Refers to drugs that increase immunity, "Octagam." The instruction to him reminds that this drug is serious, and it is administered only in a hospital, strictly as prescribed by the doctor. Used in substitution and immunomodulatory treatment.
The form of release of the drug and its composition
The drug “Octagam” is available only in the form of a solution for infusion. The instructions are attached to it and must be studied before use. The solution is transparent, with a yellowish tint. The medicine is made in glass bottles of 20, 50, 100, 200 ml, which are closed with a rubber stopper with aluminum break-in and packed in a cardboard box, where, in addition to the instructions for use, there is a plastic holder net.
The drug contains in 1 ml of at least 95% immunoglobulin G. This indicator is equivalent to the amount of protein that is contained in human blood plasma. Additional substances in the composition of the drug are:
- maltose;
- octoxynol;
- tributyl phosphate;
- water for injection.
The drug should not be frozen and exposed to sunlight. It is stored at a temperature of 2-8 ° C, out of the reach of children.
Pharmacology and pharmacokinetics
The drug "Octagam" (the instruction warns of contraindications and possible consequences of the use of this medicine) affects the human immune system and refers to immunoglobulins.
The medication 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 a reduced level of IgG, leading it to a normal state. IgG molecules did not undergo any changes due to enzymatic and chemical effects. Antibody activity was fully preserved.
The drug “Octagam” includes not more than 3% of polymers, the remaining part falls on dimers and monomers, this is about 90%.
When creating this tool, the blood of 3,500 absolutely healthy donors was used. Antibodies that were present in the plasma of these people remained in this drug unchanged and fully retained activity.
After the drug is injected 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 excreted on the 24-36th day. The half-life for all is different and depends on the age of the patient, the degree of immunodeficiency. Immunoglobulin G and other immune complexes containing this component are destroyed by the reticuloendothelial system.
When is Octagam used?
Octagam is used in substitution therapy when primary immunodeficiency syndromes occur, primarily, congenital hypogammaglobulinemia, agammaglobulinemia, and Wiskott-Aldrich syndrome. This also includes unclassified immunodeficiency of variable type and combined immunodeficiencies.
An indication for the prescription of the drug is myeloma, chronic lymphocytic leukemia. Prescribe the drug for recurrent infections and with a diagnosis of HIV in children.
The medicine has found its application in immunomodulating 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 platelet count. Prescribe medication for Guillain-Barré syndrome. Indication for use is Kawasaki disease in children and adults.
Use "Octagam" (instructions for use describe in detail the method of administration and dosage of the drug) for allogeneic bone marrow transplantation.
Contraindications to infusion
Warns that it is necessary to consider contraindications before using the drug "Octagam", instructions. Do not use the medicine in the presence of hypersensitivity to its constituent substances or to homologous immunoglobulins.
With extreme caution, the drug is prescribed to patients who are obese. They are predisposed to the development of thrombosis. The remedy is contraindicated if there is a "diagnosis of arterial hypertension", diabetes mellitus, pathology of the cardiovascular system, prolonged exposure without movement, increased blood viscosity.
With increased plasma viscosity, immunoglobulin entering the bloodstream provokes a risk of myocardial infarction, pulmonary thromboembolism, stroke, venous thrombosis.
Patients with renal failure, hypovolemia and patients undergoing treatment with nephrotoxic agents should use this drug with caution. If, with the introduction of immunoglobulin, an acute stage of renal failure is observed, then Octagam therapy is discontinued.
In patients with acute renal failure, as well as people with thromboembolic complications, an intravenous injection or dropper 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, in these periods, the drug should be used with extreme caution. Despite this, practice shows that when using immunoglobulins, no negative effects occur during pregnancy. The drug does not affect the fetus and does not affect the infant through mother's milk. Immunoglobulins, falling into breast milk, do no harm to the newborn, and the antibodies contained in it only contribute to the formation of strong immunity.
Dosage and route of administration
The medicine "Octagam" is administered only into a vein. Before starting the procedure, the solution should be warmed to room temperature. The liquid must be completely transparent, without sediment and turbidity.
Each administration of the drug is recorded in the medical history. There also make the series number of the medication and its name. This is done to improve monitoring of the patient's condition. The medicine remaining after the infusion is not subject to storage and must be destroyed.
The initial rate of administration is 0.01-0.02 ml / kg body weight per minute, and so on for half an hour. With good drug tolerance, the speed can gradually be increased to 0.12 ml / kg of weight in one minute.
The amount of medication and 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.
Immunomodulatory replacement 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 a similar indicator, it will take 3-6 months of treatment. The initial dose is 0.4-0.8 g / kg. Subsequently, the drug is administered to patients every three weeks at 0.2 g / kg. To achieve an immunoglobulin index of 6.0 g / l, it is necessary to put 0.2-0.8 g / kg of the drug monthly to the patient. 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 best dosage.
Substitution medication is carried out in case of chronic lymphocytic leukemia, which occurs with severe secondary hypogammaglobulinemia, with myeloma, and also with a diagnosis of HIV positive in children and with recurrent infectious processes. The dosage at the same time fluctuates around 0.2-0.4 g / kg. The frequency of administration is every 3-4 weeks.
During the treatment of acute episodes of idiopathic thrombocytopenic purpura (ITP), a drug is used in a dosage of 0.8-1.0 g / kg when administered on the first day. If necessary, reuse of the drug is performed on the 2nd-5th day, in an 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 in an amount of 2.0 g / kg is allowed. During the treatment, patients should use acetylsalicylic acid simultaneously with the administration of Octagam.
Immunoglobulin is used after allogeneic bone marrow transplantation in preparatory therapy. The introduction of the drug prevents the occurrence of infectious complications and the development of the transplant versus host syndrome. The dosage here for each patient is selected individually. It is recommended to start from a dose of 0.5 g / kg per week. Drug administration procedures should begin one week before the upcoming organ transplant. Therapy is continued for three months after surgery. If there is a permanent deficiency of immunoglobulins, then the medicine is used at 0.5 g / kg every month until their blood content returns to normal.
Side effects
The instructions for use must be studied before use of the drug "Octagam". The development of side effects when using the drug depends on the dose and rate of administration.
An 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 occur, facial swelling, angioedema.
Therapy of HIV in children and the treatment of other diseases often provokes a headache. Rarely enough, there is a violation of the blood circulation of the brain, excessive agitation, aseptic meningitis. The drug can cause migraines, paresthesia, and dizziness.
During treatment, there is a possibility of myocardial infarction. Heart palpitations and tachycradia may be observed. Cyanosis, hypotension and thrombosis are sometimes disturbing. Rarely enough is circulatory failure, deep vein thrombosis, hypertension.
The drug can cause negative reactions from the respiratory system. This is respiratory failure, pulmonary edema, shortness of breath. Negative consequences are expressed in coughing fits, bronchospasm, pulmonary embolism.
Treatment can provoke nausea, vomiting, pain in the abdomen, and diarrhea. In rare cases, eczema, hives, and itching occur. In some patients, dermatitis, alopecia, and skin itching occurred after using the drug.
Reactions such as back pain, myalgia, and arthralgia are rarely observed. Even with treatment, renal failure may develop, creatinine levels may increase, fever, excessive fatigue may disturb, and uncomfortable reactions may occur at the injection site. Common infrequent side effects include chills, chest pain, flushing, general malaise, hyperhidrosis, and hyperthermia. In rare situations, patients experience a decrease in blood pressure, anaphylactic shock.
The occurrence of side effects is also possible in patients who have previously administered the drug well. "Octagam" causes an increase in liver enzymes and glucose concentrations in laboratory blood tests.
With the wrong dose, overdose symptoms may occur. This, as a rule, is 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
The drug is able to reduce the effects of live attenuated viral vaccines for a period of six weeks to three months. To prevent this from happening, you should wait three months after using the drug "Octagam". The medication reduces the effectiveness of the measles vaccine for a year, so before setting this vaccine, the titer of measles antibodies should be checked.
Treatment with this drug can cause a number of side effects, so you should strictly follow the instructions for dosage and speed of administration. During therapy, it is necessary to monitor the patient's well-being at all times.
Patients who are administered immunoglobulins intravenously should receive adequate hydration before the procedure, monitor diuresis and creatinine in the blood. The use of "loop" diuretics should be completely removed.
In the presence of negative reactions, it is necessary to reduce the rate of administration of the drug or completely stop its use. Therapy is completely dependent on the severity and nature of the occurrence of side effects. If shock is observed, then it is necessary to resort to antishock therapy, which should be combined with the treatment.
Very often negative reactions are caused by the fast rate of drug administration, especially with hypo- and agammaglobulinemia and the use of immunoglobulin primarily. Side effects can occur when a patient is transferred from an immunoglobulin from one 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 continuously, throughout the entire period of the first infusion, especially during the first hour after the administration procedure. Patients who do not experience side effects should be under the supervision of a doctor after an infusion of Octagam for the first 20 minutes.
During therapy, standard measures should be taken to prevent infections, which are possible with medications made from human blood or plasma. They include the selection of suitable donors, the control of individual portions and pools of plasma on special markers of infection. This process should include measures to inactivate / eliminate viruses.
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 determining the 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 of treatment with agents containing human immunoglobulin suggests that parvovirus B19 and hepatitis A during therapy these drugs are not transmitted. The presence of appropriate antibodies in the drug is of great importance in antiviral safety.
During the course of the therapeutic course, passively transferred antibodies in the patient's blood can give false results when conducting serological tests. The maltose 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 removal from the body or fifteen hours after its completion. In this case, there is a possibility of inaccurate administration of a dose of insulin, which can provoke hypoglycemia. Therefore, in the treatment with “0ctagam”, only glucose-specific methods for determining blood glucose should be used. Test suites for monitoring blood sugar should be able to determine this parameter in patients taking medications with maltose.
If the expiration date has not expired, then it is allowed to store the medicine “Octagam” (50 ml and 100 ml) at a temperature of up to + 25 ° C for three months, without placing it in the refrigerator again. Unused drug for the specified time is subject to destruction.
The medication does not affect the ability to drive a vehicle and perform actions that require a special concentration of attention and a quick psychomotor reaction.
The drug "Octagam": analogues
This medicine has a number of analogues that can replace it if necessary, this:
- "Biaven V.I."
- Wigam-liquid.
- "Venoglobulin."
- "Gabrilobin."
- "Gabrilobin-IgG."
- "Wigam-S."
- Gamuneks.
- "Gamma Globulin Human."
- "I.G. Vienna N.I. "
- "Imbioglobulin."
- "Immunoglobulin."
- "Imbiogam."
- "Immunovenin."
- "Intratekt."
- Sandoglobulin.
- "Endobulin."
- "Phlebogamma 5%."
- Humaglobin.
Russian substitutes are much cheaper than foreign counterparts. 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. Can be purchased 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
The drug "Octagam" reviews are mostly positive. His qualities are especially appreciated by people whom he helped recover in immunodeficiency conditions and Guillain-Barré syndrome. It is often used by AIDS patients to maintain their health. He has proven effective in chronic lymphocytic leukemia, myasthenia gravis. Women use this medicine to get pregnant and have a baby.
Most patients are unhappy with the cost of the drug, they note that it is difficult to obtain in pharmacies. For some, it caused weakness, headache, and general malaise.
Doctors note that this is the purest drug, it is well absorbed by the body, and, unlike domestic immunoglobulins, causes allergies less often.