"Octagam": instructions for use, indications, side effects

Refers to medicines that enhance immunity, "Octagam".The instruction to it reminds that this preparation is serious, and it is introduced only in a hospital environment, strictly according to the doctor's prescription. It is used in the substitution and immunomodulating treatment.

Form of the drug and its composition

Is available only in the form of a solution for infusions drug "Octagam".The instruction to it is attached and must be studied before use. The solution is clear, with a yellowish tinge. The medicine is made in glass bottles with a volume of 20, 50, 100, 200 ml, which are closed by a rubber stopper with aluminum rolling and packed in a cardboard box, in addition to the instructions for use, there is a plastic mesh holder.

The drug contains in 1 ml not less than 95% of immunoglobulin G. This indicator is equivalent to the amount of protein that is contained in the plasma of human blood. Additional substances in the drug are:

• maltose;
• octoxynol;
• tributyl phosphate;
• water for injection.

The preparation should not be frozen and exposed to sunlight. It is stored at a temperature of 2-8 ° C, in a place inaccessible to children.

Pharmacology and pharmacokinetics

The preparation "Octagam"( the instruction warns about contraindications and possible consequences of the use of this medicine) affects the human immune system and refers to immunoglobulins.

The drug has a class G immunoglobulins that produce antibodies to various infectious processes in the body. The drug contains subclasses of immunoglobulin G, identical to human plasma, repeats all of its properties and characteristics. The introduction of the drug into the body restores the lowered level of IgG, leads it to a normal state. IgG molecules did not undergo any changes due to enzymatic and chemical effects. The activity of antibodies was completely preserved.

Octagam contains no more than 3% of polymers, the rest is made up of dimers and monomers, it is about 90%.

The blood of 3,500 absolutely healthy donors used this tool. The antibodies that were present in the plasma of these people remained in this preparation in an unchanged form and completely retained activity.

Once the drug is injected into the vein, the immunoglobulin G immediately enters the systemic circulation, where it is distributed between the vascular space and the plasma. When using "Octagam" the patient's condition improves within 3-5 days. The medicine is dispensed on the 24-36th day. The half-life period 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 do you use Octagam?

Octagam is used in substitution therapy when primary immunodeficiency syndromes occur, primarily congenital hypogammaglobulinemia, agammaglobulinemia and Wiskott-Aldrich syndrome. This includes unclassifiable immunodeficiency of the variable type and combined immunodeficiencies.

The indication for the prescription of the drug is myeloma, lymphatic leukemia in chronic form. Prescribe the drug for relapsing infections and when diagnosed with 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. Prescribe medication for Guillain-Barre syndrome. Indication for the purpose is Kawasaki's disease in children and adults.

Octagam is used( the instructions for use describe in detail the method of taking and dosage of the drug) with an allogeneic bone marrow transplant.

Contraindications to infusions

Warns that contraindications should be considered before applying Octagam, instructions. Do not use the drug in the presence of hypersensitivity to its constituent substances or to homologous immunoglobulins.

With extreme caution, prescribe the drug to patients who are obese. They have a predisposition to the development of thrombosis. The drug is contraindicated if there is a "diagnosis of hypertension," diabetes, cardiovascular disease, prolonged exposure to motion, increased blood viscosity.

With increased plasma viscosity, immunoglobulin, entering the bloodstream, provokes the risk of myocardial infarction, pulmonary thromboembolism, stroke, venous thrombosis.

With caution use this medication should patients with renal insufficiency, hypovolemia and patients undergoing treatment with nephrotoxic agents. If an acute stage of kidney failure is observed with the introduction of an immunoglobulin, then the therapy "Octagam" is stopped.

Patients with renal insufficiency in acute form, as well as people with thromboembolic complications, intravenous injection or dropper with drug are administered very slowly and in minimal amounts.

The effect of the drug on pregnant and lactating women has not been studied, therefore, in these periods, the medication should be used with extreme caution. Despite this, practice shows that when using immunoglobulins, no adverse effects occur during pregnancy. The drug does not affect the fetus and does not affect the infant through the mother's milk. Immunoglobulins, getting into breast milk, do not do any harm to the newborn, and the antibodies contained in it only contribute to the formation of strong immunity.

Dosage and method of application

The drug "Octagam" is injected only into the vein. Before starting the procedure, the solution should be warmed to room temperature. The liquid must be completely transparent, free of sediment and turbidity.

Each drug introduction is fixed in the medical history. The number of the medicinal product series and its name are also introduced there. This is done to improve the monitoring of 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 to 0.02 ml / kg body weight per minute, and so for half an hour. If the drug is well tolerated, the rate can gradually be increased to 0.12 ml / kg of weight per minute.

The amount of medication and the duration of therapy are determined individually for each patient. Everything depends on the clinical response of a particular patient, his condition and diagnosis of the disease.

Substitution immunomodulatory therapy for primary immunodeficiency 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, it takes 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 0.2 g / kg. To achieve an immunoglobulin index of 6.0 g / L, the patient should be given a monthly dose of 0.2-0.8 g / kg of the drug. After the patient's condition returns to normal, the drug continues to be injected every 2-4 weeks, previously measuring the concentration of immunoglobulin G in the blood. This will help to choose the optimal dosage.

Substitution therapy with medication is carried out with chronic lymphocytic leukemia, which occurs with secondary hypogammaglobulinemia in severe form, with myeloma, and with the diagnosis of "HIV positive" in children and in recurrent infectious processes. Dosage in this case varies in the region of 0.2-0.4 g / kg. Multiplicity of administration - every 3-4 weeks.

During the treatment of acute episodes of idiopathic thrombocytopenic purpura( ITP), the drug is administered at a dosage of 0.8-1.0 g / kg when administered on the first day. If necessary, re-use of the medication is carried out on the 2-5th day, in an amount of 0.4 g / kg. If the cases of exacerbation of the disease are repeated, then the medicine is injected again.

Guillain-Barre syndrome treatment involves 0.4 g / kg of drug per day for 3-7 days. In this case, the use of the drug for children is very limited.

Kawasaki's 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 setting of the drug in the amount of 2.0 g / kg is allowed. During the treatment, patients simultaneously with the introduction of "Octagam" should use acetylsalicylic acid.

Immunoglobulin is used after allogeneic bone marrow transplantation in preparatory therapy. The introduction of the medication prevents the occurrence of infectious complications and the development of the "graft versus host" syndrome. Dosage here for each patient is selected individually. It is recommended to repel from a dose of 0.5 g / kg per week. Procedures for the administration of the drug should begin one week before the forthcoming organ transplantation. The therapy is continued for three months after the operation. If there is a permanent deficit of immunoglobulins, then the drug is used at 0.5 g / kg every month until their blood content returns to normal.

Side effects of

It is essential that you read the instructions for use before using Octagam. 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. When therapy is possible, negative reactions of the immune system, which are expressed in the manifestation of hypersensitivity. In rare cases, anaphylactoid and anaphylactic reactions occur, swelling of the face, angioedema.

HIV therapy in children and treatment of other diseases often provokes a headache. Infringement of a blood circulation of a brain, excessive exaltation, an aseptic meningitis is seldom enough is observed. The drug can cause migraine, paresthesia and dizziness.

During treatment, there is a possibility of myocardial infarction. There may be increased heart rate and tahikradia. Sometimes it's cyanosis, hypotension and thrombosis. Rare circulatory insufficiency, deep vein thrombosis, hypertension are rare.

The drug may cause adverse reactions from the respiratory system. This is respiratory failure, swelling of the lung, shortness of breath. Negative consequences are expressed in attacks of cough, bronchospasm, pulmonary embolism.

Treatment can cause nausea, vomiting reflex, abdominal pain, diarrhea. In rare cases, there is eczema, hives and itching. In some patients, after using the drug, dermatitis, alopecia and skin itching occurred.

Reactions such as pain in the back area, myalgia and arthralgia are rare. Even during treatment, renal failure may occur, the level of creatinine may increase, the fever may be disturbed, excessive fatigue may occur, and uncomfortable reactions may occur at the injection site. Among the infrequent side effects, there is a chill, pain in the chest, flushing of the face, general malaise, hyperhidrosis, and hyperthermia. In rare situations, patients have a decrease in blood pressure, anaphylactic shock.

The appearance of side effects is possible in patients who have previously tolerated the administration of the drug well."Octagam" causes an increase in hepatic enzymes and glucose concentration in laboratory blood tests.

If the correct dose is taken, overdose symptoms may occur. This is usually a fluid retention in the body, an increase in the viscosity of the blood, which is observed in people with kidney disease, and in elderly patients.

In all of the above cases, symptomatic treatment is recommended.

Specific instructions

The drug is capable of reducing the impact of live attenuated viral vaccines for a period of six weeks to three months. To avoid this, you should wait after applying the drug "Octagam" three months. The medication reduces the effectiveness of the measles vaccine for a year, so before testing this vaccine should check the titre of anticorrosive antibodies.

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 the therapy, it is necessary to monitor the patient's state of health at all times.

Patients who are administered immunoglobulins intravenously should receive adequate hydration before the procedure, monitor diuresis and creatinine levels in the blood. It is necessary to completely eliminate the use of "loop" diuretics.

In the presence of negative reactions, it is necessary to reduce the speed 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 there is a shock, then it is necessary to resort to anti-shock therapy, which should be combined with the treatment.

Very often, negative reactions cause a rapid injection rate of the drug, especially with hypo- and agammaglobulinemia and the use of immunoglobulin primarily. Side effects can occur when a patient is transferred from one manufacturer's immunoglobulin to another drug, and if much time has elapsed since the last infusion.

Control of such patients( this includes patients with HIV-positive status) should be carried out continuously, throughout the period of the first infusion, especially during the first hour after the procedure of administration. Patients who do not experience side effects should be monitored by the doctor after the infusions of Octagam for the first 20 minutes.

During therapy, standard measures should be taken to prevent infections that are possible with the use of medications made from human blood or plasma. They include the selection of suitable donors, control of individual portions and pools of plasma on special markers of infection. In this process should be included measures to inactivate / eliminate viruses.

Despite all the precautions for the treatment with such drugs, it is impossible to exclude the possibility of transferring pathogens of a number of infections, viruses and other pathogenic microorganisms. All of the above measures work in the determination of enveloped viruses of HIV infection, hepatitis B and C. To the smallest extent, they determine the vectors of parvovirus B19 and Hepatitis A. Clinical experience of treatment with means containing human immunoglobulin suggests that parvovirus B19 and hepatitis A in therapythese drugs are not transmitted. The presence of appropriate antibodies in the drug is of great importance in antiviral safety.

During the passage of the therapeutic course, passively transferred antibodies in the patient's blood can give false results when performing serological tests. Maltose, contained in the drug, is capable of falsely distorting the level of glucose in the blood.

Increased blood glucose levels are observed during the withdrawal of the drug from the body or after 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 use only glucose-specific methods of determining the level of glucose in the blood. Test kits for controlling blood sugar should be able to determine this parameter in patients taking medications with maltose.

If the shelf life has not expired, it is allowed to store the drug "Octagam"( 50 ml and 100 ml) at a temperature of up to + 25 ° C for three months, without re-placing it in the refrigerator. Unused for the specified time the drug is subject to destruction.

The medication does not affect the ability to drive a vehicle and perform actions that require special concentration of attention and a rapid psychomotor reaction.

Preparation "Octagam": analogues of

This medicine has a number of analogues that can replace it if necessary, it is:

• "Biaven VI".
• "Vigam-liquid".
• "Venoglobulin".
• "Gabriglobin".
• "Gabriglobin-IgG".
• "Vigam-S".
• "Gamuneks".
• "Gamma Globulin Human".
• "I.G.Vienna NIV ».
• "Imbioglobulin".
• "Immunoglobulin".
• to the Imbiogam.
• "Immunovinin".
• "Intratekt".
• "Sandoglobulin".
• "Endobulin".
• "Flebogamma 5%".
• "Humaglobin".

Russian substitutes are much cheaper than foreign analogues. In any case, all these drugs are serious enough, and the choice should be replaced only by the doctor, relying on the patient's condition.

Medication "Octagam": the price of

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

The drug "Octagam" reviews are mostly positive. His people especially appreciate his qualities, which he helped to recover with immunodeficiency states and Guillain-Barre syndrome. It is often used by people with AIDS to maintain their health. He proved effective in chronic lymphocytic leukemia, myasthenia gravis. Women use this medicine to become pregnant and endure a child.

Most patients are dissatisfied with the cost of the drug, they note that it is difficult to buy in pharmacies. In some, he caused weakness, headache and general malaise.

Doctors say that this is the most pure drug, it is well absorbed by the body, and unlike domestic immunoglobulins, it causes less allergy.