Product Information for the User
ADYNOVI 250 IU/5 ml powder and solvent for solution for injection
ADYNOVI 500 IU/5 ml powder and solvent for solution for injection
ADYNOVI 1 000 IU/5 ml powder and solvent for solution for injection
ADYNOVI 2 000 IU/5 ml powder and solvent for solution for injection
ADYNOVI 3 000 IU/5 ml powder and solvent for solution for injection
rurioctocog alfa pegol (recombinant human coagulation factor VIII pegylated)
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 adverse effects.
Read this leaflet carefully before you start using this medicine, because it contains important information for you.
ADYNOVI contains the active ingredient rurioctocog alfa pegol, pegylated human coagulation factor VIII. Human coagulation factor VIII has been modified to prolong the duration of its action. Human coagulation factor VIII is necessary for blood to form clots and to stop bleeding. In patients with hemophilia A (congenital deficiency of factor VIII), it is either absent or does not function correctly.
ADYNOVI is used for the treatment and prevention of bleeding in patients 12 years of age and older with hemophilia A (an inherited bleeding disorder caused by the absence of factor VIII)
No use ADYNOVi
If you have any doubts, consult your doctor.
Warnings and precautions
It is essential to keep a record of the batch number of your ADYNOVI. Therefore, each time you receive a new package of ADYNOVI, note the date and batch number (which is on the packaging after the abbreviation "Batch") and store this information in a safe place.
Consult your doctor before starting to use ADYNOVI.
There is a very small risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADYNOVI. You should be aware of the initial signs of allergic reactions, such as rash, urticarial hives, itching, swelling of the lips and tongue, difficulty breathing, wheezing, chest tightness, general feeling of discomfort, and dizziness. These could be initial symptoms of anaphylactic shock. Other symptoms may include intense dizziness, loss of consciousness, and severe difficulty breathing.
If any of these symptoms appear, stop the injection immediately and consult your doctor. Severe symptoms, such as difficulty breathing and (pre)syncope, require urgent treatment.
If you have any heart disease, inform your doctor, as there is a higher risk of complications due to blood clot formation.
Patients who develop factor VIII inhibitors
The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medications. These inhibitors, especially in large quantities, prevent the treatment from working properly, so you and your child will be closely monitored for the development of these inhibitors. If your bleeding or your child's bleeding is not being controlled with ADYNOVI, consult your doctor immediately.
Complications related to the catheterIf you need to use a central venous catheter (CVC), the risk of complications related to this device, such as local infections, presence of bacteria in the blood, and thrombosis in the catheter area, should be taken into account.
Children and adolescents
ADYNOVI can only be used in adolescents and adults (over 12 years old). The warnings and precautions listed also apply to adolescents.
Other medications and ADYNOVI
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 if you think you may be pregnant, consult your doctor before using this medication. Hemophilia A rarely affects women, so there is no experience with the use of ADYNOVI during pregnancy and breastfeeding.
Driving and operating machinery
The influence of ADYNOVI on the ability to drive and operate machinery is negligible or insignificant.
ADYNOVI contains sodium
ADYNOVI contains up to 12.42 mg of sodium (main component of table salt/for cooking) per vial. This is equivalent to 0.62% of the maximum daily sodium intake recommended for an adult. Depending on your body weight and your ADYNOVI dose, you may receive more than one vial. This should be taken into account if you follow a low-sodium diet.
Your doctor will initiate and supervise your treatment with ADYNOVI, and they should be experienced in treating patients with hemophilia A.
Your doctor will calculate your dose of ADYNOVI based on your condition and body weight, and whether it is for prevention or treatment of bleeding. The frequency of administration will depend on how ADYNOVI works in your case. ADYNOVI treatment is usually a lifelong treatment.
Follow exactly the administration instructions for this medication as indicated by your doctor. If you are unsure, consult your doctor again.
Bleeding prevention
The usual dose of ADYNOVI is 40 to 50 UI per kg of body weight, administered 2 times a week.
Bleeding treatment
The dose of ADYNOVI will be calculated based on your body weight and the desired levels of factor VIII. The desired 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 the necessary laboratory tests to ensure you have the appropriate levels of factor VIII. 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 old). The dose for adolescents is also calculated based on body weight and is the same as for adults.
How to administer ADYNOVI
Normally, your doctor or nurse will inject ADYNOVI into a vein (intravenous route). You or someone else can 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 as indicated by your doctor. Consult your doctor if you are unsure. If you inject a higher dose of ADYNOVI than recommended, consult your doctor as soon as possible.
If you forget to use ADYNOVI
Do not inject a double dose to make up for the missed dose. Administer the next injection as scheduled and continue as your doctor had instructed.
If you interrupt treatment with ADYNOVI
Do not stop using ADYNOVI without consulting your doctor.
If you have any other questions about using this medication, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experiencesevere and sudden allergic reactions (anaphylaxis),stop the injection immediately.Contact your doctor immediatelyif you have any of the following initial symptoms of allergic reactions:
Severe symptoms, such as difficulty breathing and near fainting, require immediate urgent treatment
In patients who have received previous treatment with factor VIII (more than 150 days of treatment), antibodies inhibitors (see section 2) may form with a low frequency (less than 1 in 100 patients). If this happens, the medicine you take may not work properly and you may experience persistent bleeding. In that case, contact your doctor immediately.
Very common side effects(can affect more than 1 in 10 people)
Headache
Frequent side effects(can affect up to 1 in 10 people)
Nausea
Diarrhea
Eruption
Dizziness
Urticarial rash
Uncommon side effects(can affect up to 1 in 100 people)
Redness, allergic reaction (hypersensitivity)
Factor VIII inhibitors (in patients who have received previous treatment with factor VIII (more than 150 days of treatment))
Increased levels of some white blood cells
Reaction to infusion
Eye redness
Adverse skin reaction
Other side effects in children
The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of side effects
If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification 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 label and the box after CAD. The expiration date is the last day of the month indicated.
Store in refrigerator (between 2 °C and 8 °C).
Do not freeze.
Store blister in the outer packaging to protect it from light.
During its period of validity, the vial of powder can be stored at room temperature (up to 30 °C) for a single period that does not exceed 3 months. In that case, this medication expires at the end of this 3-month period or on the expiration date printed on the product vial, whichever occurs first. Please note on the outer packaging the date of the end of the 3-month storage period at room temperature. The medication cannot be refrigerated again after being stored at room temperature. Do not refrigerate the medication after preparation.
Use the medication within 3 hours after complete dissolution of the powder.
This medication is for single use. Dispose of unused solution properly
Medicines should not be thrown away 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 ADYNOVI
Appearance of the product and contents of the pack
ADYNOVI is supplied as a powder and solvent for injection (powder for solution for injection). The powder is a white to off-white powder that dissolves. The solvent is a colourless transparent solution. After reconstitution, the solution is transparent, colourless and free of foreign particles.
Marketing authorisation holder
Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Manufacturer
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
B-7860 Lessines
Belgium
For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
België/Belgique/Belgien Takeda Belgium NV Tel/Tél: +32 2 464 06 11 | Lietuva Takeda, UAB Tel: +370 521 09 070 |
Luxembourg/Luxemburg Takeda Belgium NV Tel/Tél: +32 2 464 06 11 | |
Ceská republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 722 | Magyarország Takeda Pharma Kft. Tel: +36 1 270 7030 |
Danmark Takeda Pharma A/S Tlf: +45 46 77 10 10 | Malta Τakeda HELLAS S.A. Tel: +30 210 6387800 |
Deutschland Takeda GmbH Tel: +49 (0)800 825 3325 | Nederland Takeda Nederland B.V. Tel: +31 20 203 5492 |
Eesti Takeda Pharma AS Tel: +372 6177 669 | Norge Takeda AS Tlf: +47 800 800 30 |
Ελλάδα Τakeda ΕΛΛΑΣ Α.Ε. Tηλ: +30 210 6387800 | Österreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 50 [email protected] |
España Takeda Farmacéutica España, S.A Tel: +34 917 90 42 22 | Polska Takeda Pharma Sp. z o.o. tel: +48223062447 |
France Takeda France SAS Tel. + 33 1 40 67 33 00 | Portugal Takeda Farmacêuticos Portugal, Lda. Tel: + 351 21 120 1457 |
Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 96 | România Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91 |
Ireland Takeda Products Ireland Ltd Tel: 1800 937 970 | |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 600 |
Italia Takeda Italia S.p.A. Tel: +39 06 502601 | Suomi/Finland Takeda Oy Puh/Tel: 0800 774 051 |
Κύπρος Proton Medical (Cyprus) Ltd Τηλ: +357 22866000 | Sverige Takeda Pharma AB Tel: 020 795 079 |
Latvija Takeda Latvia SIA Tel: +371 67840082 | United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 902 |
Last update of the summary of product characteristics:
The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/
Instructions for preparation and administration
ADYNOVI must not be mixed with other medicinal products or solvents.
It is strongly recommended to record the name and batch number of the product each time ADYNOVI is administered. The blister pack has labels that can be removed.
Instructions for reconstitution
Instructions for injection
During administration, a sterile technique (in conditions of cleanliness and few microorganisms) is required.
Important note:
Do not use if the solution is not completely transparent or the product is not completely dissolved.
This information is intended solely for healthcare professionals
On-demand treatment
In the case of subsequent bleeding episodes, the factor VIII activity must not be less than the given plasma activity level (in % of normal or IU/dl) in the corresponding period. The following table can be used as a dosing guide for surgery and bleeding episodes:
Table 1: Dosing guide for on-demand treatment in bleeding episodes and surgery
Bleeding episode/surgical procedure | Required factor VIII level (% or IU/dl) | Dosing frequency (hours)/treatment duration (days) |
BleedingIncipient haemarthrosis or oral or muscular bleeding. | 20 – 40 | Repeat injections every 12 to 24 hours. At least 1 day, until the bleeding episode has resolved, based on pain, or until healing has occurred. |
More extensive haemarthrosis, muscular bleeding or haematoma | 30 – 60 | Repeat injections every 12 to 24 hours for 3–4 days or more until pain and acute disability have resolved. |
Life-threatening bleeding episodes. | 60 – 100 | Repeat injections every 8 to 24 hours until the risk has disappeared. |
Surgery Minor Including dental extraction | 30 – 60 | Every 24 hours for at least 1 day, until healing has occurred. |
Major | 80 – 100 (pre and postoperative) | Repeat injections every 8 to 24 hours until the wound has healed adequately and continue treatment for at least another 7 days to maintain a factor VIII activity level of 30% to 60% (IU/dl). |
Prophylaxis
For long-term prophylaxis, the recommended dose is 40 to 50 IU of ADYNOVI per kg of body weight twice a week at intervals of 3 to 4 days. Dose adjustments and administration intervals may be considered based on factor VIII levels obtained and individual bleeding trends.
Pediatric population
The dosing guide for on-demand treatment in pediatric patients (12 to 18 years of age) is the same as for adult patients. The prophylactic treatment for patients 12 to <18>
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