Kogenate FS

What is Kogenate FS?

Kogenate FS is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.

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 when used regularly (prophylaxis). Kogenate FS can reduce the risk of joint damage in children.

Kogenate FS is not used to treat von Willebrand Disease.

Description

Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS.

The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10).

Kogenate FS is formulated with the following as stabilizers  in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels.

TABLE 7 lists the inactive ingredients/excipients also contained in the final product.

 Mechanism of Action

Kogenate FS temporarily replaces the missing clotting factor VIII that is needed for effective hemostasis.

Who should not use Kogenate FS?

You should not use Kogenate FS if you

• are allergic to rodents (like mice and hamsters).
• are allergic to any ingredients in Kogenate FS.

What should I tell my healthcare provider before using Kogenate FS?

Tell your healthcare provider about all of your medical conditions.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies.

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

Tell your healthcare provider if you have been told that you have inhibitors to factor VIII (because Kogenate FS may not work for you).

Tell your healthcare provider if you are pregnant or planning to become pregnant. It is not known if Kogenate FS may harm your unborn baby.

Tell your healthcare provider if you are breastfeeding. It is not known if Kogenate FS passes into the milk.

How should I use Kogenate FS?

Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.

See the step-by-step instructions for reconstituting Kogenate FS that is provided with Kogenate FS.

You should always follow the specific instructions given by your healthcare provider. The steps listed in the information provided with Kpgenate FS are general guidelines for using Kogenate FS. If you are unsure of the procedures, please call your healthcare provider before using.

Call your healthcare provider right away if bleeding is not controlled after using Kogenate FS.

Your healthcare provider will prescribe the dose that you should take.

Your healthcare provider may need to take blood tests from time to time.

Talk to your healthcare provider before traveling. You should plan to bring enough Kogenate FS for your treatment during this time.

Carefully handle Kogenate FS. Dispose of all materials, including any leftover reconstituted Kogenate FS product, in an appropriate container.

What are the possible side effects of Kogenate FS?

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
• decrease in blood pressure

Your body can also 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)
• Infections from implanted injection device

Tell your healthcare provider about any side effect that bothers you or that does not go away.

Finding veins for injections may be difficult in young children. When frequent injections are required your child’s healthcare provider may propose to have a device surgically placed under the skin to facilitate access to the bloodstream. These devices may result in infections.

These are not all the possible side effects with Kogenate FS. You can ask your healthcare provider for information that is written for healthcare professionals.

General information about the safe and effective use of Kogenate FS

Medicines are sometimes prescribed for purposes other than those listed here. Do not use Kogenate FS for a condition for which it is not prescribed. Do not share Kogenate FS with other people, even if they have the same symptoms that you have.

This leaflet summarizes the most important information about Kogenate FS. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Kogenate FS that was written for healthcare professionals.

How should I store Kogenate FS?

Do not freeze Kogenate FS.

Store Kogenate FS at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kogenate FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F.

Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.

Reconstituted product (after mixing dry products with wet diluent) must be used within 3 hours and cannot be stored.

Throw away any unused Kogenate FS after the expiration date.

Do not use reconstituted Kogenate FS if it is not clear to slightly cloudy and colorless.

What are the ingredients in Kogenate FS?

Active ingredients: antihemophilic factor, human recombinant

Inactive ingredients: calcium, chloride ion, copper, glycine, histidine, polysorbate 80, sodium polymetaphosphate, sucrose, tri-n-butyl phosphate, water.

Label

PRINCIPAL DISPLAY PANEL

• Kogenate FS with Vial Adapter Carton 500 IU
• NDC 0026-3783-35
• Kogenate FS
• Antihemophilic Factor
  (Recombinant)
• Formulated with Sucrose
  with Vial Adapter
  Recombinant Factor VIII
• With Vial Adapter for Needleless Reconstitution
• 2.5 mL
• Bayer HealthCare

PRINCIPAL DISPLAY PANEL

 

• Kogenate FS with Vial Adapter Carton 1000 IU
• NDC 0026-3785-55
• Kogenate FS
• Antihemophilic Factor
  (Recombinant)
• Formulated with Sucrose
  with Vial Adapter
  Recombinant Factor VIII
• With Vial Adapter for Needleless Reconstitution
• 2.5 mL
• Bayer HealthCare

SRC: NLM .