Description
Latin name
Octagam
Release form
Infusion solution is clear or slightly opalescent, colorless to light yellow.
Packaging
100 ml – bottles (1) – packs of cardboard.
Pharmacological action
Octagam ® 10% is a normal immunoglobulin solution (class G) with a wide range of antibodies to pathogens of various infections. The drug is made from a pooled plasma obtained from at least 3,500 donors and contains antibodies present in the plasma of healthy people. Molecules of immunoglobulin G are not subject to change due to chemical or enzymatic effects, the activity of antibodies is fully 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 level. The drug has immunomodulatory properties.
Indications
1. Substitution therapy.
Primary immunodeficiency syndromes:
congenital agammaglobulinemia and hypogammaglobulinemia
unclassifiable variable immunodeficiency
severe combined immunodeficiency
syndrome viscid-oldrichloioma lemogloid lymphoma
Congenital HIV infection with recurrent infections in children.
2. Immunomodulating therapy.
Idiopathic thrombocytopenic purpura (ITP) in adults and children with a high risk of bleeding or before surgery to correct platelet count.
Guillain-Barr © Syndrome.
Kawasaki disease.
3. Allogeneic bone marrow transplantation.
Contraindications
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.
Caution. Caution should be exercised when prescribing the drug to patients with obesity, as well as patients with predisposing risk factors for thrombotic complications, such as: old age, arterial hypertension, diabetes mellitus, vascular system diseases, tendency to develop thrombosis, prolonged standing still, severe hypovolemia diseases accompanied by increased blood viscosity. This is due to the relative increase in blood viscosity when immunoglobulin enters the bloodstream, which increases the risk of developing myocardial infarction, stroke, pulmonary embolism and deep venous thrombosis.
Due to the possible development of acute renal failure, caution should be exercised when administering immunoglobulin intravenously to patients with renal failure, diabetes mellitus, overweight, hypovolemia, elderly patients (over 65 years old), as well as patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, the drug is immediately discontinued.
In patients at risk of developing acute renal failure and thromboembolic complications, the drug is administered at a minimal rate and in minimal doses.
Use in cases of impaired renal function
Because of the possible development of acute renal failure, caution should be exercised when administering immunoglobulin intravenously to patients with renal failure, as well as patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, the drug is immediately discontinued.
In patients at risk of developing acute renal failure and thromboembolic complications, the drug is administered at a minimal rate and in minimal doses.
Use in elderly patients
Caution should be exercised when administering the drug to patients with predisposing risk factors for thrombotic complications, such as, for example, old age.
Due to the possible development of acute renal failure, caution should be exercised when administering immunoglobulin intravenously to elderly patients (over 65 years old), as well as patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, the drug is immediately discontinued.
Use in pregnancy and lactation
The safety of the drug in pregnant women has not been established during controlled clinical trials. In this regard, pregnant and lactating women, the drug should be prescribed with caution. At the same time, clinical experience with 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 the newborn.
Composition of
1 ml of solution contains: plasma protein 100 mg incl. IgG not less than 95%
Excipients: maltose, tributyl phosphate, octoxynol, d / i water.
Dosage and administration
The drug is administered iv. Before the introduction, the temperature of the solution should be brought to room temperature. The solution should be clear or slightly opalescent. It is forbidden to use muddy and sedimentary solutions.
Each time a drug is administered, it is recommended that its name and series number be recorded in the patient s history or medical record so that the patient s condition can be traced to the administration of a particular series of drugs. Any amount of drug remaining after infusion should be destroyed. The initial injection rate is from 0.01 to 0. 02 ml / kg body weight per minute for 30 minutes 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.
Dosing 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 regimen of administration of the drug should ensure that the concentration of immunoglobulin G, measured before each subsequent infusion, reaches at least 4.0-6.0 g / l. From the start of treatment, 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, ranges from 0.2 to 0.8 g / kg of body weight per month. The interval between administrations after reaching equilibrium 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.
Replacement therapy for myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent 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 body weight on the first day, with repeated administration, if necessary, on the third day or 0.4 g / kg body weight per day, for 2- 5 days. Treatment can be repeated in case of a repeated episode.
Guillain-Barré syndrome
0.4 g / kg body weight per day, for 3-7 days. Experience with children is limited.
Kawasaki disease
1.6-2.0 g / kg body weight is administered in equal doses for 2-5 days or once at a dose of 2.0 g / kg body weight. Patients should take acetylsalicylic acid at the same time.
Allogeneic bone marrow transplantation
Immunoglobulin is used as a component of preparatory therapy, as well as after transplantation. When treating infectious complications and to prevent the development of the graft versus host syndrome, the doses of the drug are selected individually. The recommended starting 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 constant deficiency of immunoglobulins, it is recommended to administer 0.5 g / kg of body weight monthly until the level of immunoglobulins is normalized.
Side effects
With the on / 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.
The frequency of adverse reactions is classified as follows: often ( 1% –
from the blood 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, swelling of the face.
From the nervous system: often – headache is very rare – agitation, cerebrovascular accident (including stroke), aseptic meningitis, migraine, dizziness, paresthesia.
From the cardiovascular system: very rarely – myocardial infarction, tachycardia, palpitations, cyanosis, thrombosis, circulatory failure, hypotension, hypertension, deep vein thrombosis.
From the respiratory system: very rarely – respiratory failure, pulmonary embolism, pulmonary edema, bronchospasm, shortness of breath, cough.
From the gastrointestinal tract: often – nausea is very rare – vomiting, diarrhea, abdominal pain.
From the skin: infrequently – eczema is very rare – urticaria, rash (including erythematous), dermatitis, pruritus, alopecia.
From the musculoskeletal system: infrequently – back pain is very rare – arthralgia, myalgia.
From the urinary system: very rarely – acute renal failure, increased creatinine concentration in the blood.
On the part of laboratory indicators: very rarely – an increase in the values of liver enzymes, a false-positive increase in the concentration of glucose in the blood.
Other: often – fever, fatigue, reactions at the injection site are uncommon chills, chest pain is very rare – flushing, hyperthermia, hyperhidrosis, malaise. Rarely, a sudden decrease in blood pressure, and in some cases anaphylactic shock, can develop, including in patients who previously tolerated the administration of immunoglobulin.
Drug Interaction
Administration of the drug may reduce the effectiveness of live attenuated viral vaccines (measles, measles, rubella, mumps, varicella) for a period of 6 weeks to 3 months. Live attenuated vaccines must be given at least 3 months after the administration of the vaccine. In the case of measles vaccine, this effect can persist for up to 1 year. In this regard, the titer of anticancer antibodies should be checked before using the measles vaccine.
Overdose
Symptoms: water retention in the body, increased blood viscosity (especially in patients with impaired renal function or in the elderly).
Treatment: symptomatic.
Storage conditions
Store the drug at a temperature of 2 to 8 ° C, in a dark place. Do not freeze. Keep out of the reach of children.
Expiration
2 years.
Deystvuyuschee substances
immunoglobulin man Normal
dosage form
dosage form
solution infusion
