3. How to use Helixate NexGen 500 IU
- Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
- This medicine is intended for intravenous administration only and must be administered immediately after reconstitution.
- You must use aseptic conditions (meaning clean and germ free) during reconstitution and administration. Use only the medical devices for reconstitution and administration that are provided with each package of this medicine. If these components cannot be used, please contact your doctor. If any component of the package is opened or damaged, do not use it.
- You must filter the reconstituted product before administration to remove potential particulate matter in the solution. Filtering is achieved by using the Mix2vial adapter.
- This medicine must not be mixed with other infusion solutions. Do not use solutions containing visible particles or that are cloudy. Follow the directions given by your doctor closely and use the instructions below as a guide:
Reconstitution and administration
1. Wash your hands thoroughly using soap and warm water.
2. Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).
3. Ensure product and solvent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry prior to opening the Mix2Vial package.
4. Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package!
5. 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.
6. 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.
7. Place the product 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.
8. With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully into two pieces. Discard the solvent vial with the blue Mix2Vial adapter attached.
9. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake. Inspect visually for particulate matter and discolouration prior to administration. Do not use solutions containing visible particles or that are cloudy.
10. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting. Inject air into the product vial.
11. While keeping the syringe plunger pressed, invert the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
12. 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. Hold the syringe upright and push the plunger until no air is left in the syringe.
13. Apply a tourniquet.
14. Determine the point of injection and prepare antiseptically.
15. Puncture the vein and secure the venipuncture set with a plaster.
16 Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution. Make sure that no blood enters the syringe.
17. Remove tourniquet.
18. Inject the solution intravenously over several minutes, keeping an eye on the position of the needle. The speed of administration should be based on the patient’s comfort, but should not be faster than 2 ml/min maximum rate of infusion.
19. If a further dose needs to be administered, use a new syringe with product reconstituted as described above.
20. If no further dose is required, remove the venipuncture set and syringe. Hold a swab firmly over the injection site on the outstretched arm for approx. 2 minutes. Finally, apply a small pressure dressing to the wound.
Treatment of bleeding
How much Helixate NexGen 500 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed.
Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
He/she should always adjust the amount of this medicine to be administered and the frequency of administration according to your individual needs. Under certain circumstances larger amounts than those calculated may be required, especially for the initial dose.
Prevention of bleeding
If you are using Helixate NexGen to prevent bleeding (prophylaxis), your doctor will calculate the dose for you. This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, given every 2 to 3 days. However, in some cases, especially for younger patients, shorter dose intervals or higher doses may be necessary.
It is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained. For major surgery in particular, close monitoring of the substitution therapy by means of coagulation analysis
must be carried out.
If bleeding is not controlled
If the factor VIII level in your plasma fails to reach expected levels, or if bleeding is not controlled after apparently adequate dose, you may have developed factor VIII inhibitors. This must be checked by an experienced doctor.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor.
Patients with inhibitors
If you have been told by your doctor that you have developed factor VIII inhibitors you may need to use a larger amount of this medicine to control bleeding. If this dose does not control your bleeding your doctor may consider giving you an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate.
These treatments should be prescribed by doctors with experience in the care of patients with haemophilia. Speak to your doctor if you would like further information on this.
Do not increase your dose of medicine you use to control your bleeding without consulting your doctor.
Speed of administration
This medicine should be injected intravenously over several minutes. The rate of administration should be determined by the patient’s comfort level (maximal rate of infusion: 2 ml/min).
Duration of treatment
Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Usually, the substitution therapy with Helixate NexGen is a life-time treatment.
If you use more Helixate NexGen 500 IU than you should
No cases of overdose with recombinant coagulation factor VIII have been reported.
If you have used more Helixate NexGen 500 IU than you should, please inform your doctor.
If you forget to use Helixate NexGen 500 IU
- Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
Do not take a double dose to make up for a forgotten dose.
If you want to stop using Helixate NexGen 500 IU
Do not stop using Helixate NexGen without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 users
- rash/itchy rash
- local reactions where you injected the medication (e.g. burning sensation, temporary redness)
Rare: may affect up to 1 in 1,000 users
- hypersensitivity reactions, including severe sudden allergic reaction (anaphylactic shock), e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing
Very rare or unknown: may affect less than 1 in 10,000 users
If you notice any of the following symptoms during injection/infusion:
- chest tightness/general feeling of being unwell
- mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)
this can constitute an early warning for hypersensitivity and anaphylactic reactions. If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately. Please consult your doctor immediately.
The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the treatment of patients with haemophilia A. Your doctor may wish to carry out tests to monitor inhibitor development.
During clinical studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. However, the possibility of allergic reactions to substances contained in this medication, e.g. trace amounts of mouse and hamster protein exists in certain predisposed patients.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.