Oktokog alfa (Octocogum alfa)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Coagulants (including clotting factors), hemostatics

Included in the formulation
  • Adv
    lyophilizate in / in 
    Baxter AG     Austria
  • Kogenate FS
    lyophilizate in / in 
    Bayer Helscher LLS     USA
  • Recombinant
    lyophilizate in / in 
    Baxter, C.A.     Belgium
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    B.02.B.D.02   Coagulation factor VIII

    Pharmacodynamics:

    The drug is a recombinant anti-hemophilic factor of blood coagulability VIII and it works the same way.

    As a cofactor for factor XI, it accelerates the activation of factor X. Activated factor X translates prothrombin into thrombin, which, in turn, converts fibrinogen into fibrin, which leads to the formation of a clot. Factor VIII activity is significantly reduced in patients with hemophilia A. Substitution therapy increases the level of factor VIII in blood plasma, which temporarily corrects its deficiency in blood plasma and prevents bleeding.

    Pharmacokinetics:

    The mean recovery of factor VIII activity measured 10 minutes after infusion in octokogalpha was (2.1 ± 0.3)% /IU/ kg. The half-life period is 14.6 ± 4.9 h.

    Indications:

    Prevention and treatment of bleeding episodes in hemophilia A.

    ICD-10

    III.D65-D69.D66   Hereditary deficiency of factor VIII

    Contraindications:

    Known hypersensitivity or allergic reactions to the components of the drug.

    Known hypersensitivity to mouse or hamster proteins.

    Carefully:

    Thrombosis, myocardial infarction, thromboembolism, myocardial infarction, syndrome of disseminated intravascular coagulation, pregnancy, breast-feeding.

    Pregnancy and lactation:

    No studies have been conducted. Use during pregnancy and lactation with caution and in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus or infant.

    Dosing and Administration:

    Intravenously, dose = (body weight (kg) × desired% increase in coagulation factor VIII): 2% / IU / kg.

    Side effects:

    From the nervous system: dysgeusia (unusual taste in the mouth), headache, dizziness, memory impairment, tremor, migraine.

    Disorders from the side of the organ of vision: inflammation of the eyes.

    From the immune system: skin / systemic hypersensitivity reactions, the formation of antibodies that neutralize factor VIII (mainly in patients previously untreated with factor VIII drugs or who received minimal treatment).

    From the cardiovascular system: inhibition of clotting factor VIII, hematoma, flushes of blood, pallor.

    From the gastrointestinal tract: diarrhea, pain in the upper abdominal cavity, nausea, vomiting.

    From the skin and subcutaneous tissues: itching, rash, hyperhidrosis, diaper dermatitis.

    From the respiratory system, chest and mediastinum: dyspnoea.

    General reactions and reactions at the site of administration: febrile reaction during infusion, redness and itching at the injection site, peripheral edema, chest pain, impaired well-being, malaise, weakness.

    Infectious and parasitic diseases: influenza, laryngitis, lymphangitis.

    Overdose:

    Not described.

    Interaction:

    It is not recommended to mix with other drugs.

    Special instructions:

    Prevention

    Concentrates antihemophilic factor can also be administered on a regular basis to prevent bleeding.

    Preparation of the drug, its administration and all manipulations with the system for the administration of the drug should be carried out with the utmost care. The drug with the 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, including HIV (AIDS) and hepatitis. In case of injury, immediately seek medical help. Needles should be placed in the attached containers immediately after use, all devices for preparation and administration of the preparation, including the remains of the prepared solution, should be disposed of in the appropriate container.

    Preparation of the solution

    1. Wash your hands thoroughly with warm water and soap.

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

    3. Remove the protective cap from the bottle. 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. Try not to 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. Ensure 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. Now 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. 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 preparation and enter the solution intravenously.

    Note: follow the instructions for using the supplied infusion system.

    13. If the patient is required to enter more than one vial, 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. Parenteral drugs, if allowed by the solution and container, should be carefully inspected for foreign particles or discoloration before administration.

    The rate of administration is determined in accordance with the individual reaction of the patient. Typically, the entire dose for 5-10 minutes and even faster, is tolerated well.

    After preparation, the solution should be introduced within 3 hours. For the introduction it is recommended to use the enclosed system.

    It is necessary to warn the patient about possible signs of allergic reactions and at their occurrence stop application of octokogalpha. Particular care should be taken in patients with known allergies to the components of the drug. Allergic reactions of severe degree are a contraindication to the introduction of octokogalpha.If an anaphylactic reaction occurs, immediately stop the introduction of octokogalpha and initiate conventional anti-shock measures.

    Octocog alfa can be used in children of any age, including newborns (corresponding studies on safety and efficacy have been conducted in previously treated and previously untreated children).

    Because the octobic alpha contains only recombinant VIII factor, it is not intended for treatment of patients with von Willebrand disease.

    Impact on the ability to drive vehicles and manage mechanisms

    The drug does not affect the ability to drive and the ability to work with machinery.

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