Kogenate® FS (antihemophilic factor recombinant) Antihemophilic Factor (Recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Kogenate FS (antihemophilic factor recombinant) is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.¹ 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 (antihemophilic factor recombinant) is a highly 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 FVIII derived from human plasma. Compared to its predecessor product KOGENATE® Antihemophilic Factor (Recombinant), Kogenate FS (antihemophilic factor recombinant) incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human). The purification process includes an effective solvent/detergent virus inactivation step in addition to the use of the classical purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant FVIII and remove contaminating substances.

Kogenate FS (antihemophilic factor recombinant) is formulated with sucrose (0.9-1.3%), glycine (21-25 mg/mL), and histidine (18-23 mM) as stabilizers in the final container in place of Albumin (Human) as used in KOGENATE, and is then lyophilized. The final product also contains calcium chloride (2-3 mM), sodium (27-36 mEq/L), chloride (32-40 mEq/L), polysorbate 80 (not more than [NMT] 96 µg/mL), imidazole (NMT 20 µg/1000 IU), tri-n-butyl phosphate (NMT 5 µg/1000 IU), and copper (NMT 0.6 µg/1000 IU). The product contains no preservatives. The amount of sucrose in each vial is 28 mg. Intravenous administration of sucrose contained in Kogenate FS (antihemophilic factor recombinant) will not affect blood glucose levels.

Each vial of Kogenate FS (antihemophilic factor recombinant) contains the labeled amount of recombinant FVIII in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation FVIII, human, is approximately equal to the level of FVIII activity found in 1 mL of fresh pooled human plasma. Kogenate FS (antihemophilic factor recombinant) must be administered by the intravenous route.

REFERENCES

1.  Lawn RM, Vehar GA: The molecular genetics of hemophilia. Sci Am 254(3):48-54, 1986.

SIDE EFFECTS: Flushing of the face, headache, nausea, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, and chills may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.