Composition, form of production and packaging
The solution for infusions is transparent or slightly opalescent, from colorless to light yellow in color.
plasma protein 100 mg
in t.ch. IgG not less than 95%
Excipients: maltose, tributyl phosphate, octoxynol, water d / u.
20 ml - bottles (1) - packs of cardboard.
50 ml - bottles (1) - packs of cardboard.
100 ml - bottles (1) - packs of cardboard.
200 ml - bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Octagam В® 10% is a solution of normal immunoglobulin (class G) with a wide range of antibodies to the pathogens of various infections. The drug is produced from a pooled plasma, obtained from at least 3500 donors, and contains antibodies present in the plasma of healthy people. Immunoglobulin G molecules are not changed due to chemical or enzymatic action, the activity of antibodies is completely preserved. The distribution of subclasses of immunoglobulin G is close to that in native human plasma.
Effective doses of the drug restore the low level of immunoglobulin G to its normal value. The drug has immunomodulatory properties.
After IV introduction, the drug immediately enters the systemic circulation, relatively quickly redistributed between plasma and extravascular space. The equilibrium state is achieved after 3-5 days. T 1/2 is about 24-36 days, T 1/2 can vary in different patients, especially in people with primary immunodeficiency. Immunoglobulin G and immune complexes with immunoglobulin G are destroyed by cells of the reticuloendothelial system.
1. Substitution therapy.
Syndromes of primary immunodeficiency:
- congenital agammaglobulinemia and hypogammaglobulinemia;
- unclassifiable variable immunodeficiency;
- severe combined immunodeficiencies;
- Wiskott-Aldrich syndrome;
Myeloma or chronic lymphatic leukemia with severe secondary hypogammaglobulinemia and relapsing infections.
Congenital HIV infection with recurrent infections in children.
2. Immunomodulatory therapy.
Idiopathic thrombocytopenic purpura (ITP) in adults and children with a high risk of bleeding or before surgery to correct the number of platelets.
3. Allogeneic bone marrow transplantation.
The drug is administered iv. Before starting the solution, the temperature of the solution should be brought to room temperature. The solution should be clear or slightly opalescent. Do not use turbid and precipitated solutions.
With each administration of the drug, it is recommended that its name and series number be recorded in the patient's medical history or medical record in order to track the relationship of the patient's condition with the administration of the drug of a particular series. Any amount remaining after the infusion of the drug should be destroyed. The initial rate of administration is from 0.01 to 0.02 ml / kg body weight per minute for 30 min. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 ml / kg body weight per minute.
Dosage regimen and duration of therapy are selected individually, depending on the indications, pharmacokinetic parameters and clinical response in a particular patient.
Substitution therapy for primary immunodeficiencies
The mode of drug administration should ensure that the concentration of immunoglobulin G measured before each subsequent infusion is reached, at least 4.0-6.0 g / l. Since the start of treatment for this requires 3 to 6 months. The recommended initial dose is 0.4-0.8 g / kg body weight, followed by 0.2 g / kg body weight every 3 weeks. The dose required to achieve a concentration of 6.0 g / l is 0.2 to 0.8 g / kg body weight per month. The interval between administrations after reaching the equilibrium state is from 2 to 4 weeks. In order to correct the dosage regimen, the concentration of immunoglobulin G should be measured before each subsequent infusion.
Substitution therapy for myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and relapsing infections; in children with congenital HIV infection and recurrent infections.
The recommended dose is 0.2-0.4 g / kg body weight every 3-4 weeks.
Idiopathic thrombocytopenic purpura (ITP)
In the treatment of acute episodes, 0.8-1.0 g / kg of body weight on the first day, with repeated administration, if necessary, on the third day or 0.4 g / kg of body weight per day, for 2-5 days. Treatment can be repeated in the case of a second episode.
0.4 g / kg body weight per day, for 3-7 days. Experience with children is limited.
1.6-2.0 g / kg body weight is administered in equal doses for 2-5 days or once in a dose of 2.0 g / kg body weight. Patients should simultaneously take acetylsalicylic acid.
Allogeneic bone marrow transplantation
Immunoglobulin is used as a component of preparatory therapy, as well as after transplantation. In the treatment of infectious complications and for the prevention of the development of the "graft versus host" syndrome, the doses of the drug are individually selected. The recommended initial dose is 0.5 g / kg body weight per week, starting 7 days before transplantation. Treatment is continued for 3 months after transplantation. In the case of a permanent deficit of immunoglobulins, it is recommended to inject 0.5 g / kg of body weight monthly until the level of immunoglobulins normalizes.
With the / in the introduction of immunoglobulin, the development of side effects depends on the size of the dose and the rate of administration of the drug.
Frequency of occurrence of undesirable reactions is classified as follows: often (? 1% - <10%), infrequently (? 0.1% - <1%), very rarely (<0.01%).
On the part of the blood system and lymphatic system: very rarely - leukopenia, reversible hemolytic anemia, hemolysis.
From the immune system: often - hypersensitivity reactions; very rarely - anaphylactoid and anaphylactic (including anaphylactic shock) reactions, angioedema, edema of the face.
From the nervous system: often - headache; very rarely - excitation, cerebral circulation, (including stroke), aseptic meningitis, migraine, dizziness, paresthesia.
From the cardiovascular system: very rarely - myocardial infarction, tachycardia, palpitation, cyanosis, thrombosis, circulatory insufficiency, hypotension, hypertension, deep vein thrombosis.
From the respiratory system: very rarely - respiratory failure, pulmonary embolism, pulmonary edema, bronchospasm, dyspnea, cough.
From the gastrointestinal tract: often - nausea; very rarely - vomiting, diarrhea, abdominal pain.
From the skin: infrequently - eczema; very rarely - hives, rashes (including erythematous), dermatitis, itching, alopecia.
From the musculoskeletal system: infrequently - pain in the back; very rarely - arthralgia, myalgia.
From the side of the urinary system: very rarely - acute renal failure, an increase in the concentration of creatinine in the blood.
On the part of laboratory indicators: very rarely - an increase in the values вЂ‹вЂ‹of "liver" enzymes, a false positive increase in the concentration of glucose in the blood.
Other: often - fever, fatigue, reactions at the injection site, infrequently - chills, chest pain; very rarely - flushes to the face, hyperthermia, hyperhidrosis, malaise.Rarely, a sudden drop in blood pressure may occur, and in some cases, anaphylactic shock, including in patients who previously tolerated immunoglobulin well.
Hypersensitivity to the components of the drug; intolerance or hypersensitivity to homologous immunoglobulins, especially in extremely rare cases of immunoglobulin A deficiency when the patient has antibodies to immunoglobulin A.
Carefully. Caution should be exercised when prescribing the drug to obese patients, as well as patients with predisposing risk factors for thrombotic complications such as: advanced age, arterial hypertension, diabetes mellitus, vascular disease, propensity to thrombosis development, prolonged immobility, severe hypovolemia , diseases accompanied by high blood viscosity. This is due to the relative increase in blood viscosity when an immunoglobulin enters the bloodstream, which increases the risk of myocardial infarction, stroke, pulmonary embolism, and deep venous thrombosis.
Because of the possible development of acute renal failure, caution should be exercised when intravenous immunoglobulin is administered to patients with renal insufficiency, diabetes, overweight, hypovolemia, elderly patients (over 65), and patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, the drug is immediately withdrawn.
In patients at risk for developing acute renal failure and thromboembolic complications, the drug is administered with minimal speed and in minimal doses.
PREGNANCY AND LACTATION
The safety of the drug in pregnant women has not been established in controlled clinical trials. In this regard, pregnant and lactating women should be administered with caution. At the same time, the clinical experience of the use of immunoglobulins shows that their administration does not have any negative effect on the course of pregnancy, fetus and newborn. Immunoglobulins are excreted in breast milk, while antibodies can have a protective effect in a newborn.
APPLICATION FOR FUNCTIONS OF THE LIVER
Because of the possible development of acute renal failure, caution should be exercised when intravenous immunoglobulin is administered to patients with renal insufficiency, and also to patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, the drug is immediately withdrawn.
In patients at risk for developing acute renal failure and thromboembolic complications, the drug is administered with minimal speed and in minimal doses.
APPLICATION IN ELDERLY PATIENTS
Caution should be exercised when prescribing the drug to patients with predisposing risk factors for thrombotic complications, such as, for example, old age.
Because of the possible development of acute renal failure, caution should be exercised when intravenous immunoglobulin is administered to elderly patients (over 65 years of age), as well as to patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, the drug is immediately withdrawn.
Due to the fact that the development of some side effects may be associated with the speed of drug administration, strict instructions should be strictly followed.During the administration of the drug, the patient's condition should be carefully monitored.
For all patients receiving intravenous immunoglobulins, it is necessary to conduct adequate hydration before the infusion, monitor diuresis, control the concentration of creatinine in the plasma, exclude the use of "loop" diuretics.
In case of side effects, the speed of the drug should be reduced or completely stopped. Treatment depends on the nature and severity of the side effect. In the event of shock, anti-shock treatment should be initiated in accordance with current treatment standards.
The most common adverse reactions can occur with a high rate of administration, with hypo- and agammaglobulinemia (against a background of deficiency of immunoglobulin A or without it), with the introduction of immunoglobulin for the first time, in rare cases - when transferring to the introduction of an immunoglobulin of another manufacturer, or after a prolonged period after the last infusion. Such patients should be observed during the entire period of the first infusion of the drug, and also within 1 hour after the end of the injection. The remaining patients should be observed during the first 20 minutes of infusion. Standard measures to prevent infections caused by the use of drugs derived from human blood or plasma include selection of donors, testing of individual portions and pools of plasma for specific markers of infection, and the inclusion of effective measures to inactivate / eliminate viruses in the production process. Nevertheless, it is impossible to completely exclude the possibility of carrying infectious agents. This also applies to unknown or newly identified viruses and other pathogenic microorganisms. These measures are considered effective against envelope viruses - HIV, hepatitis B and hepatitis C and to a lesser extent - against the hepatitis A virus and parvovirus B19. The constantly growing clinical experience of the use of human immunoglobulin preparations convincingly indicates that the hepatitis A virus and parvovirus B19 are not transmitted in the treatment of these drugs. The presence of appropriate antibodies in the preparation plays an important role in ensuring antiviral safety. During the treatment period, the transient increase in various passively transmitted antibodies in the patient's blood can lead to false positive results of serological tests. Passive transfer of antibodies to erythrocyte antigens (eg, A, B, D) may affect some serological tests with erythrocyte allo-antibodies (eg, Coombs test).
Due to the presence of maltose (90 mg / ml) in the composition of the preparation, a false positive increase in the patient's glucose concentration determined by some test kits (for example, based on the enzyme glucose dehydrogenase-pyrroloquinoline quinone or glucose-di-oxy reductase reaction) . Elevated values вЂ‹вЂ‹of blood glucose concentration are determined at the time of drug administration and within 15 hours after its completion. In connection with this, unjustified administration of insulin and, as a consequence, the development of hypoglycemia are possible. Such a false positive result can also mask existing hypoglycemia, which means that the patient will not receive appropriate therapy. Thus, when using Octagam В® 10%, as with other parenteral solutions containing maltose, glucose-specific methods for determining blood glucose should be used. Therefore, when studying the instructions for the test kit (including test strips) for determining the concentration of glucose in the blood, particular attention should be paid to the possibility of its use in patients receiving preparations containing maltose.
During the shelf life, it is possible to store the drug at a temperature of up to 25 В° C for 3 months without re-placing in the refrigerator. Unused during this time the drug should be destroyed.
The drug does not have any effect on the ability to drive a car or perform work that requires an increased concentration of attention and a psychomotor reaction.
Symptoms: water retention in the body, increased blood viscosity (especially in patients with impaired renal function or in old age).
The administration of the drug may reduce the effectiveness of live attenuated viral vaccines (against measles, smallpox, rubella, mumps, varicella) for a period of 6 weeks to 3 months. Before vaccination with live attenuated vaccines should be at least 3 months after the drug. In the case of a measles vaccine, this effect can persist for up to 1 year. In this regard, before using measles vaccine it is necessary to check the titre of anticorrosive antibodies.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature of 2 to 8 В° C, in a place protected from light. Do not freeze. Keep out of the reach of children.
Shelf life - 2 years. Do not use after the expiration date stated on the package.