Oktokog alpha
When ATH:
B02BD02
Pharmacological action
Recombinant antihemophilic factor. Acts like endogenous clotting factor VIII. Factor VIII is an essential component in the process of clotting. As a cofactor for Factor XI, it accelerates the activation of factor X. Activated Factor X converts prothrombin to thrombin, which, in turn converts fibrinogen to fibrin, which leads to clot formation. Factor VIII activity was significantly decreased in patients with hemophilia A. Replacement therapy increases the level of factor VIII in the blood plasma, temporarily corrects its deficiency in the blood plasma and prevents bleeding.
Pharmacokinetics
The concentration of alpha oktokoga after infusion 50 IU / kg – 123.9± 47.7 IU / 100 ml. T1/2 – 14.6± 4.9.
Testimony
Hemophilia A (treatment and prevention of bleeding, incl. Surgical).
Dosage regimen
B /, not later than 3 hours after preparation (Upon formulation, solutions can not be stored in the refrigerator), speeds up 10 ml / min. Injectable solution should be at room temperature. In the event of a significant tachycardia, It should reduce the rate of administration or temporarily stop the introduction of the alpha oktokoga.
Expected in vivo increase in alpha oktokoga (IU / dL plasma or% of normal), It can be calculated by multiplying 2 injected dose / kg body weight (IU / kg). Example: dose 1750 ME октокога альфа, administering to a patient with a body weight 70 kg, ie. 25 IU / kg body weight (1750/70), It should lead to the maximum increase factor VIII postinfuzionnomu on 25 x 2% = 50% (% from the norm). The maximum level 70% It is required for a child, weight which is 40 kg. In this case, the dose will be 70/2 x 40 = 1400 ME.
The dosage regimen and duration of treatment depends on the severity of disorders of hemostasis, and the clinical condition of the patient. The necessary level of Factor VIII in the blood (% or IU / dL plasma) and the multiplicity of infusion depends on the degree of bleeding.
If early signs of hemarthrosis, or bleeding into the muscle or bleeding in the mouth necessary level of factor VIII – 2-4 IU / mL (or%) every 12-24 hours, within at least 1 days until complete relief of bleeding episodes, as evidenced by the absence of pain or healing.
Hemarthrosises and bleeding in the muscle of moderate severity or hematoma: the necessary level of factor VIII – 3-6 IU / mL (or%) every 12-24 h for 3-4 day or more to complete relief of pain and restoration of motor activity.
Life-threatening bleeding (pharyngeal bleeding, bleeding into the abdominal cavity, gemotoraks, as well as surgical interventions Color): the necessary level of factor VIII – 6-10 IU / mL (or%) every 8-24 h until the complete cessation of bleeding.
Minor surgery, including tooth extraction: the necessary level of factor VIII – 6-8 IU / mL (or%). Single infusion or oral application antifibrinolytic therapy for 1 h is usually sufficient to 70% cases.
Large oral surgery: the necessary level of factor VIII – 8-10 IU / mL (or%) every 8-24 h to adequate wound healing, then therapy for at least 7 day to maintain the activity of factor VIII level 30-60%
Side effect
Maybe: nausea, feeling the heat, easy fatigue, rash, hematoma, Sweating, itch, tremor, fever, pain in the legs, cold extremities, dry throat, inflammatory diseases of the ear and hearing loss.
Allergic reactions: hives, rash, anaphylaxis (dyspnoea, cough, chest pain, decrease in blood pressure). The appearance of antibodies (inhibitors) Factor VIII (expressed as inefficient clinical response).
Contraindications
Hypersensitivity to the active substance (incl. proteins cattle, mice or hamsters).
Pregnancy and lactation
Effects on reproductive function have not been studied.
Use in pregnancy and lactation with caution in cases, when the expected benefit of therapy to the mother outweighs the potential risk to the fetus or infant.
Cautions
C wary of thrombosis, thromboembolism, myocardial infarction, DIC and conditions, where a high risk of developing these complications.
Treatment should be under the supervision of a specialist doctor with regular monitoring concentration of antihemophilic factor in the patient's plasma. Careful monitoring of the therapy is especially necessary in the case of surgical interventions or the occurrence of life-threatening bleeding.
If the concentration of antihemophilic factor in blood plasma does not reach the expected level or after the administration of sufficient doses expectation bleeding stops, there is reason to assume the presence of an inhibitor. In laboratory tests, the presence of the inhibitor can be detected and quantified in neutralized ME antihemophilic factor in each ml of plasma (Bethesda units) or in total plasma. If less than the activity of the inhibitor 10 units Bethesda / ml, introduction of an additional dose of antihemophilic factor may neutralize its effect. In such a situation requires careful laboratory monitoring level antihemophilic factor. The risk of such complications is correlated with the introduction of antihemophilic factor VIII, This risk is greatest during the first 20 day administration of alpha oktokoga.
It should warn the patient about the possible signs of an allergic reaction, and when they occur to halt the use of alpha oktokoga. Particular caution should be exercised in patients with a known allergy to the components of the drug. Allergic reactions are severe contraindication to the introduction of the alpha oktokoga. If an anaphylactic reaction occurs, stop administering oktokoga alpha and begin to carry out common activities protivoshokovym.
Oktokog alpha can be used in children of all ages, including newborns (relevant studies on safety and efficacy performed as in previously treated, and previously untreated children).
Since oktokog alpha contains only recombinant factor VIII, it is not intended to treat patients with von Willebrand's disease.
Drug Interactions
Oktokog alpha should not be mixed with other drugs.
