Kogenate Bayer
octocog alfa
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
- 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 KOGENATE Bayer is and what it is used for
What you need to know before you use KOGENATE Bayer
How to use KOGENATE Bayer
Possible side effects
How to store KOGENATE Bayer
Contents of the pack and other information
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.
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.
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.
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.
The listed warnings and precautions apply to patients of all ages, adults and children.
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.
No effects on ability to drive or use machines have been observed.
This medicinal product contains less than 1 mmol (23 mg) sodium per vial and is therefore considered essentially “sodium-free”.
It is recommended that every time that you use KOGENATE Bayer, the name and batch number of the product are documented.
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.
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.
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.
Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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.
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.
rash/itchy rash
local reactions where you injected the medication (e.g. burning sensation, temporary redness)
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
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.
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.
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.
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
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.
Bayer AG
51368 Leverkusen Germany
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.
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Байер България ЕООД Tел.: 359 02 81 401 01
Bayer s.r.o.
Tel: +420 266 101 111
Bayer A/S
Tlf: +45 45 23 50 00
Bayer Vital GmbH
Tel: +49 (0)214-30 513 48
Bayer OÜ
Tel: +372 655 8565
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30-210-61 87 500
Bayer Hispania S.L. Tel: +34-93-495 65 00
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54
Bayer d.o.o.
Tel: +385-(0)1-6599 900
Bayer Limited
Tel: +353 1 2999313
Icepharma hf.
Sími: +354 540 8000
Bayer S.p.A.
Tel: +39 02 397 81
NOVAGEM Limited Tηλ: +357 22 48 38 58
SIA Bayer
Tel: +371 67 84 55 63
UAB Bayer
Tel. +37 05 23 36 868
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Alfred Gera and Sons Ltd. Tel: +35 621 44 62 05
Bayer B.V.
Tel: +31-(0)297-28 06 66
Bayer AS
Tlf: +47 23 13 05 00
Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0
Bayer Sp. z o.o.
Tel: +48 22 572 35 00
Bayer Portugal, Lda. Tel: +351 21 416 42 00
SC Bayer SRL
Tel: +40 21 529 59 00
Bayer d. o. o.
Tel: +386 (0)1 58 14 400
Bayer spol. s r.o.
Tel. +421 2 59 21 31 11
Bayer Oy
Puh/Tel: +358- 20 785 21
Bayer AB
Tel: +46 (0) 8 580 223 00
Bayer plc
Tel: +44-(0)118 206 3000
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Wash your hands thoroughly using soap and warm water. The solution must be prepared on a clean and dry surface.
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).
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).
Gently screw the syringe on to the powder vial (B).
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).
Connect the plunger rod to the syringe by screwing it into the rubber stopper (E).
Inject the solvent into the vial containing the powder by slowly pushing the syringe plunger down (F).
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.
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.
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. |