IDELVION 500 IU powder and solvent for solution for injection

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have 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.

What is in this leaflet:

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

What is IDELVION?

IDELVION is a haemophilia medicine that replaces a natural blood clotting (coagulation) factor IX. The active substance in IDELVION is albutrepenonacog alfa (recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)).

Factor IX is involved in blood clotting. Patients with haemophilia B have a lack of this factor which means that their blood does not clot as quickly as it should so there is an increased tendency to bleed. IDELVION works by replacing factor IX in haemophilia B patients to enable their blood to clot.

What is IDELVION used for?

IDELVION is used to prevent or to halt bleeding caused by the lack of factor IX in patients of all age groups with haemophilia B (also called congenital factor IX deficiency or Christmas disease).

Do not use IDELVION

• If you are allergic to the active ingredient (albutrepenonacog alfa) or any of the other ingredients (listed in section 6).
• If you are allergic to hamster proteins.

Warnings and precautions

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

• Allergic (hypersensitivity) reactions are possible. The product contains traces of hamster proteins (see also “Do not use IDELVION”). If symptoms of allergic reactions occur, you should stop using the medicine immediately and contact your doctor. Your doctor should inform you of the early signs of hypersensitivity reactions. These include hives, generalised skin rash, tightness of the chest, wheezing, low blood pressure (hypotension), and anaphylaxis (a serious allergic reaction that causes severe difficulty in breathing, or dizziness).
• Because of the risk of allergic reactions with factor IX, your initial administration of IDELVION should be performed under medical observation where proper medical care for allergic reactions can be provided.
• The formation of inhibitors (neutralising antibodies) is a known complication that can occur during treatment, which stops the treatment working properly. If your bleeding is not being controlled with IDELVION, tell your doctor immediately. You should be monitored carefully for the development of inhibitors.
• If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications.
• If you need a central venous access device (CVAD for injection of IDELVION), the risk of complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.

Record of use

It is strongly recommended that every time IDELVION is given, the date of administration, the batch number and the injected volume is recorded in the treatment diary.

Other medicines and IDELVION

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

• 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 breast-feeding, IDELVION should be given only if it is clearly needed.

Driving and using machines

IDELVION does not affect your ability to drive and use machines.

IDELVION contains sodium

IDELVION contains up to 25.8 mg (1.13 mmol) sodium per dose (bodyweight 70 kg) if the maximal dose (15 ml = 6000 IU) is applied. Please take this into account if you are on a controlled sodium diet.

Dose

Your doctor will calculate the dose of IDELVION you need.

The amount of IDELVION you need to take and the duration of treatment depend on:

• the severity of your disease
• the site and intensity of the bleeding
• your clinical condition and response
• your body weight

Follow the directions given to you by your doctor.

If you use more IDELVION than you should

Please contact your doctor immediately if you inject more IDELVION than your doctor recommends.

If you stop using IDELVION

Do not stop using IDELVION without consulting your doctor.

Reconstitution and application

General Instructions

• The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions.
• IDELVION must not be mixed with other medicines or solvents except those mentioned in section 6.
• The solution should be clear or slightly opalescent, yellow to colourless, i.e. it might be sparkling when held up to the light but must not contain any obvious particles. After filtering or withdrawal (see below) the solution should be checked by eye, before it is used. Do not use the solution if it is cloudy or if it contains flakes or particles.
• Any unused product or waste material should be disposed of in accordance with local requirements and as instructed by your doctor.

Reconstitution

Without opening the vials, warm the IDELVION powder and the liquid to room or body temperature. This can be done either by leaving the vials 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 °C).

Carefully remove the protective caps from the vials, and clean the exposed rubber stoppers with an alcohol swab. Allow the vials to dry before opening the Mix2Vial package (which contains the filter transfer device), then follow the instructions given below.

1. Open the Mix2Vial by peeling off the lid. Do not remove the Mix2Vial from the blister package!

2. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.

3. Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial set.

4. Place the powder vial on an even and firm surface. Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper. The solvent will automatically flow into the product vial.

5. With one hand grasp the powder-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully counterclockwise into two pieces.

Discard the solvent vial with the blue Mix2Vial adapter attached.

6. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.

7. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise. Inject air into the product vial.

Withdrawal and Application

8. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.

9. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise.

Use the venipuncture kit supplied with the product, insert the needle into a vein. Let blood flow back to the end of the tube. Attach the syringe to the threaded, locking end of the venipuncture kit.

Inject the reconstituted solution slowly (as comfortable for you, up to a maximum of 5 ml/min) into the vein following the instructions given to you by your doctor. Take care not to get any blood in the syringe containing the product.

Check yourself for any side effects that might happen straight away. If you have any side effects that might be related to the administration of IDELVION, the injection should be stopped (see also sections 2 and 4).

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Please contact your doctor immediately:

• if you notice symptoms of allergic reactions (see below)
• if you notice that the medicine stops working properly

The following side effects have been observed with factor IX medicines:

• Allergic-type hypersensitivity reactions are possible and may include the following symptoms: hives, skin rashes (generalised urticaria), tightness of the chest, wheezing, low blood pressure (hypotension) and anaphylaxis (a serious reaction that causes severe difficulty in breathing or dizziness). If this happens, you should stop using the medicine immediately and contact your doctor.
• Inhibitors: the medicine stops working properly (continuous bleeding). You may develop an inhibitor (neutralising antibody) to factor IX, in which case factor IX will not work properly any more. If this happens, you should stop using the medicine immediately and contact your doctor.

The following side effects have been observed with IDELVION commonly (may affect up to 1 in 10 people):

• Headache
• Injection site reactions

The following side effects occurred uncommonly (may affect up to 1 in 100 people):

• Dizziness
• Allergic reactions (Hypersensitivity)
• Rash
• Eczema

• Side effects 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 includes any possible side effects not listed in this leaflet. You can also report side effects directly – please see details below.

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

UK:

Malta:

Ireland:

What IDELVION contains

The active substance is:

250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of albutrepenonacog alfa.

500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of albutrepenonacog alfa.

1000 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.

2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.

The other ingredients are:

Tri-sodium citrate dihydrate, polysorbate 80, mannitol, sucrose, and HCl (for pH adjustment)

See last paragraph of section 2.

Solvent: Water for injections

What IDELVION looks like and contents of the pack

IDELVION is presented as a pale yellow to white powder and is supplied with water for injections as solvent.

The reconstituted solution should be clear to slightly opalescent, yellow to colourless i.e. it might sparkle when held up to the light but must not contain any obvious particles.

Presentation

One pack with 250, 500 or 1000 IU containing:

1 vial with powder

1 vial with 2.5 ml water for injections

1 filter transfer device 20/20

One inner box containing:

1 disposable 5 ml syringe

1 venipuncture set

2 alcohol swabs

1 non-sterile plaster

One pack with 2000 IU containing:

1 vial with powder

1 vial with 5 ml water for injections

1 filter transfer device 20/20

One inner box containing:

1 disposable 10 ml syringe

1 venipuncture set

2 alcohol swabs

1 non-sterile plaster

Marketing Authorization Holder and Manufacturer

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: