Index of drugs

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). The product does not contain von Willebrand factor and is therefore not indicated for the treatment of von Willebrand's disease.

1 vial contains nominally 250 IU, 500 IU. or 1000 IU octocog alfa - recombinant coagulation factor VIII, obtained by genetic engineering in Chinese hamster ovary cells. After reconstitution, 1 ml of solution for injection contains 25 IU, 50 IU, respectively. or 100 IU octocog alfa. The specific activity is about 4000 - 8000 IU / mg of protein. The product contains 1.5 mmol sodium per dose.

The product contains recombinant blood coagulation factor VIII (octocog alfa). Vol. VIII, after administration to a patient with haemophilia, binds to endogenous von Willebrand factor in the patient's circulatory system. Activated part VIII accelerates the conversion of parts X to activated part X. Activated part X transforms prothrombin into thrombin, and this converts fibrinogen to fibrin, which makes it possible to form a clot. Medium T_0,5 drug is approximately 14.6 +/- 4.9 hours and does not significantly differ statistically from the antihemophilic (human) factor obtained from the plasma. The calculated ratio of actual and expected recovery (ie 2% increase in activity of part VIII after administration of 1 IU rAHF / kg body weight) for the preparation (121.2 +/- 48.9%) is similar to the preparation containing anthemophilic factor obtained from plasma (123.4 +/- 16.7%).

Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to bovine, murine or hamster protein.

The generation of neutralizing antibodies should be monitored. VIII (inhibitors), through appropriate clinical observation and laboratory tests. The risk of developing inhibitors depends on the period of exposure to VIII, the risk being highest during the first 20 days of exposure and from other genetic and environmental factors. In rare cases, inhibitors may be formed after the first 100 days of exposure. There were cases of re-emergence of the inhibitor (low titre) following the change of one recombinant preparation. VIII for another preparation, in patients previously exposed for more than 100 days, and who had an inhibitor in the past. The drug should be discontinued if an allergic or anaphylactic reaction occurs; in case of shock, appropriate treatment should be used. The sodium content of the preparation should be taken into account in patients on a low sodium diet.

There are no studies on the effect of the medicine on reproduction in animals. Lack of experience in the use of the preparation in pregnant and breastfeeding women - use only in the case of clear indications.

Common: inhibition of cz VIII (mainly in patients previously untreated), chills. Uncommon: otitis, dizziness, tremor, nosebleed, flushing, bruising, hypotension, irritation, chills, sore throat and larynx, nausea, sweating, pruritus, rash, maculopapular rash, limb pain, fatigue , fever, abnormalities in the acoustic stimulation test. Not known: hypersensitivity reactions, anaphylactic shock, syncope, headache, cyanosis, tachycardia, dyspnea, cough, tightness in the chest, wheezing, vomiting, abdominal discomfort, urticaria, skin peeling.

Administration of the drug should be initiated under the supervision of a physician experienced in the treatment of haemophilia. The preparation can be used in adults and children of all age groups, including newborns. Activity VIII in plasma is expressed either as a percentage (relative to the norm for human plasma) or in IU. (with reference to the international standard, part VIII in plasma). International unit (IU) part VIII is equivalent to the number of parts VIII in 1 ml of normal human plasma.Substitution treatment. The necessary dose of factor VIII is determined using the following formula: required dose (IU) = body weight (kg) x desired factor VIII (%) x 0.5 or according to the formula: expected factor VIII increase (%) = 2 x amount given IU : body weight (kg). The dose, frequency of administration and duration of substitution treatment must be adjusted individually to the patient's needs (they depend on the degree of deficiency in part VIII, on the location and extent of the bleeding and on the patient's clinical condition). The recommendations for individual minimum levels are given below. VIII in the blood in various types of bleeding.Early bleeding into the joints, muscles or the oral cavity - required level of VIII is 20-40 (% or IU / dl): repeat infusion every 12-24 h, at least 1-3 days, until the bleeding resolves, as indicated by the resolution of pain or healing. More severe bleeding to the joints, muscles or hematoma - required level of VIII is 30-60 (% or IU / dl): repeat infusions every 12-24 h, for 3 days or more, until the pain and recovery are relieved. Life-threatening hemorrhages (intracranial, bleeding to the throat or severe abdominal bleeding) - required level of VIII is 60-100 (% or IU / dL): repeat infusions every 8-24 h, until the hazard disappears. Small surgical procedures, including tooth extraction - required level of VIII is 30-60 (% or IU / dL): repeat infusions every 24 h, at least 1 day, until healing; in approximately 70% of cases a single infusion and oral anti-fibrinolytic therapy are sufficient. Major surgical procedures - required level of VIII is 80-100 (% or IU / dL), in the pre- and postoperative period: repeat infusions every 8-24 h, depending on the course of the wound healing process. The dose and frequency of administration should each time be adjusted to clinical effectiveness in an individual case. Under certain circumstances, the required dose may be greater than the calculated one. During the treatment, it is recommended to correctly determine the levels of VIII, to determine the dose and frequency of repeated injections. If necessary, peak activity should be measured within 0.5 h after administration.Prevention. In the case of long-term prophylaxis of bleeding, patients with severe haemophilia usually use doses of VIII, 20-40 IU / kg at intervals of 2 to 3 days. In some cases, especially in younger patients, it may be necessary to shorten the intervals between doses or to use higher doses.Patients with inhibitors. If the inhibitor concentration does not exceed 10 units of Bethesda (J.B.) / ml, the addition of an additional amount of Coagulation VIII may neutralize the inhibitor, followed by the administration of additional units of VIII should trigger the expected answer. In this situation, concentration control is necessary. VIII by means of laboratory tests. When the inhibitor titer exceeds 10 B./ml, hemostasis control with the help of the measurement of the concentration of VIII may not be possible or difficult due to the need to administer very high doses. Treatment of such patients should be conducted under the guidance of physicians experienced in the care of patients with haemophilia.
The drug should be administered intravenously, after reconstitution with the supplied solvent (water for injections). Administer within 3 hours after reconstitution. After reconstitution, do not refrigerate the solution. Use only infusion components and kits provided by the manufacturer. The speed of administration should be set at a level that ensures the patient's comfort and should not exceed 10 ml / min. The heart rate should be checked before and during treatment. In the event of a significant acceleration of the heart rate, reduce the rate of administration or temporarily stop the injection.