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AstraZeneca

Kogenate Bayer
octocog alfa

Package Leaflet: Information for the user


KOGENATE Bayer 250 IU powder and solvent for solution for injection KOGENATE Bayer 500 IU powder and solvent for solution for injection KOGENATE Bayer 1000 IU powder and solvent for solution for injection KOGENATE Bayer 2000 IU powder and solvent for solution for injection KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)


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

- 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


What is in this leaflet

  1. What KOGENATE Bayer is and what it is used for

  2. What you need to know before you use KOGENATE Bayer

  3. How to use KOGENATE Bayer

  4. Possible side effects

  5. How to store KOGENATE Bayer

  6. Contents of the pack and other information


  1. What KOGENATE Bayer is and what it is used for


    KOGENATE Bayer contains the active substance human recombinant coagulation factor VIII (octocog alfa).


    KOGENATE Bayer is used for treatment and prophylaxis of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).

    This preparation does not contain von Willebrand factor and is therefore not to be used in von Willebrand's disease.


  2. What you need to know before you use KOGENATE Bayer Do not use KOGENATE Bayer

    • if you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).

    • if you are allergic to mouse or hamster protein. If you are unsure about this, ask your doctor.


      Warnings and precautions

      Take special care with KOGENATE Bayer and talk to your doctor or pharmacist if:

    • you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a so- called anaphylactic reaction) to this medicine. If this occurs, stop administering the product immediately and seek medical advice.

    • your bleeding is not being controlled with your usual dose of this medicine. The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If your or your child’s bleeding is not being controlled with KOGENATE Bayer, tell your doctor immediately.

    • you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.

      • you have been told you have heart disease or are at risk for heart disease.

    • you require a central venous access device (CVAD) for the administration of KOGENATE Bayer. You may be at risk of CVAD-related 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.


      Your doctor may carry out tests to ensure that your current dose of this medicine provides adequate factor VIII levels.


      Other medicines and KOGENATE Bayer

      Interactions with other medicines are not known. However, please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


      Children and adolescents

      The listed warnings and precautions apply to patients of all ages, adults and children.


      Pregnancy, breast-feeding and fertility

      Experience regarding fertility or the use of KOGENATE Bayer during pregnancy and breast-feeding is not available. Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

      KOGENATE Bayer is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.


      Driving and using machines

      No effects on ability to drive or use machines have been observed.


      KOGENATE Bayer contains sodium

      This medicinal product contains less than 1 mmol (23 mg) sodium per vial and is therefore considered essentially “sodium-free”.


      Documentation

      It is recommended that every time that you use KOGENATE Bayer, the name and batch number of the product are documented.


  3. How to use KOGENATE Bayer


    Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.

    Treatment of bleeding

    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. The doctor should always adjust the dose and the frequency of administration according to your individual needs. How much KOGENATE Bayer 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

    • the factor VIII level that is needed.


      Prevention of bleeding

      If you are using KOGENATE Bayer 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.


      Laboratory tests

      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.


      Use in children and adolescents

      KOGENATE Bayer can be used in children of all ages.


      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 A. 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.


      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 KOGENATE Bayer is a life-time treatment.


      How KOGENATE Bayer is given


      This medicine is intended for injection into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution.


      How KOGENATE Bayer is prepared for administration

      Use only the items (powder vial with Bio-Set cap, pre-filled syringe containing solvent and venipuncture set) 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 any possible particles in the solution. You are filtering by following the reconstitution and/or administration steps as described below. Use the venipuncture set provided as it contains an in-line filter. If you cannot use the venipuncture set provided, use a separate filter as your nurse or doctor has instructed.


      Do not use the venipuncture set provided for drawing blood because it contains an in-line filter. When you must withdraw blood before an infusion, use an administration set without a filter, then infuse this medicine through an injection filter. If you have any questions about this medicine and compatible separate filters, contact your doctor.


      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 detailed instructions for reconstitution and administration provided at the end of this leaflet.


      If you use more KOGENATE Bayer than you should

      No cases of overdose with recombinant coagulation factor VIII have been reported.

      If you have used more KOGENATE Bayer than you should, please inform your doctor.


      If you forget to use KOGENATE Bayer

      • 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 KOGENATE Bayer

        Do not stop using KOGENATE Bayer 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.


    The most serious side effects are hypersensitivity reactions or anaphylactic shock (rare side effect). If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately.

    Please consult your doctor immediately.


    For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). If this happens your or your child’s medicines may stop working properly and you or your

    child may experience persistent bleeding. If this happens, you should contact your doctor immediately.


    Other possible side effects:


    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 (which may include hives, nausea, urticaria, angioedema, chills, flushing, headache, lethargy, wheezing or difficulty breathing, restlessness, tachycardia, tingling or 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)

    • fever


      Not known (frequency cannot be estimated from the available data):

    • dysgeusia (strange taste)


      If you notice any of the following symptoms during injection/infusion:

    • chest tightness/general feeling of being unwell

    • dizziness

    • mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)

    • nausea

    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.


    Hypersensitivity reactions

    During clinical studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. 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.


    Reporting of side effects

    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.


  5. How to store KOGENATE Bayer


    Keep this medicine out of the sight and reach of children.


    Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.


    Within the expiry date indicated on the label, this medicine when kept in its outer carton may be stored at ambient room temperature (up to 25°C) for a limited period of 12 months. In this case, this medicine expires at the end of this 12-month period or the expiration date on the product vial, whichever is earlier. The new expiry date must be noted on the outer carton.


    Do not refrigerate the solution after reconstitution. The reconstituted solution must be used within 3 hours. This product is for single use only. Any unused solution must be discarded.


    Do not use this medicine after the expiry date which is stated on labels and cartons. The expiry date refers to the last day of that month.


    Do not use this medicine if you notice any particles or the solution is cloudy.


    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  6. Contents of the pack and other information What KOGENATE Bayer contains

Powder

The active substance is human coagulation factor VIII (octocog alfa) produced by recombinant DNA technology. Each vial of KOGENATE Bayer contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.

The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose (see end of section 2).


Solvent

Water for injections


What KOGENATE Bayer looks like and content of the pack


KOGENATE Bayer is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake. The pre-filled syringe contains water for injections to be used to reconstitute the contents of the vial. After reconstitution the solution is clear. Medical devices for reconstitution and administration are provided with each package of this medicine.


Each pack of KOGENATE Bayer contains a vial with Bio-Set transfer system and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.


Marketing Authorisation Holder

Bayer AG

51368 Leverkusen Germany


Manufacturer

Bayer HealthCare Manufacturing S.r.l. Via delle Groane 126

20024 Garbagnate Milanese (MI)

Italy

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


België/Belgique/Belgien

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

България

Байер България ЕООД Tел.: 359 02 81 401 01

Česká republika

Bayer s.r.o.

Tel: +420 266 101 111

Danmark

Bayer A/S

Tlf: +45 45 23 50 00

Deutschland

Bayer Vital GmbH

Tel: +49 (0)214-30 513 48

Eesti

Bayer OÜ

Tel: +372 655 8565

Ελλάδα

Bayer Ελλάς ΑΒΕΕ

Τηλ: +30-210-61 87 500

España

Bayer Hispania S.L. Tel: +34-93-495 65 00

France

Bayer HealthCare

Tél (N° vert): +33-(0)800 87 54 54

Hrvatska

Bayer d.o.o.

Tel: +385-(0)1-6599 900

Ireland

Bayer Limited

Tel: +353 1 2999313

Ísland

Icepharma hf.

Sími: +354 540 8000

Italia

Bayer S.p.A.

Tel: +39 02 397 81

Κύπρος

NOVAGEM Limited Tηλ: +357 22 48 38 58

Latvija

SIA Bayer

Tel: +371 67 84 55 63

Lietuva

UAB Bayer

Tel. +37 05 23 36 868

Luxembourg/Luxemburg

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Magyarország Bayer Hungária KFT Tel:+36 14 87-41 00

Malta

Alfred Gera and Sons Ltd. Tel: +35 621 44 62 05

Nederland

Bayer B.V.

Tel: +31-(0)297-28 06 66

Norge

Bayer AS

Tlf: +47 23 13 05 00

Österreich

Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0

Polska

Bayer Sp. z o.o.

Tel: +48 22 572 35 00

Portugal

Bayer Portugal, Lda. Tel: +351 21 416 42 00

România

SC Bayer SRL

Tel: +40 21 529 59 00

Slovenija

Bayer d. o. o.

Tel: +386 (0)1 58 14 400

Slovenská republika

Bayer spol. s r.o.

Tel. +421 2 59 21 31 11

Suomi/Finland

Bayer Oy

Puh/Tel: +358- 20 785 21

Sverige

Bayer AB

Tel: +46 (0) 8 580 223 00

United Kingdom

Bayer plc

Tel: +44-(0)118 206 3000


This leaflet was last revised in {MM/YYYY}


Detailed information on this medicinal product is available on the website of the European Medicines Agency

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Detailed instructions for reconstitution and administration of KOGENATE Bayer using vial with reconstitution cap (Bio-Set System):


image

  1. Wash your hands thoroughly using soap and warm water. The solution must be prepared on a clean and dry surface.


  2. Warm the unopened powder vial and the solvent syringe in your hands until they feel as warm as your hands. The material should not be warmer than body temperature (not exceed 37 °C).


  3. Remove the cap from the powder vial by gently moving it from side to side several times, whilst at the same time pulling upwards. Remove the stopper attached to the white cap from the syringe (A).


  4. Gently screw the syringe on to the powder vial (B).



  5. Place the vial on a rigid, non-slip surface and hold it firmly with one hand. Then, strongly press down the fingerplate near the syringe tip using your thumb and index finger (C) until the finger plate meets the top edge of the reconstitution cap (Bio-Set).


    This indicates that the system is activated (D).



  6. Connect the plunger rod to the syringe by screwing it into the rubber stopper (E).



  7. Inject the solvent into the vial containing the powder by slowly pushing the syringe plunger down (F).



  8. Dissolve the powder by gently swirling the vial (G). Do not shake the vial! Ensure that the powder is completely dissolved before use. Inspect visually for particulate matter and discoloration prior to administration. Do not use solutions that contain visible particles or that are cloudy.


  9. Invert vial/syringe and transfer the solution into syringe by drawing the plunger out slowly and smoothly (H). Ensure that the entire contents of the vial are drawn into the syringe. Hold the syringe upright and push the plunger until no air is left in the syringe.

image


10. Apply a tourniquet. Determine the point of injection, clean the skin with an alcohol swab, and prepare site of injection antiseptically as advised by your doctor. Puncture the vein and secure the venipuncture set with a plaster.

11. Unscrew the syringe to disconnect the vial (I).

12. Attach the syringe to the venipuncture set by screwing it clockwise and ensure that no blood enters the syringe (J).

13. Remove tourniquet!

14. Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle. The speed of administration should be based on your comfort, but should not be faster than

2 mL per minute.

15. If a further dose is required, remove the empty syringe by turning it anti-clockwise. Reconstitute the desired amount of product, repeating steps 2 – 9, using a new syringe and connect it to the venipuncture set.

16. If no further dose is required, remove the venipuncture set and syringe. Hold a pad firmly over the injection site on your outstretched arm for approximately 2 minutes. Finally, apply a small pressure dressing to the injection site and consider if a plaster is necessary.