• In PTPs
• In PUPs

• In PTPs
• In PUPs

• The manufacturing process

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What is KOGENATE^® Bayer?

KOGENATE^® Bayer is a rFVIII concentrate exclusively developed and manufactured by Bayer. Its manufacture eliminates the use of human albumin in both the purification process and the final formulation,and adds a 2nd and well-accepted viral inactivation step (solvent/detergent treatment) to the process.

How convenient is KOGENATE^® Bayer?

More convenient for you because . . .

KOGENATE^® Bayer now has a licence for continuous infusion, giving you peace of mind

• Each pack has a unique serialised barcode, to aid inventory management
• Low injection volume (2.5mL) gives a shorter infusion time, and potentially reduces the need for repeat venipuncture when infusing young children ¹⁷

More convenient for your patients because . . .

• KOGENATE^® Bayer has 12 months room temperature storage, so travelling with Factor is possible.
• Peal-off adhesive label assists patient compliance
• Small package makes it easy to transport

Is KOGENATE^® Bayer licensed for continuous infusion?

Yes. A study has confirmed that excellent haemostatic efficacy can be achieved with continuous infusion of KOGENATE^® Bayer during major surgery.

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How is KOGENATE^® Bayer manufactured?

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What steps are taken to minimise possible contamination by viruses, prions or other pathogens?

KOGENATE^® Bayer derives it's active ingredient from mammalian cell culture by recombinant technology which minimises the theoretical risk of infection.

To date there has been zero confirmed cases of viral or prion transmission in 19 years and 6 billion units infused ³*

*Combined history of Kogenate^® and KOGENATE^® Bayer

Many steps are taken to ensure the safety of KOGENATE^® Bayer including the following:

• Raw materials are continuously subject to careful scrutiny and a battery of quality-assurance tests.
• Fermentation medium is free of bovine proteins.
• No addition of human albumin during purification or as a stabiliser in final formulation
• The KOGENATE^® Bayer cell bank is developed to international safety standards
• Bayer has developed a robust purification process that involves extensive chromatography including two viral inactivation steps*, all performed at 2-8 oC to ensure the quality and purity of KOGENATE^® Bayer.
• The process has been validated to show viral and prion reduction. Click here for more details
• From fermenter to vial, each batch of KOGENATE^® Bayer undergoes at least 200 quality control tests

What were the results of the clinical studies performed on KOGENATE^® Bayer?

In PTP's

Results of home treatment

In an open label study of 71 PTP's with severe haemophilia A

• 80% of bleeds were treated effectively with a single infusion of KOGENATE^® Bayer (n=2585 bleeds) ⁵
• 93% of bleeds were treated effectively with one or two infusions of KOGENATE^® Bayer (n=2585 bleeds) ⁵

Results in Surgery

In a total of 40 surgical procedures on 30 PTP's with haemophilia A, haemostasis was rated as either excellent or good for all procedures and was accompanied by minimal blood loss (Data on file, KGB02).

The procedures performed in this clinical trial included minor and major procedures and are considered representative of the demands for a FVIII concentrate in clinical practice (Seremetis et al,1999;Scharrer et al,2000).

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In PUPs

In previously untreated patients (PUPs) aged ≤ 4 years with severe haemophilia A, 89% of all treated bleeding episodes were successfully treated with one (74%) or two (15%) infusions of KOGENATE^® Bayer (n=1178 bleeds) ¹

Is KOGENATE^® Bayer safe and well tolerated?

Previously Treated Patients (PTPs)

71 PTP's who completed up to 54 months of home treatment were observed for tolerability and safety following a single infusion.

The KOGENATE^® Bayer safety report confirms that this rFVIII preparation is well tolerated and has a good safety profile for the treatment of patients with haemophilia A (Data on file, KGB02) (Abshire et al 2000; Larson et al, 2004)

* Other than those attributed to vaccination

Previously Untreated Patients/Minimally Treated Patients (PUPs/MTPs)

The treatment of 61 PUPs/MTPs provides evidence for good tolerability in children. (Kreutz et al, 2005)

* Other than those attributed to vaccination

Have there been any problems with inhibitor formation?

Previously Treated Patients (PTPs)

In a clinical trial of previously treated patients using KOGENATE^® Bayer 0 out of 71 (0%) developed inhibitors. ¹¹

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Previously Untreated Patients/Minimally Treated Patients (PUPs/MTPs)

In clinical trials of previously untreated patients using KOGENATE^® Bayer 9 out of 60 (15%) developed inhibitors. ¹

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How many infusions of KOGENATE^® Bayer are required to stop bleeding episodes?

In PTP's

In an open-label study of 71 previously treated patients (PTPs) with severe haemophilia A:

• 80% of bleeds were treated effectively with a single infusion of KOGENATE^® Bayer (n=2585 bleeds) ⁵
• 93% of bleeds were treated effectively with one or two infusions of KOGENATE^® Bayer (n=2585 bleeds) ⁵

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In PUP's

In previously untreated patients (PUPs) aged ≤ 4 years with severe haemophilia A, 89% of all treated bleeding episodes were successfully treated with one (74%) or two (15%) infusions of KOGENATE ^® Bayer (n=1178 bleeds) ¹

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What is the evidence for prophylaxis with KOGENATE^® Bayer?

The 'Joint outcome study' is a prospective, randomised, clinical trial that provides convincing evidence in support of prophylaxis with KOGENATE^® Bayer in the treatment of haemophilia. ²³

A prophylaxis regimen of alternate day infusions of 25iu/kg KOGENATE^® Bayer was compared with on-demand therapy using infusions totalling ≥ 80 iu/kg at the time of each joint haemorage. ²³

The study showed that prophylaxis patients had fewer joint bleeds per year compared to on-demand patients. ²³

It also showed an 84% reduction in the risk of joint damage in patients receiving prophylaxis from an early age. ²³

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The adult prophylaxis study was the first to show conclusive evidence of prophylaxis benefits with KOGENATE Bayer in patients with severe haemophilia A. ²⁷

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Is there any benefit of high dose prophylaxis over low dose?

The efficacy of two prophylactic regimens were compared in 128 patients with severe haemophilia. Forty-two Swedish patients (high-dose prophylaxis 25-40 IU/kg 3 times a week) were compared with 86 Dutch patients (intermediate-dose prophylaxis 15-25 IU/kg 2-3 times per week). Patients treated with high-dose prophylaxis suffered fewer joint bleeds per year (median 0.3 per year vs. 3.3 per year). ²⁵ The study concluded that high-dose prophylaxis significantly reduced joint bleeds over 3 years compared with an intermediate dose regimen. ²⁵

How much sucrose is in one vial of KOGENATE^® Bayer?

Every vial of KOGENATE^® Bayer contains 28mg of sucrose. Sucrose is a disaccharide, a molecule composed of one glucose and one fructose sugar unit. When administered intravenously, it is not broken down by enzymes in the blood, and therefore not converted into glucose. Due to the kinetics of sucrose excretion following intravenous infusion, accumulation of the stabiliser is unlikely to occur. In addition, the amount of sucrose infused with high doses of KOGENATE^® Bayer, such as those administered in immune tolerance induction (ITI), are at least 1000 times lower than the amounts reported to be possibly related to hyperosmolar renal damage with products such as intravenous immunoglobulin G (IgG) ²⁶

Can KOGENATE^® Bayer be kept out of the fridge?

KOGENATE^® Bayer can now be stored at room temperature for up to 12 months.

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

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 tamper proof is the packaging?

Bayer has introduced tamper-evident packaging for KOGENATE^® Bayer. A clear, round label with the Bayer cross that folds over the opening of each box forms a seal. If the seal is broken prior to use, the pack should not be used.