250 IU, 500 IU, 1000 IU, 2000 IU, and 3500 IU powder and solvent for injection, solution
albutrepenonakog alpha ( recombinant coagulation factor IX)
1. What IDELVION is and what it is used for
What is IDELVION?
IDELVION is medicine for haemophilia that replaces natural coagulation factor (clotting factor) IX. The active substance in IDELVION is albutrepenone and alpha ( recombinant fusion protein linking coagulation factor IX to albumin (RIX-FP)).
Factor IX is involved in blood clotting. Patients with haemophilia B have a deficiency of this factor, which means that their blood cannot clot as quickly as it should and therefore there is an increased tendency to bleed. IDELVION works by replacing factor IX in patients with haemophilia B so that their blood can clot.
What is IDELVION used for?
IDELVION is used for preventing or stopping bleeding caused by a lack of functioning factor IX in patients of all ages with haemophilia B (also known as congenital factor IX deficiency or Christmas disease).
2. What you need to know before using IDELVION
Do not use IDELVION
- if you are allergic to the active substance (albutrepenonacog alfa) or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to hamster protein.
Warnings and cautions
It is strongly recommended that each time you use IDELVION make a note of the product name and batch number, in order to have control over which products and batches you have used.
Talk to your doctor, pharmacist, or nurse before using IDELVION.
- Allergic hypersensitivity reactions may occur. The product contains traces of hamster proteins (see also “Do not use IDELVION”). If symptoms of an allergic reaction occur, stop using the medicine immediately and contact your doctor or treatment center where you are being monitored . Your doctor should inform you of early signs of hypersensitivity reaction . These include hives, generalized skin rash, chest tightness, wheezing, low blood pressure ( hypotension ) and anaphylaxis (a severe allergic reaction that causes severe difficulty breathing or dizziness).
- Due to the risk of allergic reactions with factor IX, your first dose of IDELVION should be given under medical supervision where appropriate medical care for allergic reactions can be given.
- The formation of inhibitors ( antibodies ) is a known complication that has been reported during treatment with IDELVION. The inhibitors cause the treatment to stop working properly. Tell your doctor immediately if your bleeding cannot be controlled with IDELVION. You should be monitored regularly for the formation of inhibitors.
- If you have liver or heart disease or if you have recently had major surgery, tell your doctor as there is an increased risk of blood clots (coagulation).
- If you need to use a central venous catheter (CVK for injection of IDELVION), the risk of complications should be considered by your doctor, including local infections , bacteria in the blood ( bacteremia ) and the formation of blood clots in blood vessels ( thrombosis ) where the catheter is located.
Other medicines and IDELVION
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- During pregnancy and lactation, IDELVION should only be given if absolutely necessary.
Driving and using machines
IDELVION does not affect the ability to drive or use machines.
IDELVION contains sodium
This medicine contains up to 8.6 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 0.4% of the highest recommended daily intake of sodium for adults.
3. How to use IDELVION
Your treatment should be started and carried out under the supervision of a doctor who has experience in the treatment of bleeding disorders.
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Your doctor will calculate the dose you need of IDELVION. The amount of IDELVION you need and the treatment time depends on:
- the severity of your illness
- where the bleeding is and how extensive it is
- your clinical condition and treatment response
- your body weight.
IDELVION is administered by your doctor or nurse as an injection into a vein by intravenous, (iv) injection after reconstitution of the powder with the supplied solvent. You or someone else can also administer IDELVION as an IV injection, but only after receiving appropriate training.
If you use more IDELVION then you should
Contact your doctor immediately if you inject more IDELVION than your doctor recommended.
If you stop using IDELVION
Do not stop using IDELVION without consulting a doctor.
Preparation and administration
General instructions
- The powder must be mixed with the diluent and withdrawn from the vial while keeping the drug sterile (bacteria-free). Your doctor will show you how to prepare the solution and how to draw the solution correctly from the vial.
- IDELVION must not be mixed with other medicinal products or solutions other than those mentioned in section 6.
- The solution should be clear and slightly opalescent (semi-transparent), yellow to colorless, ie it may glisten if held up to the light but must not contain any visible particles. After filtering or filling the syringe (see below), the solution should be visually inspected before use. Do not use the solution if it is cloudy or contains flakes or particles.
- Any unused product or waste material should be disposed of in accordance with local requirements and as directed by your physician.
Preparation
Before opening the vials, IDELVION powder and liquid should be warmed to room or body temperature. This can be done either by allowing the bottles to stand at room temperature for about an hour or by holding them in your hands for a few minutes.
DO NOT expose the vials to direct heat. The vials must not be heated above body temperature (37 ºC).
Carefully remove the plastic lids from the bottles and clean the surfaces of the rubber stoppers with an alcohol wipe. Allow the vials to dry before opening the Mix2Vial package (containing the transfer kit with filter). Then follow the instructions below.
Commissioning and administration
Use the supplied venipuncture set and insert the needle into a vein. Let the blood flow back to the end of the tube. Attach the syringe to the threaded locking device at the end of the venipuncture set. Slowly inject the reconstituted solution into the vein (as convenient for you, up to a maximum of 5 ml/min), according to the instructions given to you by your doctor. Be careful not to get any blood into the syringe with a reconstituted solution.
See if you get any immediate side effects. If you experience any side effects that may be due to the administration of IDELVION, the injection should be discontinued (see also sections 2 and 4).
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately:
- if you get symptoms of an allergic reaction (see below)
- if you notice that the medicine is not working properly
The following side effects have been observed with factor IX drugs:
- Hypersensitivity s the allergic are possible (less common) and may include these symptoms: hives, skin rash (generalized urticaria ), chest tightness, wheezing, low blood pressure and anaphylaxis (a severe allergic reaction that causes breathing difficulties, dizziness). Stop using the medicine and contact a doctor immediately if you get any such symptoms.
- Inhibitors: the drug stops working properly (continued bleeding). You can develop an inhibitor (neutralizing antibody ) to factor IX (occurs in an unknown number of users), which means that factor IX no longer works properly. If this happens, stop using the medicine immediately and contact your doctor.
The following side effects have been observed commonly with IDELVION (may affect up to 1 in 10 people):
- Headache
- Injection site reactions
- Dizziness
The following side effects have been reported uncommonly (may affect up to 1 in 100 people):
- Rash
- Eczema
Side effects are in children and adolescents
Side effects in children are expected to be the same as in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store IDELVION
- 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 label and carton.
- Do not store above 25 ° C.
- Do not freeze.
- Keep the vial in the outer carton. Sensitive to light.
- The finished product should preferably be used immediately.
If the reconstituted product is not administered immediately, the storage time and conditions before use are the responsibility of the user.
6. Contents of the packaging and other information
Content declaration
The active substance is:
250 IU per vial: after reconstitution with 2.5 ml of water for injections, the solution contains 100 IU / ml albutrepenone and alfa.
500 IU per vial: after reconstitution with 2.5 ml of water for injections, the solution contains 200 IU / ml albutrepenone and alfa.
1000 IU per vial: after reconstitution with 2.5 ml of water for injections, the solution contains 400 IU / ml albutrepenone and alfa.
2000 IU per vial: after reconstitution with 5 ml of water for injections, the solution contains 400 IU / ml albutrepenone and alfa.
3500 IU per vial: after reconstitution with 5 ml of water for injections, the solution contains 700 IU / ml albutrepenone and alfa.
Other ingredients are:
Sodium citrate, polysorbate 80, mannitol, sucrose, and hydrochloric acid (for pH adjustment)
See the last paragraph in section 2.
Diluent: Water for injections
What the medicine looks like and contents of the pack
IDELVION is a light yellow to white powder and is supplied with water for injections as diluent.
The reconstituted solution should be clear or slightly opalescent, yellow to colorless, ie it may glisten if held against the light, but it must not contain any visible particles.
Packaging designs:
A pack of 250, 500, or 1000 IU contains:
1 vial of powder
1 vial with 2.5 ml of water for injections
1 transfer set with filter 20/20
The inner carton contains:
1 5 ml disposable syringe
1 venipuncture set
2 alcohol dryers
1 non-sterile patch
A pack of 2000 IU or 3500 IU contains:
1 vial of powder
1 vial with 5 ml water for injections
1 transfer set with filter 20/20
The inner carton contains:
1 10 ml disposable syringe
1 venipuncture set
2 alcohol dryers
1 non-sterile patch
Marketing Authorization Holder and Manufacturer
CSL Behring GmbH
Emil-von-Behring-Straße 76
35041 Marburg
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienCSL Behring NV Tel: +32 15 28 89 20 | LithuaniaCSL Behring GmbHTel: +4 9 69 30584437 |
| BulgariaThis is the FARM BULGARIA LADTel: +359 2 810 3949 | Luxembourg / LuxemburgCSL Behring NVTel: +32 15 28 89 20 |
| Czech RepublicCSL Behring sroTel: + 420 702 137 233 | HungaryCSL Behring Kft.Tel .: +36 1 213 4290 |
| DenmarkCSL Behring ABTel: +46 8 544 966 70 | MaltaAM Mangion Ltd.Tel: +356 2397 6333 |
| GermanyCSL Behring GmbHTel: +49 69 30584437 | The NetherlandsCSL Behring BVTel: + 31 85 111 96 00 |
| EestiCSL Behring GmbHTel: +4 9 69 30584437 | NorwayCSL Behring ABTel: +46 8 544 966 70 |
| GreeceCSL Behring ΕΠΕ:Ηλ: +30 210 7255 660 | AustriaCSL Behring GmbHTel: +43 1 80101 2463 |
| SpainCSL Behring SATel: +34 933 67 1870 | PolandCSL Behring Sp.z ooTel: +48 22 213 22 65 |
| CroatiaMarti Farm doo Tel: +385 1 5588297 | RomaniaPrisum International Trading srlTel: +40 21 322 0171 |
| IrelandCSL Behring UK Ltd.Tel: +44 1444 447405 | SloveniaMediSanus dooTel: +386 1 25 71 496 |
| IcelandCSL Behring ABPhone: +46 8 544 966 70 | Slovak RepublicCSL Behring sroTel: + 421 911 653 862 |
| ItalyCSL Behring SpATel: +39 02 34964 200 | Finland / FinlandCSL Behring ABPuh / Tel: +46 8 544 966 70 |
| ΚύπροςCSL Behring ΕΠΕ:Ηλ: +30 210 7255 660 | SwedenCSL Behring ABTel: +46 8 544 966 70 |
| LatviaCSL Behring GmbHTel: +49 69 30584437 | United KingdomCSL Behring UK Ltd.Tel: +44 1444 447405 |