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Kogenate FS

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Kogenate FS

PATIENT INFORMATION

Kogenate FS
(ko-jen-ate) Antihemophilic Factor (Recombinant)

Formulated with Sucrose

This leaflet summarizes important information about Kogenate FS. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Kogenate FS. If you have any questions after reading this, ask your healthcare provider.

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

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 prevent and control bleeding in adults and children (0-16 years) 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 and reduce the risk of joint damage in children.

Kogenate FS is not used to treat von Willebrand's Disease.

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.

Tell your healthcare provider if you are pregnant or breast-feeding because Kogenate FS may not be right for you.

What should I tell my healthcare provider before I use 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 nonprescription medicines, such as over-the-counter medicines, supplements, or herbal remedies.

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

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.

How do 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.

The starting date of room temperature storage should be clearly recorded on the unopened product carton. Once stored at room temperature, the product must not be returned to the refrigerator. The shelf-life then expires after the storage at room temperature, or 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 else should I know about Kogenate FS and hemophilia A?

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.

Instructions for use

How should I take 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 at the end of this leaflet and the specific infusion instruction leaflet provided.

You should always follow the specific instructions given by your healthcare provider. The steps listed below 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.

Reconstitution and use of Kogenate FS

Always work on a clean surface and wash your hands before performing the following procedure. Use only the components for reconstitution and administration that are provided with each package of Kogenate FS. If a package is opened or damaged, do not use this component. If these components cannot be used, please contact your healthcare provider. If you have any questions about Kogenate FS contact Bayer at 1-888-84-BAYER (1-888-842-2937).

1. Warm the unopened diluent and the concentrate to a temperature not to exceed 37°C or 99°F.

2. After removing the plastic flip-top caps (Fig. A), clean the rubber stoppers of both bottles with alcohol wipes. Be careful not to handle the rubber stopper.

Figure A

Remove the plastic flip-top caps - Illustration

3. Remove the cover from one end of the plastic transfer needle cartridge and insert into the stopper of the diluent bottle (Fig. B).

Figure B

KOGENATE FS [Antihemophilic Factor (Recombinant), Formulated
with Sucrose] Figure B Illustration

4. Remove the rest of the cover from the needle cartridge. Turn over the diluent bottle. With the needle at an angle, insert into the rubber seal on the concentrate bottle (Fig. C).

Figure C

Insert needle into the rubber seal - Illustration

5. The vacuum will suck the diluent into the concentrate bottle. Hold the diluent bottle at an angle to the concentrate bottle in order to direct the stream of diluent against the wall of the concentrate bottle (Fig. C). Avoid too much foaming. If the diluent does not get into the bottle, the product should not be used.

6. Remove the diluent bottle and transfer needle (Fig. D). Gently, swirl the bottle until the Kogenate FS infusion liquid is dissolved. Be careful not to create foam (Fig. E). Throw away any liquid that is cloudy, the wrong color, or contains particles.

Figure D and E

KOGENATE FS [Antihemophilic Factor (Recombinant), Formulated
with Sucrose] Figure D AND E Illustration

7. Clean the stopper of the Kogenate FS infusion liquid bottle with an alcohol wipe. Allow the stopper to air dry.

8. Using the filter needle from the infusion set, suck the infusion liquid into the syringe (Fig. F). Replace the filter needle with the vein needle from the infusion set and follow the specific instructions for infusion provided in the accompanying infusion set leaflet.

Figure F

KOGENATE FS [Antihemophilic Factor (Recombinant), Formulated
with Sucrose] Figure F Illustration

9. If the same patient is getting more than one bottle for an infusion, the contents of two infusion liquid bottles can be sucked into the same syringe using separate unused filter needles before attaching the vein needle.

Rate of administration

The entire dose of Kogenate FS can usually be infused within 1 to 15 minutes. However, your healthcare provider will determine the rate of administration that is best for you.

Resources at Bayer available to the patient:

For Adverse Reaction Reporting contact: Bayer Medical Communications 1-888-84-BAYER (1-888-842-2937).

Contact Bayer to receive more product information: Kogenate FS Customer Service 1-888-606-3780. Bayer Reimbursement HELPline 1-800-288-8374. For more information, visit www.kogenatefs.com

Last reviewed on RxList: 4/4/2014
This monograph has been modified to include the generic and brand name in many instances.

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