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Why have I been prescribed KOGENATE^® Bayer?

You have been prescribed KOGENATE^® Bayer because you have haemophilia A. This means that your body cannot produce a protein known as factor VIII (FVIII) and must get it from somewhere else. KOGENATE^® Bayer is a FVIII product that your body can use instead of natural FVIII.

What is KOGENATE^® Bayer?

KOGENATE^® Bayer is a recombinant factor VIII product (rFVIII). Recombinant factor VIII is produced by a process called genetic engineering. This involves taking a copy of the human gene that makes factor VIII and growing it under special conditions in a laboratory. The factor VIII that is produced is collected and sterilised. It is then ready for use.

Factor VIII that is made in this way is exactly the same as human factor VIII as it is derived from the human factor VIII gene.

How is KOGENATE^® Bayer supplied?

KOGENATE^® Bayer is supplied as a powder in a single-use bottle (known as a vial) with a pre-filled syringe and vial adapter for reconstitution. For added convenience alcohol swabs, a butterfly set, plasters and dry swabs are also included.

Always check the amount of KOGENATE^® Bayer printed on the label to make sure you are using the correct dose. Blue, green, yellow, black and red colour coding is used to enable easy identification of the correct dose and to avoid confusion.

To ensure greater confidence, the packaging includes anti-counterfeit measures and tamper-evident seals.

How should I store KOGENATE^® Bayer?

Before reconstitution, KOGENATE^® Bayer can be stored in the fridge between 2-8°C.

However, if it's more convenient, you can store it at room temperature (up to 25°C) for a maximum of twelve months. If you decide to remove it from the fridge, then it might be useful to store it in a cupboard or appropriate place so its temperature never exceeds 25°C. You must also make sure you change its expiry date.

For example: if you take your KOGENATE^® Bayer out of the fridge on the 14th August, and you decide to leave it out, then its new expiry date will be the 14th August, exactly twelve months to the day. Write this new expiry date on the top of the box, and store your medicine in its outer box in an appropriate place.

Whether you keep KOGENATE^® Bayer in the fridge or leave it out, you should always keep the medicine in its outer carton to protect it from light. Freezing must be avoided and do not use KOGENATE^® Bayer beyond its expiry date.

How do I manage my records?

The product expiry date
When you take KOGENATE^® Bayer out of the fridge, work out the date twelve months from that day, and write it on the top of the box in the space provided. This is the new expiry date and you must use this pack of KOGENATE^® Bayer by then or dispose of it.

Your treatment records
To make it quick and easy to keep an accurate record of infusions, the KOGENATE^® Bayer vials have peel-off labels. These labels can be transferred to your treatment diary so you can easily track the dose and batch number of each infusion.

Does KOGENATE^® Bayer have other side effects?

Most people do not experience side effects with KOGENATE^® Bayer. However, if you experience any, contact your haemophilia doctor or nurse immediately (see patient information leaflet for more information).

What is prophylaxis?

Prophylaxis means giving treatment in advance to prevent a condition from happening. In the case of haemophilia, prophylaxis involves giving regular infusions of missing factor to prevent bleeds occurring. In contrast, ‘on-demand therapy' involves giving the missing factor after a bleed has started.

What are inhibitors?

An inhibitor is an antibody that reduces the ability of a FVIII product to control bleeding.

Antibodies are part of the immune system. They recognise foreign proteins and destroy them in order to protect the body from disease. Unfortunately, antibodies occasionally perceive natural proteins as foreign, and destroy them. Some people with severe haemophilia develop antibodies against FVIII. The antibodies destroy the FVIII, reducing the efficacy of treatment.

What is the chance that I will get an inhibitor?

The formation of inhibitors to FVIII is a known complication in the management of individuals with haemophilia A. In studies with recombinant FVIII products, development of inhibitors occurs predominantly in previously untreated patients.

In a clinical trial of previously untreated patients taking KOGENATE^® Bayer, 9 out of 60 (15%)¹ developed inhibitors. In a clinical trial of previously treated patients using KOGENATE^® Bayer 0 out of 71 (0%) ²developed inhibitors. However, inhibitors may occur at any time and can make your treatment less effective. Talk to your doctor if you feel your treatment is not working as well as it did previously as this could be a sign that an inhibitor is developing.