Universal reference book for medicines
Product name: Kogenate FS (Kogenate FS)

Active substance: octocog alfa

Type: Coagulation factor VIII drug

Manufacturer: BAYER HealthCare (USA)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration complete with a solvent (water d / i)
in the form of a white with a yellowish tinge of powder;
the prepared solution is clear, from colorless to slightly yellowish in color.
1 f.

octokog alpha (antihemophilic / recombinant / clotting factor VIII) 250 IU *

- "- 500 IU *

- "- 1000 IU *

Excipients: histidine - 8 mg, glycine - 58 mg, sodium chloride - 4.4 mg, calcium chloride - 0.7 mg, polysorbate 80 - 200 Ојg, sucrose - 28 mg.

Solvent: water d / u - 2.5 ml.

Vials of colorless glass (1) complete with a glass syringe with solvent (1) in the blister, adapter for the bottle (1) in the blister, device d / in / in the introduction (1) in the blister - packs cardboard.

Lyophilizate for the preparation of a solution for intravenous administration complete with a solvent (water d / i) in the form of a white with a yellowish tinge of powder;
the prepared solution is clear, from colorless to slightly yellowish in color.
1 f.

octochogram alpha (antihemophilic / recombinant / clotting factor VIII) 2000 IU *

Excipients: histidine - 16 mg, glycine - 116 mg, sodium chloride - 4.4 mg, calcium chloride - 0.7 mg, polysorbate 80 - 400 Ојg, sucrose - 56 mg.

Solvent: water d / u - 5 ml.

Vials of colorless glass (1) complete with a glass syringe with solvent (1) in the blister, adapter for the bottle (1) in the blister, device d / in / in the introduction (1) in the blister - packs cardboard.

* According to the WHO standard for coagulation factor VIII, 1 IU is approximately equal to the level of anti-hemophilic factor found in 1.0 ml of a pool of fresh human plasma.


Description of the drug approved by the manufacturer for the printed edition of 2013.


The haemostatic preparation is a highly purified glycoprotein consisting of several peptides, including one with a molecular weight of 80 kD and various dilated subunits with a molecular weight of 90 kD.
Manufactured using recombinant DNA technology. It is produced by baby hamster kidney (BHK) cells into which the human blood clotting factor VIII (FVIII) gene was introduced. The cell culture medium contains a solution of human plasma proteins (HPPS) and recombinant insulin, but does not contain proteins derived from animal sources. Kogenate FS has the same biological activity as factor VIII, obtained from human blood plasma.
The purification process involves a viral inactivation step with an effective solvent / detergent in addition to the classical purification methods by ion exchange chromatography, immunoaffinity chromatography with monoclonal antibodies, along with other chromatographic steps designed to purify the recombinant factor VIII and remove the infecting components.

In addition, the manufacturing process was investigated for its ability to reduce the infectivity of the experimental agent with transmission spongiform encephalopathy (TGE), which was considered as a model of CJF agents (Craytsfeldt-Jakob disease) and CJD variant.
It was shown that a number of separate stages of production and preparation of the feedstock in the process of manufacturing Kogenate FS reduces the infectivity of this experimental model of the agent. Steps to reduce TEG infectivity included the separation of fraction II + III in the solution of human plasma proteins (6.0 log 10 ) and the step of anion exchange chromatography (3.6 log 10 ). These studies provide a reasonable assurance that, if the CJD / CJD variant with a low infectivity is present in the source material, it can be eliminated.
Introduction Coagenate FS provides an increase in the content of factor VIII in blood plasma and temporarily eliminates the coagulation defect in patients with haemophilia A (hereditary bleeding, characterized by insufficient activity of a specific plasma protein, VIII coagulation factor).

Each flask of Cohenate FS contains the recombinant factor VIII in international units (ME) indicated on the label.
According to the WHO standard for the coagulation factor of human VIII, 1 ME is approximately equal to the level of activity of factor VIII in 1 ml of a pool of fresh human plasma.

The mean recovery of factor VIII activity, measured 10 minutes after the infusion of Cohenate FS, was 2.1 В± 0.3% / IU / kg.
The mean biological T 1/2 of therecombinant factor VIII (rFVIII-FS) containing sucrose was approximately 13 hours and was similar to the T 1/2 anti-hemophilic factor (AHF) obtained from human blood plasma. Kogenate FS shortened APTTV. Restoration of the activity of the factor rFVIII-FS and its T 1/2 did not change after 24 weeks of treatment with this preparation alone, which indicates the preservation of efficacy and the absence of formation of antibodies to factor VIII. The mean recovery of factor VIII activity, measured 10 minutes after the administration of the rFVIII-FS dose to 37 patients (after 24 weeks of treatment with rFVIII-FS), was 2.1% / IU / kg, which did not differ from the recovery factor of factor VIII activity, which was determined at baseline level, and after 4 and 12 weeks of treatment.

- prevention and treatment of bleeding episodes in hemophilia A.


The following doses are indicative.
The dose of Kogenate FS necessary to restore hemostasis should be selected individually, depending on the intensity of bleeding, the presence of inhibitors and the desired level of factor VIII. During the treatment, it may be necessary to monitor the content of factor VIII. The clinical effect of factor VIII is the most important in assessing the effectiveness of treatment. To achieve a satisfactory clinical result, a higher dose of factor VIII may be required than was calculated. If, after the administration of the calculated dose, it is not possible to provide the expected concentration of factor VIII or to control bleeding, it should be assumed that the patient has a factor VIII inhibitor in the blood. Its presence and quantity (titer) should be confirmed by appropriate laboratory tests. In the presence of an inhibitor, the dose of factor VIII in different patients can vary significantly, and the optimal treatment regimen is determined only by taking into account the clinical response.
Some patients with a low titer of inhibitors (<10 Bethesda units) can be successfully treated with preparations of factor VIII without anamnestic increase in the titer of inhibitors.
To ensure an adequate response, it is necessary to check the level of factor VIII and the clinical response to treatment. Patients with an anamnestic response to treatment with factor VIII and / or with higher inhibitor titers may require the use of alternative medications such as factor IX complex concentrates, antihemophilic factor (porcine), recombinant factor VIIa or anti-coagulation complex.
The percentage increase in the level of factor VIII in vivo can be calculated by the formula: the dose of Cogenate FS in IU / kg of body weight x 2% / IU / kg.
This calculation method is based on clinical data on the use of plasma derived and recombinant AHF products and is illustrated in the following examples:
Expected% increase in factor VIII = (number of units administered? 2% / IU / kg) / body weight (kg).

Example of calculating the dose for an adult weighing 70 kg: (1400 IU? 2% / IU / kg) / 70 kg = 40%.

The required dose (ME) = (body weight (kg) is the desired% increase in factor VIII) / 2% / IU / kg.

Example of calculating the dose for a child weighing 15 kg: (15 kg-100%) / 2% / IU / kg = 750 ME is required.

The dose needed to achieve full hemostasis is determined by the type and severity of the haemorrhagic episode, according to the following recommendations:

Type of bleeding Therapeutically necessary level of activity of factor VIII in plasma The dose of the drug necessary to maintain a therapeutic level of factor VIII in plasma

Small bleeding (superficial hemorrhages, early bleeding, bleeding in the joints) 20-40% 10-20 IU / kg body weight.
Introduce a second dose if symptoms persist of bleeding.
Moderate-expressed bleeding (hemorrhages in the muscles, bleeding in the oral cavity, obvious hemarthrosis, obvious trauma) Small surgical interventions 30-60% 15-30 IU / kg body weight.
If necessary, repeat the administration at the same dose after 12-24 hours.
Expressed and life-threatening bleeding (intracranial bleeding, bleeding to the abdominal, thoracic cavity, central nervous system, retrofariring or retroperitoneal space, ileal-lumbar muscle capsule) Fractures Head trauma 80-100% The initial dose is 40-50 IU / kg body weight.
Repeated dose of 20-25 IU / kg body weight every 8-12 hours.
Extensive surgery 100% Preoperative dose - 50 IU / kg body weight.
Ensure 100% activity before surgery. Repeat the introduction initially 6-12 hours after the operation, continuing treatment for 10-14 days until complete healing.
Concentrates of AGF can also be administered regularly to prevent bleeding .

The drug is administered only by IV injection or infusion.
After preparation the solution should be introduced within 3 hours. For the introduction it is recommended to use the enclosed system.
The rate of administration is determined according to the individual reaction of the patient.
Typically, the entire dose for 5-10 minutes and even faster, is tolerated well.
Rules for the preparation of solution

Preparation of the drug, its administration and all manipulations with the system for administration should be carried out with the utmost care.
Kogenate FS with adapter for the bottle is a needleless system that allows you to prevent injuries as a result of pricking with a needle during the preparation of the solution. If the skin is damaged by a needle contaminated with blood, viruses of various infections can be transmitted, incl. HIV (AIDS) and hepatitis. In case of injury, immediately seek medical help. Needles should be placed in the enclosed containers immediately after use, all preparations for preparation and administration of the preparation, including the remains of the prepared Kogenate FS solution, should be disposed of in the appropriate container.
1. Wash your hands thoroughly with warm water and soap.

2. Warm the closed vial and the syringe in the hands to room temperature (no higher than 37 В° C).

3. Remove the protective cap from the bottle (A).
Disinfect alcohol with alcohol rubber stopper, trying not to touch the rubber stopper with your hands.
4. Place the vial with the drug on a hard, non-slippery surface.
Remove the paper cover from the plastic adapter cartridge for the vial. Do not remove the adapter from the plastic cartridge. Take the cartridge with the adapter, place it on the bottle with the drug and press it hard. The adapter snaps into place on the lid of the vial. Do not remove the cartridge from the adapter at this point.
5. Carefully open the blister pack of the syringe by bending the paper cover to the middle.
Remove pre-filled syringe with solvent. Taking the rod of the piston by the top nozzle, get it out of the package. Do not touch the sides and threads of the piston rod. Holding the syringe straight, take the plunger from the top nozzle and attach the rod, tightly screwing it clockwise into the screw with a thread.
6. Taking the syringe by the body, break off the tip of the syringe.
It must be ensured that the tip of the syringe does not come into contact with the hand or any other surface. Delay the syringe until the next manipulation.
7. Remove the adapter cartridge and discard it.

8. Attach the pre-filled syringe by turning it clockwise to the threaded adapter of the vial.

9. Introduce the solvent by slowly pressing the piston rod.

10. Carefully rotate the vial until all of the substance has dissolved.
Do not shake the bottle. Make sure that the powder is completely dissolved. Do not use the solution if it is cloudy or contains visible particles.
11. Draw the solution into the syringe, holding the bottle over the edge above the bottle adapter and the syringe, and then slowly and smoothly pull the piston rod.
It is necessary to make sure that the entire contents of the vial are typed in a syringe.
12. Without changing the position of the piston, remove the syringe from the bottle adapter (the latter must remain attached to the vial).
Attach the syringe to the attached system for administering the drug and inject the IV solution. Follow the instructions for using the supplied infusion system.
13. If the patient is required to enter more than one vial, you should prepare the solution in each vial using the supplied syringe with the solvent, and then connect the solutions in a larger syringe (not supplied) and administer the drug in the usual manner.

14. Drugs for parenteral administration prior to administration should be carefully examined for foreign particles or discoloration if the solution and container permit.


From the side of the central nervous system: in isolated cases - dizziness, depersonalization.

Dermatological reactions: in rare cases - rash, itching.

From the digestive system: in isolated cases - unusual taste in the mouth, nausea.

Other: in isolated cases - moderate increase in blood pressure, rhinitis, reactions at the injection site.


- hypersensitivity to the components of the drug;

- Hypersensitivity to proteins of mice or hamsters.


There is no data on the use of Kogenate FS in pregnancy.
It is unknown whether the drug can cause fetal damage or affect reproductive capacity when administered to a pregnant woman.
The use of the drug during pregnancy and during lactation is possible only in the presence of absolute indications.

Experimental studies of the influence of Kogenate FS on reproductive functions in animals have not been conducted.


Kogenate FS can be used to treat children.
Safety and efficacy studies were conducted in children (n = 62) who had not previously received treatment and received minimal treatment.

In the literature, cases of arterial hypotension, urticaria and chest tightness are described in connection with hypersensitivity reactions in patients treated with antigemophilic factor concentrates.
With the development of serious anaphylactic reactions, immediate emergency treatment with resuscitation, such as epinephrine and oxygen, is required.
Kogenate FS is designed to treat episodes of bleeding caused by a deficiency of factor VIII .
The presence of this deficiency should be established before the introduction of Kogenate FS.
Kogenate FS does not contain vWF, so it is not indicated for the treatment of von Willebrand disease.

During the treatment of patients with hemophilia A, circulating neutralizing antibodies (inhibitors) can be formed to factor VIII.
Inhibitors are especially frequent in the early years of treatment in young children with severe hemophilia or in those who previously received a limited amount of factor VIII. However, the appearance of inhibitors is possible at any time during the treatment of a patient with hemophilia A. Patients receiving treatment with any drug AGF, incl. Coagenite FS, need careful monitoring to detect antibodies to factor VIII through proper clinical observation and laboratory tests in accordance with the recommendations of the Center for the Treatment of Haemophilia. During clinical trials with pre-treated patients, 109 adverse events were registered per 4160 infusions (2.6%). The presence of at least a distant connection with the study drug was noted by the researcher only in 13 of these phenomena. Another 7 undesirable phenomena could not be evaluated. Thus, 20 adverse events in 11 patients were considered either as not measurable or at least remotely related to the use of Cohenate FS at a frequency of 0.5% relative to the number of infusions produced. In 72 pretreated patients with severe hemophilia A who received Cohenate FS, an average of 54 inhibitors of factor VIII was not detected on average.
In clinical trials, all patients were tested for seroconversion with respect to mouse and hamster proteins.
After treatment, specific antibodies to these proteins were not developed in any of the patients, and no serious allergic reactions associated with animal proteins were observed with rFVIII-FS infusions. Despite this, patients should be informed of the possibility of developing a hypersensitivity reaction to mouse and / or hamster proteins and are warned about early signs of such a reaction (eg, urticaria, localized or generalized urticaria, wheezing and arterial hypotension). Patients should be advised to stop using the drug when symptoms occur and contact their doctor.
Clinical studies of Cohenate FS did not include a sufficient number of patients aged 65 years and older to determine whether their response to treatment differs from that of younger patients.
As with any patient receiving Cohenate FS, the dose for elderly patients should be selected individually.
Use in Pediatrics

Kogenate FS can be used to treat children.
Safety and efficacy studies were conducted in children (n = 62) who had not previously received treatment and received minimal treatment.
Impact on the ability to drive vehicles and manage mechanisms

There is no information that the administration of Kogenate FS drug may reduce your ability to drive or operate machines.
The results of experimental investigations
conducted in vitro analysis of the mutagenic potential of rFVIII in doses significantly exceeding the maximum therapeutic dose, did not reveal reverse mutation or chromosomal aberrations. Investigation of rFVIII in vivo in animals with doses in excess of 10-40 times the maximum expected therapeutic, also showed that rFVIII has no mutagenic potential. Long-term studies for carcinogenic potential have not been conducted in animals.

Symptoms of an overdose of the drug Kogenate FS is unknown.

Drug interaction Kogenate FS formulation is not known.

Drug prescription.

The drug should be stored out of reach of children, protected from light at a temperature of 2 В° to 8 В° C;
Do not freeze. Shelf life of the lyophilisate - 30 months, solvent - 48 months.
Storing permitted the drug at a temperature not higher than 25 В° C is not more than 3 months, for example, in the treatment at home.
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