Relates to immunity-boosting drugs, Octagam. The instruction to it reminds that this is a serious drug, and it is administered only in a hospital, strictly according to the doctor's prescription. Used in replacement and immunomodulatory treatments.
Medication form and composition
Available only in the form of a solution for infusion, the drug "Octagam". Instructions are attached to it and are subject to mandatory study before use. The solution is clear, with a yellowish tinge. The medicine is produced in glass bottles with a volume of 20, 50, 100, 200 ml, which are closed with a rubber stopper with an aluminum rim and packed in a cardboard box, where, in addition to the instructions for use, there is a plastic mesh holder.
The drug contains at least 95% immunoglobulin G in 1 ml. This indicator is equivalent to the amount of protein contained in human blood plasma. Additional substances in the composition of the drug are:
- m altose;
- octoxynol;
- tributyl phosphate;
- water for injections.
DrugDo not freeze or expose to sunlight. It is stored at a temperature of 2-8 °C, out of the reach of children.
Pharmacology and pharmacokinetics
The Oktagam drug (the instruction warns of contraindications and possible consequences of using this medicine) affects the human immune system and belongs to immunoglobulins.
The drug contains class G immunoglobulins, which produce antibodies to various infectious processes in the body. The drug contains subclasses of immunoglobulin G, identical to human plasma, repeats all its properties and characteristics. The introduction of the drug into the body restores the reduced level of IgG, leads it to a normal state. IgG molecules did not undergo any changes due to enzymatic and chemical effects. Antibody activity was fully preserved.
Octagam contains no more than 3% of polymers, the rest is dimers and monomers, which is about 90%.
When creating this product, the blood of 3500 absolutely he althy donors was used. The antibodies that were present in the plasma of these people remained unchanged in this preparation and retained their full activity.
After the injection of the drug into a vein, immunoglobulin G immediately enters the systemic circulation, where it is distributed between the vascular space and plasma. When using Octagam, the patient's condition improves within 3-5 days. The medicine is withdrawn on the 24-36th day. The half-life is different for everyone and depends on the age of the patient,degree of immunodeficiency. Immunoglobulin G and other immune complexes containing this component are destroyed by the action of the reticuloendothelial system.
When is Octagam used?
Octagam is used in replacement therapy when primary immunodeficiency syndromes occur, primarily congenital hypogammaglobulinemia, agammaglobulinemia and Wiskott-Aldrich syndrome. This also includes unclassified variable immunodeficiency and combined immunodeficiencies.
The indication for the prescription of the drug is myeloma, chronic lymphocytic leukemia. The drug is prescribed for recurrent infections and for the diagnosis of HIV in children.
The drug has found its application in immunomodulatory therapy. That is, it is used for idiopathic thrombocytopenic purpura (ITP), accompanied by an increased risk of bleeding. Also, the drug is used before surgery to normalize the content of platelets. A medication is prescribed for Guillain-Barré syndrome. The indication for the appointment is Kawasaki disease in children and adults.
Use "Octagam" (instruction for use describes in detail the method of taking and dosage of the drug) for allogeneic bone marrow transplantation.
Contraindications for infusions
Warns that contraindications must be taken into account before using the drug "Octagam", instructions. Do not use the medicine in the presence of hypersensitivity to its constituent substances or tohomologous immunoglobulins.
With extreme caution prescribe the drug to patients who are obese. They have a predisposition to the development of thrombosis. The remedy is contraindicated if there is a "diagnosis of arterial hypertension", diabetes mellitus, pathologies of the cardiovascular system, prolonged inactivity, increased blood viscosity.
With increased plasma viscosity, immunoglobulin, entering the bloodstream, provokes the risk of myocardial infarction, pulmonary thromboembolism, stroke, venous thrombosis.
This drug should be used with caution in patients with renal insufficiency, hypovolemia and patients undergoing treatment with nephrotoxic agents. If, with the introduction of immunoglobulin, an acute stage of renal failure is observed, then Octagam therapy is stopped.
In patients with acute renal failure, as well as people with thromboembolic complications, an intravenous injection or drip with a drug is administered very slowly and in minimal quantities.
The effect of the drug on pregnant and lactating women has not been studied, therefore, during these periods, the drug should be used with extreme caution. Despite this, practice shows that when using immunoglobulins, there are no negative effects during pregnancy. The drug does not affect the fetus and does not affect the nursing child through mother's milk. Immunoglobulins, getting into breast milk, do not cause a newbornno harm, and the antibodies contained in it only contribute to the formation of strong immunity.
Dosage and method of administration
The medicine "Octagam" is injected only into a vein. Before starting the procedure, the solution should be warmed to room temperature. The liquid must be completely clear, free of sediment and turbidity.
Each administration of the drug is recorded in the medical history. The serial number of the drug and its name are also entered there. This is done to improve control over the patient's condition. The drug remaining after the infusion is not subject to storage and must be destroyed.
The initial injection rate is 0.01-0.02 ml/kg of body weight per minute, and so on for half an hour. With good tolerance of the drug, the rate can be gradually increased to 0.12 ml / kg of body weight in one minute.
The amount of medication and the duration of therapy are determined individually for each patient. It all depends on the clinical response in a particular patient, his condition and the diagnosis of the disease.
Replacement immunomodulatory therapy for primary immunodeficiencies involves an increase in the amount of immunoglobulin G to 4.0-6.0 g/l, it is measured before each infusion. In order to achieve this indicator, it will take 3-6 months of treatment. The initial dose of administration is 0.4-0.8 g/kg. In the future, the drug is administered to patients every three weeks at a dose of 0.2 g/kg. To achieve an immunoglobulin index of 6.0 g / l, it is necessary to put the patient on a monthly basis0.2-0.8 g/kg of drug. After the patient's condition returns to normal, the drug continues to be administered every 2-4 weeks, after measuring the concentration of immunoglobulin G in the blood. This will help you choose the optimal dosage.
Medicine replacement therapy is carried out for chronic lymphocytic leukemia, which occurs with severe secondary hypogammaglobulinemia, for multiple myeloma, as well as for the diagnosis of "HIV positive" in children and for recurrent infectious processes. The dosage at the same time fluctuates around 0.2-0.4 g / kg. The frequency of administration - every 3-4 weeks.
During the treatment of acute episodes of idiopathic thrombocytopenic purpura (ITP), the drug is used at a dosage of 0.8-1.0 g/kg when administered on the first day. If necessary, reuse of the drug is made on the 2nd-5th day, in the amount of 0.4 g / kg. If cases of exacerbation of the disease are repeated, then the medicine is administered again.
Guillain-Barré syndrome treatment involves 0.4 g/kg of the drug per day for 3-7 days. In this case, the use of the drug for children is very limited.
Kawasaki disease in children and adults is treated with a dosage of 1.6-2.0 g/kg. The drug is administered in the same dose for 2-5 days. A single formulation of the drug is allowed in the amount of 2.0 g/kg. During the ongoing treatment, patients should use acetylsalicylic acid simultaneously with the administration of Octagam.
Immunoglobulin is used after allogeneic bone marrow transplantation in preparatorytherapy. The introduction of the drug prevents the occurrence of infectious complications and the development of the graft-versus-host syndrome. The dosage here for each patient is selected individually. It is recommended to build on a dose of 0.5 g/kg per week. The drug administration procedures should begin one week before the upcoming organ transplant. Therapy is continued for three months after the operation. If there is a persistent lack of immunoglobulins, then the drug is used at 0.5 g / kg every month until their blood levels return to normal.
Side effects
Subject to mandatory study before using the drug "Octagam" instructions for use. The development of side effects when using the drug depends on the dose and rate of administration.
Intravenous injection with this drug can cause leukopenia, hemolysis and reversible hemolytic anemia. During therapy, negative reactions of the immune system are possible, which are expressed in the manifestation of hypersensitivity. In rare cases, anaphylactoid and anaphylactic reactions, swelling of the face, angioedema occur.
HIV therapy in children and treatment of other diseases often provokes headaches. Quite rarely, there is a violation of the blood circulation of the brain, excessive excitement, aseptic meningitis. The drug can cause migraine, paresthesia and dizziness.
During treatment, there is a possibility of myocardial infarction. May experience increased heart rateand tachycardia. Sometimes concerned about cyanosis, hypotension and thrombosis. Quite rarely, there is circulatory failure, deep vein thrombosis, hypertension.
The drug may cause adverse reactions in the respiratory system. This is respiratory failure, pulmonary edema, shortness of breath. Negative consequences are expressed in coughing fits, bronchospasm, pulmonary embolism.
Treatment can cause nausea, gag reflex, abdominal pain, diarrhea. In rare cases, eczema, hives and itching occur. Some patients have experienced dermatitis, alopecia and pruritus after using the drug.
Reactions such as back pain, myalgia and arthralgia are quite rare. Even during treatment, kidney failure may develop, creatinine levels increase, fever, excessive fatigue, and discomfort at the injection site may occur. Among the infrequent side effects are chills, chest pain, flushing, general malaise, hyperhidrosis, and hyperthermia. In rare situations, patients experience a decrease in blood pressure, anaphylactic shock.
The appearance of side effects is also possible in patients who tolerated the earlier administration of the drug well. Octagam causes an increase in liver enzymes and blood glucose concentrations in laboratory blood tests.
With the wrong dose, overdose symptoms may occur. This is, as a rule, fluid retention in the body, an increase in blood viscosity, which is observed in people with kidney disease,and in elderly patients.
In all of the above cases, symptomatic treatment is recommended.
Special Instructions
Drug can reduce exposure to live attenuated virus vaccines for six weeks to three months. To prevent this from happening, you should wait three months after using the Oktagam preparation. The drug reduces the effectiveness of the measles vaccine for a year, so the titer of measles antibodies should be checked before administering the indicated vaccination.
Treatment with this drug can cause a number of side effects, so you should strictly follow the instructions for dosage and rate of administration. During therapy, it is necessary to monitor the patient's well-being at all times.
Patients receiving intravenous immunoglobulins should be adequately hydrated before the procedure, diuresis and blood creatinine should be monitored. The use of "loop" diuretics should be completely eliminated.
If there are negative reactions, you need to reduce the rate of administration of the drug or completely stop using it. Therapy depends entirely on the severity and nature of the occurrence of side effects. If shock is observed, then it is necessary to resort to anti-shock therapy, which should be combined with ongoing treatment.
Very often, negative reactions are caused by the rapid rate of administration of the drug, especially with hypo- and agammaglobulinemia and the use of immunoglobulin initially. Side effects may occur when a patient is switched from immunoglobulin alone.manufacturer to another drug, and also if a lot of time has passed since the last infusion.
Monitoring of such patients (this also includes patients with HIV-positive status) should be carried out constantly, throughout the entire period of the first infusion, especially during the first hour after the injection procedure. Patients who do not experience side effects should be under the supervision of a doctor after Octagam infusions for the first 20 minutes.
During therapy, standard precautions should be taken to prevent infections that are possible with medicines made from human blood or plasma. They include the selection of suitable donors, the control of individual portions and pools of plasma for specific markers of infection. Virus inactivation/elimination measures should be included in this process.
Despite all the precautions in the treatment of such drugs, the possibility of the transfer of pathogens of a number of infections, viruses and other pathogenic microorganisms cannot be ruled out. All of the above measures work in the detection of enveloped viruses of HIV infection, hepatitis B and C. To the least extent, they determine the carriers of parvovirus B19 and hepatitis A. Clinical experience with treatment with agents containing human immunoglobulin suggests that parvovirus B19 and hepatitis A during therapy these drugs are not transmitted. Of great importance in antiviral safety is the presence of appropriate antibodies in the drug.
During the course of the therapeutic course, passively transferred antibodies topatient's blood can give false results when performing serological tests. The m altose contained in the preparation can falsely distort the level of glucose in the blood.
Increased blood glucose concentrations are observed during the period of drug withdrawal from the body or fifteen hours after its completion. In this case, there is a possibility of an inaccurate dose of insulin, which can provoke hypoglycemia. Therefore, in the treatment of "0ktagam" should be used only glucose-specific methods for determining the level of glucose in the blood. Blood sugar monitoring test kits should be able to measure this parameter in patients taking m altose medications.
If the expiration date has not expired, then it is allowed to store the Oktagam medicine (50 ml and 100 ml) at a temperature of up to + 25 ° C for three months, without placing it in the refrigerator again. The drug that has not been used within the specified time is subject to destruction.
The drug does not affect the ability to drive a vehicle and perform activities that require special concentration of attention and a quick psychomotor reaction.
Octagam drug: analogues
This medicine has a number of analogues that can replace it if necessary, these are:
- "Biaven V. I.".
- Wigam Liquid.
- Venoglobulin.
- Gabriglobin.
- Gabriglobin-IgG.
- Wiggum-S.
- Gamunex.
- Gamma Globulin Human.
- "I. G. Vienna N. I. V.”
- "Imbioglobulin".
- "Immunoglobulin".
- "Imbiogam".
- "Immunovenin".
- Intratekt.
- "Sandoglobulin".
- "Endobulin".
- "Phlebogamma 5%".
- "Humaglobin".
Russian substitutes are an order of magnitude cheaper than their foreign analogues. In any case, all these drugs are quite serious, and only a doctor should select a replacement, based on the patient's condition.
Octagam medicine: price
The cost of this drug is quite high. You can buy for 9, 5-12 thousand rubles 50 ml of the drug "Octagam". The price of 100 ml fluctuates around 20-24 thousand rubles.
Opinions of patients and doctors
Octagam drug reviews are mostly positive. His qualities are especially appreciated by people whom he helped to recover from immunodeficiency states and Guillain-Barré syndrome. It is often used by AIDS patients to maintain their he alth. It has proven its effectiveness in chronic lymphocytic leukemia, myasthenia gravis. Women use this medicine to get pregnant and have a baby.
Most of the patients are dissatisfied with the cost of the drug, they note that it is difficult to get it in pharmacies. For some, it caused weakness, headaches and general malaise.
Doctors note that this is the purest drug, it is well absorbed by the body, and, unlike domestic immunoglobulins, rarely causes allergies.
