Finding a treatment that works for you is important
From prophylaxis in adults and children (0-16 years), to helping to stop bleeds in adults and children on demand, you need a hemophilia A treatment that works for you. Click on the table below to learn more about the efficacy of Kogenate® FS Antihemophilic Factor (Recombinant).
15.2x Fewer Bleeds with Prophylaxis1
In a clinical study measuring the results of Kogenate® FS as on-demand treatment versus prophylaxis (regular use) in previously treated adults, routine prophylactic treatment was proven to reduce the frequency of bleeds regardless of age, presence or absence of target joints, and bleeding history.1
Average number of total bleeds per person per year1,2(P<0.0001)
On-demand (n=42)
Prophylaxis (n=42)
With prophylaxis 94% Reduction in average number of bleeds per year
Adult prophylaxis study design1,2:
- 84 previously treated males with severe hemophilia A
- Aged 15 to 50 years
- People received Kogenate FS either 3 times/week or on demand after a bleed
- Primary endpoint was bleeding frequency
- Bleeding frequency was analyzed after a median follow-up period of 1.4 years
Median annual bleed rate (ABR)1,2(P<0.0001)
On-demand (n=42)
33
Bleeds per year
Range: 0-104.1
Prophylaxis (n=42)
0
Bleeds per year*
Range: 0-19.8
Median=The middle value of a set of numbers placed in numerical order
Selected safety information
- You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS.
- Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.
Your treatment for controlling joint bleeds
Average number of joint bleeds per year1,2
On-demand (n=42)
29
Joint bleeds
per year
Prophylaxis (n=42)
2
Joint bleeds
per year
Median number of joint bleeds per year1,3
On-demand (n=42)
24
Joint bleeds
per year
Range: 0-80.1
Prophylaxis (n=42)
0
Joint bleeds
per year*
Range: 0-18.4
Median=The middle value of a set of numbers placed in numerical order
Eight times fewer bleeds
Children using Kogenate FS as a prophylaxis treatment saw eight times fewer joint bleeds per year compared with enhanced on-demand treatment.1,4
Over 8x fewer joint bleeds per patient per year1
The average rate of index joint bleeds for subjects on on-demand therapy was 4.89 bleeds per year, versus 0.63 bleeds per year in the prophylaxis group.
Study description:
A total of 65 boys <30 months of age with severe hemophilia A (FVIII level ≤2 IU/dL) with ≤2 bleeds into each index joint and normal baseline joint imaging were observed for up to 5.5 years in a multicenter, open-label, prospective, randomized, controlled clinical study.
Patients received Kogenate FS either 25 IU/kg every other day (primary prophylaxis, n=32) or at least 3 doses totaling a minimum of 80 IU/kg at the time of a bleeding episode (enhanced episodic, n=33).
Joint damage was evaluated by MRI or radiography, and the frequency of bleeding episodes was assessed.
Safety in routine prophylaxis
- Overall, 12.5% (8 of 64) of study patients developed any level of inhibitors over the 5.5-year study.1
- Two patients developed high-titer inhibitors and were withdrawn from the study.1,4
- Previously Untreated Patients Inhibitor Registry Data
Post marketing registries in previously untreated patients taking Kogenate FS have shown inhibitor development rates of 31-50% which is comparable to previously-reported inhibitor rates for FVIII products. Some of these registries showed a trend towards an increased risk of inhibitor development in PUPs taking Kogenate FS, as compared to another rFVIII product.1 - There were no life-threatening bleeds* in routine prophylaxis group (0 of 32 patients) compared with approximately 10% (3 of 33) in the episodic group. 1,4
- Most adverse events were associated with central venous access, and there were no statistically significant differences between the two study groups. 1,4
A life-threatening bleed is a major hemorrhage or loss of blood, such as an intracranial or gastrointestinal bleed, which may result in death.
Proven results
Joint health is important for children living with hemophilia A. In one clinical study, 93% (25 of 27) of children with no pre-existing joint damage who were treated with Kogenate® or Kogenate® FS for routine prophylaxis up to 5.5 years had no joint damage as measured by magnetic resonance imaging (MRI), compared with 55% (16 of 29) of children given on-demand treatment with Kogenate or Kogenate FS.1,4
The difference between the 2 groups was statistically significant when using MRI but not when using x-ray alone.1
9 out of 10
children on routine prophylaxis experienced no joint damage, as measured by MRI.4
Joint Outcome Study (JOS) study description: A total of 65 boys aged 0 to 2.5 years at the beginning of the study, with severe hemophilia A (FVIII level ≤2 IU/dL) and with ≤2 bleeds into each index joint and normal baseline joint imaging were observed for up to 5.5 years in a multicenter, open-label, prospective, randomized, controlled clinical study. Patients received either 25 IU/kg every other day (routine prophylaxis; 32 people) or at least 3 doses totaling a minimum of 80 IU/kg at the time of a bleeding episode (enhanced episodic; 33 people). Joint damage was evaluated by MRI or radiography, and the frequency of bleeding episodes was assessed.1,4
Selected Safety Information
- You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS.
- Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.
- You could have an allergic reaction to Kogenate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure.
Safety in routine prophylaxis
- Overall, 12.5% (8 of 64) of study patients developed any level of inhibitors over the 5.5-year study.1
- Two patients developed high-titer inhibitors and were withdrawn from the study.1,4
- Previously Untreated Patients Inhibitor Registry Data
Post marketing registries in previously untreated patients taking Kogenate FS have shown inhibitor development rates of 31-50% which is comparable to previously-reported inhibitor rates for FVIII products. Some of these registries showed a trend towards an increased risk of inhibitor development in PUPs taking Kogenate FS, as compared to another rFVIII product.1 - There were no life-threatening bleeds* in routine prophylaxis group (0 of 32 patients) compared with approximately 10% (3 of 33) in the episodic group. 1,4
- Most adverse events were associated with central venous access, and there were no statistically significant differences between the two study groups. 1,4
A life-threatening bleed is a major hemorrhage or loss of blood, such as an intracranial or gastrointestinal bleed, which may result in death.
Inhibitor rates
Your body can make antibodies, called “inhibitors,” against factor VIII products including Kogenate FS, which may stop factor VIII from working properly. The inhibitor rates for Kogenate FS have been measured in several studies.
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Your treatment for the adventures ahead.
Get support. Be connected.
Our support program is designed to connect you to people, resources, and personalized information related to hemophilia A.
Your treatment for the adventures ahead.
Indications
Kogenate® FS Antihemophilic Factor (Recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
Kogenate FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Kogenate FS when you have surgery. Kogenate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). Kogenate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly.
Kogenate FS is not used to treat von Willebrand disease.
Important Safety Information
You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS.
Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.
You could have an allergic reaction to Kogenate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure.
Your body can make antibodies, called “inhibitors,” against Kogenate FS, which may stop Kogenate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
Other common side effects of Kogenate FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away.
Call your healthcare provider right away if bleeding is not controlled after using Kogenate FS.
For important risk and use information, please see full prescribing information.
1. Kogenate FS with Vial Adapter [package insert]. Whippany, NJ: Bayer LLC; 2016.
2. Manco-Johnson MJ, Kempton CL, Reding MT, et al. Randomized, controlled, parallel-group trial of routine prophylaxis vs. on-demand treatment with sucrose-formulated recombinant factor VIII in adults with severe hemophilia A (SPINART). [published corrigendum appears in J Thromb Haemost. 2014;12(1):119-122]. J Thromb Haemost. 2013;11(6):1119-1127.
3. Data on file. Bayer LLC; 2014.
4. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544.
