as local infections, presence of bacteria in the blood, and catheter-related thrombosis.
Children and adolescents
ADYNOVI can only be used in adolescents and adults (over 12 years of age). The warnings and precautions mentioned also apply to adolescents.
Other medicines and ADYNOVI
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 might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Haemophilia A rarely affects women. Therefore, there is no experience regarding the use of ADYNOVI during pregnancy and breastfeeding.
Driving and using machines
ADYNOVI has no influence on the ability to drive or operate machinery.
ADYNOVI contains sodium
This medicine contains 0.45 mmol of sodium (10 mg) per vial. This should be taken into account in patients on sodium-restricted diets.
3. How to use ADYNOVI
Treatment with ADYNOVI will be initiated and supervised by a physician experienced in the treatment of patients with haemophilia A.
Your doctor will calculate your ADYNOVI dose based on your condition, body weight, and whether it is used for prevention or treatment of bleeding. The frequency of administration will depend on how ADYNOVI works in your individual case. Replacement therapy with ADYNOVI is usually a lifelong treatment.
Follow exactly the dosing instructions for this medicine provided by your doctor. If in doubt, consult your doctor again.
Prevention of bleeding
The usual dose of ADYNOVI is 40 to 50 IU per kg of body weight, administered twice weekly.
Treatment of bleeding
The dose of ADYNOVI is calculated based on your body weight and the factor VIII levels you need to achieve. The required factor VIII levels will depend on the severity and location of the bleeding.
Consult your doctor if you think the effect of ADYNOVI is insufficient.
Your doctor will perform appropriate laboratory tests to ensure you have adequate factor VIII levels. This is especially important if you are undergoing major surgery.
Use in children and adolescents
ADYNOVI can only be used in adolescents and adults (over 12 years of age). The dose for adolescents is also calculated according to body weight and is the same as for adults.
How ADYNOVI is administered
ADYNOVI is usually injected into a vein (intravenous route) by a doctor or nurse. You or another person may also administer the ADYNOVI injection, but only after receiving proper training. Detailed instructions for self-administration are described at the end of this leaflet.
If you use more ADYNOVI than you should
Follow exactly the administration instructions for ADYNOVI provided by your doctor. Consult your doctor if you have any doubts. If you inject a higher dose of ADYNOVI than recommended, contact your doctor as soon as possible.
If you forget to use ADYNOVI
Do not inject a double dose to make up for a missed dose. Administer the next injection as scheduled and continue as directed by your doctor.
If you stop using ADYNOVI
Do not stop using ADYNOVI without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If severe and sudden allergic (anaphylactic) reactions occur, the injection must be stopped immediately. Contact your doctor immediately if you experience any of the following initial symptoms of allergic reactions:
- rash, urticaria, hives, generalized itching,
- swelling of lips and tongue,
- difficulty breathing, noisy breathing, chest tightness,
- general feeling of malaise,
- dizziness and loss of consciousness.
Severe symptoms such as difficulty breathing and (near) fainting require immediate emergency treatment.
In patients who have previously received treatment with factor VIII (more than 150 days of treatment), inhibitor antibodies may form infrequently (less than 1 in 100 patients) (see section 2). If this occurs, the medicine you are taking may no longer work properly and you may experience persistent bleeding. In this case, contact your doctor immediately.
Common side effects (may affect up to 1 in 10 people)
Headache, nausea, diarrhoea, rash
Uncommon adverse reactions (may affect up to 1 in 100 people)
Flushing, allergic reaction (hypersensitivity)
Factor VIII inhibitors (in patients previously treated with factor VIII (more than 150 days of treatment))
Other adverse reactions in children
The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of ADYNOVI
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton following EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 ºC and 8 ºC).
Do not freeze.
Keep the blister pack in the outer packaging to protect it from light.
During its shelf life, the vial of powder may be stored at room temperature (up to 30 ºC) for a single period not exceeding 3 months. In such case, this medicine expires at the end of this 3-month period or on the expiry date printed on the product vial, whichever comes first. Please record on the medicine container the date marking the end of the 3-month room temperature storage period. The medicine must not be refrigerated again after being stored at room temperature. Do not refrigerate the medicine after reconstitution.
Use the medicine within 3 hours after complete dissolution of the powder.
This medicine is for single use only. Any unused solution should be properly discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of ADYNOVI
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The active substance is rurioctocog alfa pegol (recombinant DNA-derived human coagulation factor VIII). Each vial of powder contains nominally 250, 500, or 1000 IU of rurioctocog alfa pegol.
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The solvent contains 2 ml of sterile water for injectable preparations.
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The other ingredients are mannitol, trehalose dihydrate, histidine, glutathione, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80, and sterile water for injectable preparations. ADYNOVI contains sodium; see section 2.
Appearance of the product and contents of the pack
ADYNOVI is supplied as a powder and solvent for injectable solution. The powder is a white to off-white, friable powder. The solvent is a clear, colourless solution. After reconstitution, the solution is clear, colourless, and free from foreign particles.
Marketing Authorization Holder
Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Tel: +44(0)1256 894 959
Email: [email protected]
Manufacturer
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
B-7860 Lessines
Belgium
Date of the most recent review of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Instructions for preparation and administration
ADYNOVI must not be mixed with other medicines or solvents.
It is strongly recommended to record the name and batch number of the product each time ADYNOVI is administered. The blister pack includes removable labels.
Instructions for reconstitution
- Do not use after the expiry date stated on the labels and packaging.
- Do not use if the blister pack seal is not intact.
- Do not refrigerate the medicine after preparation.
- If the medicine is still in the refrigerator, remove the sealed blister (containing the pre-assembled powder and solvent vials in the reconstitution system) and allow it to reach room temperature (between 15 °C and 25 °C).
- Wash hands with soap and lukewarm water.
- Open the ADYNOVI blister by removing the lid. Remove the BAXJECT III system from the blister.
- Place the powder vial on a flat surface with the solvent vial on top (Figure 1). The solvent vial has a blue mark. Do not remove the blue protector until instructed later.
- While holding the powder vial with one hand in the BAXJECT III system, press firmly with the other hand on the solvent vial until the system is fully compressed and the solvent flows into the powder vial (Figure 2). Do not tilt the system until transfer is complete.
- Confirm that solvent transfer is complete. Gently swirl until all material is dissolved (Figure 3). Check that the powder is completely dissolved; if not, the entire reconstituted solution will not pass through the device filter. The medicine dissolves rapidly (usually within less than 1 minute). After reconstitution, the solution should be clear, colourless, and free from foreign particles.
Figure 1 | Figure 2 | Figure 3 |
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Injection Instructions
During administration, an antiseptic technique must be used (under clean conditions with minimal exposure to germs).
Important Note:
- Examine the prepared solution for particles or discoloration prior to administration (the solution should be clear, colorless, and free of particles).
Do not use if the solution is not completely transparent or if the product is not fully dissolved.
- Remove the blue protector from the BAXJECT III device. Do not introduce air into the syringe. Attach the syringe to the BAXJECT III. Use of a Luer-lock syringe is recommended.
- Turn the system upside down (with the vial of powder above). Draw the reconstituted solution into the syringe by slowly pulling back the plunger.
- Disconnect the syringe, attach a butterfly needle to the syringe, and inject the reconstituted solution into a vein. The solution should be administered slowly, at a rate determined according to the patient's comfort level, not exceeding 10 ml per minute. (See section 4, "Possible adverse effects".)
- Dispose of any unused solution appropriately.
This information is intended for healthcare professionals only:
On-demand treatment
For the following bleeding episodes, factor VIII activity should not fall below the plasma activity level indicated (in % of normal or IU/dL) during the corresponding period. The following table may be used as a dosing guideline for surgery and bleeding episodes:
Table 1 Dosage regimen guidelines for bleeding episodes and surgery | ||
Degree of bleeding/surgical procedure type | Required factor VIII level (% or IU/dL) | Dosing frequency (hours)/duration of treatment (days) |
Bleeding | ||
Early hemarthrosis or muscle or oral bleeding. | 20–40 | Repeat injections every 12 to 24 hours. For at least 1 day, until the bleeding episode has resolved, based on pain, or until healing occurs. |
More extensive hemarthrosis, muscle bleeding, or hematoma | 30–60 | Repeat injections every 12 to 24 hours for 3–4 days or more, until acute pain and disability have resolved. |
Potentially life-threatening hemorrhages. | 60–100 | Repeat injections every 8 to 24 hours until the risk has passed. |
Surgery | ||
MinorIncluding dental extractions | 30–60 | Every 24 hours for at least 1 day, until healing occurs. |
Major | 80–100 (pre- and postoperative) | Repeat injections every 8 to 24 hours until the wound has adequately healed, and then continue treatment for at least another 7 days to maintain factor VIII activity between 30% and 60% (IU/dL). |
Prophylaxis
For long-term prophylaxis, the recommended dose is 40 to 50 IU of ADYNOVI per kg body weight twice weekly, administered at intervals of 3 to 4 days. Dose adjustments and administration intervals may be considered based on observed factor VIII levels and individual bleeding tendency (see section 5.2).
Paediatric population
The dosing regimen for on-demand treatment in paediatric patients (12 to 18 years of age) is the same as for adult patients. Prophylactic treatment for patients aged 12 to <18 years is the same as for adult patients. The long-term safety of ADYNOVI in children under 12 years of age has not yet been established. Dose adjustments and administration intervals may be considered based on observed factor VIII levels and individual bleeding tendency (see section 5.2).