Octagam
Octagam: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Octagam
ATX code: J06BA02
Active ingredient: normal human immunoglobulin (Immunoglobulin Human Normal)
Producer: Octapharma Pharmazeutika Produktionsges GmbH (Austria)
Description and photo update: 2019-26-08
Octagam is a preparation of normal immunoglobulin (class G), containing a wide range of antibodies to infectious agents of various etiologies, designed to restore the level of immunoglobulin G to a normal level, and has immunomodulatory properties.
Release form and composition
Dosage form - solution for infusion: clear or slightly opalescent liquid from colorless to light yellow (in glass vials of 20, 50, 100 or 200 ml of solution, in a cardboard box 1 vial and instructions for use of Octagam).
Composition of 1 ml solution:
- Active ingredient: plasma protein - 0.05 g (including immunoglobulin G (IgG) not less than 95%);
- Auxiliary components: maltose, octoxynol, tributyl phosphate, water for injection.
Pharmacological properties
Pharmacodynamics
The Octagam consists mainly of class G immunoglobulins, which are antibodies to pathogens of various infections. The distribution of subclasses of immunoglobulin G (IgG) in the preparation corresponds to that in natural plasma, they have all the properties that are characteristic of a healthy person.
Effective doses of Octagam help restore low IgG levels to normal. IgG molecules are not altered due to enzymatic or chemical action. Antibody activity is preserved in full.
Octagam contains no more than 3% of polymers, the content of dimers and monomers is no less than 90%.
Pharmacokinetics
After intravenous administration, the plasma protein immediately enters the systemic circulation. The substance has a relatively rapid distribution between plasma and extravascular space. The time to reach an equilibrium state is 3-5 days.
T 1/2 (half-life) is approximately 26–34 days. In different patients, the T 1/2 value can vary, especially in primary immunodeficiency.
Immunoglobulin and IgG complexes are destroyed by the cells of the reticuloendothelial system.
Indications for use
Octagam is used as a substitution therapy drug for the following conditions / diseases:
- Primary immunodeficiency syndromes: Glanzmann-Rinicker syndrome (alimphocytosis, severe combined immunodeficiency), hereditary hypogammaglobulinemia (congenital agammaglobulinemia), Wiskott-Aldrich syndrome, variable unclassified immunodeficiency;
- Chronic lymphocytic leukemia (CLL) or multiple myeloma complicated by recurrent infections and severe secondary hypogammaglobulinemia;
- Congenital human immunodeficiency virus (HIV) in children, complicated by recurrent infections.
Indications for using Octagam as an immunomodulating drug:
- Idiopathic thrombocytopenic purpura (ITP) or Verlhof's disease in children and adults with a high risk of bleeding or before surgery (to correct the platelet count);
- Acute polyradiculoneuritis (Guillain-Barré syndrome);
- Kawasaki's disease (acute febrile febrile mucocutaneous-lymphatic glandular syndrome);
- Allogeneic bone marrow transplantation.
Contraindications
An absolute contraindication to the use of Octagam is hypersensitivity to its components and hypersensitivity or intolerance to homologous immunoglobulins, especially (extremely rarely) with a deficiency of immunoglobulin A (IgA), if the patient has antibodies to IgA.
The clinical experience of therapy with immunoglobulin preparations proves that their use does not have a significant negative effect on the course of pregnancy, fetal development and the condition of the newborn. But since the safety of using Octagam in pregnant women has not been confirmed in the course of controlled clinical trials, the drug is prescribed with caution during pregnancy and lactation (breastfeeding).
In infants, the simultaneous use of Octagam with calcium gluconate is contraindicated.
Octagam, instructions for use: method and dosage
Octagam is administered intravenously.
The following rules must be observed for the administration of the Octagam:
- Register the name of the drug and the batch number in the medical file or medical history, so that it is possible to track the relationship of the patient's condition with the administration of a solution from a specific batch;
- Check the solution for sediment and turbidity; it should be transparent, slightly opalescent or colorless (it is forbidden to use sediment and cloudy solutions);
- Bring the solution temperature to room temperature;
- Use for infusion an initial rate of 0.01-0.02 ml per kg of body weight per minute for at least 30 minutes; if the drug is well tolerated, the rate can be gradually increased, to a maximum of 0.12 ml per kg of body weight per minute;
- The drug remaining after the infusion (in any amount) must be destroyed.
The dosage regimen of Octagam and the duration of the course of therapy are individually selected by the attending physician, depending on the indications, clinical response and pharmacokinetic data of a particular patient.
Recommended dosage:
- Replacement therapy of primary immunodeficiency syndromes: an initial dose of 0.4-0.8 g / kg of body weight with further administration of 0.2 g / kg once every 3 weeks; to achieve a concentration of 6 g / l, a monthly dose of 0.2-0.8 g / kg is required; upon reaching an equilibrium state, it is required to maintain an interval between infusions of 2-4 weeks. To correct the dosing regimen, it is necessary to measure the IgG concentration before each next infusion (the Octagam administration regimen must ensure that the IgG concentration measured before each subsequent infusion is at least within 4-6 g / l, which is achieved within 3-6 months from the start of therapy);
- Replacement therapy for multiple myeloma and complicated recurrent CLL infections with secondary hypogammaglobulinemia and congenital HIV infection in children: 0.2-0.4 g / kg every 3-4 weeks;
- Immunomodulatory therapy of ITP: acute episodes - 0.8-1 g / kg on the first day, if necessary - repeated administration at the same dose on the third day, or for 2-5 days at 0.4 g / kg; in case of relapses, therapy is repeated;
- Immunomodulatory therapy for Guillain-Barré syndrome (acute polyradiculoneuritis): 0.4 g / kg per day for 3-7 days; limited experience of use in pediatric practice;
- Immunomodulatory therapy for Kawasaki disease: 1.6-2 g / kg is administered in equal doses, divided over 2-5 days, or a single administration of 2 g / kg of body weight is performed; simultaneous administration of acetylsalicylic acid is recommended;
- Allogeneic bone marrow transplantation (Octagam is used as one of the components of preparatory therapy against infectious complications and after transplantation to prevent the development of the graft-versus-host syndrome): the doses are selected individually, the recommended initial dose is 0.5 g / kg per week; 1 week before transplantation, course duration - 3 months after transplantation; with a constant deficiency of immunoglobulins, 0.5 g / kg should be administered once a month until the level of immunoglobulins normalizes.
Side effects
- Hematopoietic system: in isolated cases - hemolysis, transient hemolytic anemia;
- Digestive system: vomiting, nausea;
- Urinary system: hypercreatininemia, acute renal failure (especially in patients over 65 years of age, patients with a history of renal failure, obesity, hypovolemia, diabetes mellitus, concomitant therapy with nephrotoxic drugs);
- Cardiovascular system: lowering blood pressure; rarely, collapse; in elderly patients, with severe hypovolemia, ischemia of the heart or brain, obesity, occlusive vascular disease, increased plasma viscosity (for example, against the background of hyperfibrinogenemia, hypergammaglobulinemia, sickle cell anemia) - thromboembolic complications and / or transient ischemic attacks;
- Flu-like syndrome: hyperthermia, headache, chills;
- Allergic reactions: itching, skin rash; rarely - anaphylactic shock;
- Others: arthralgia, back pain and back pain; in isolated cases - reversible aseptic meningitis; in patients with diabetes mellitus - hyperglycemia.
If side effects appear, you need to reduce the rate of administration of Octagam or stop the infusion.
Overdose
Symptoms of an Octagam overdose are an increase in blood density, especially in elderly patients or patients with impaired renal function, as well as water retention in the body. In case of overdose, symptomatic therapy is recommended.
special instructions
During the injection of IgG Octagam, it is required to monitor the patient's condition.
Patients receiving intravenous immunoglobulins should be adequately hydrated before starting the infusion, control urine output and serum creatinine levels, and exclude diuretics acting on the renal tubules.
The administration of high doses of immunoglobulin can increase the viscosity of blood plasma, which increases the risk of thromboembolic complications and ischemia. Most often, adverse reactions occur at a high rate of administration, with agamma and hypoglobulinemia (with or without IgA deficiency), with the initial administration of immunoglobulin or, occasionally, when switching to other immunoglobulins, as well as after a long break since the last infusion.
The first infusion should be carried out slowly, the infusion rate should not exceed 0.016 ml / kg / min. More careful observation is necessary for patients who have not previously received immunoglobulin preparations, received treatment with alternative drugs, or with a long break since the last immunoglobulin infusion. These patients need to be monitored throughout the first injection and within an hour after its end. It is enough to observe the rest of patients in the first 20 minutes of infusion.
A transient increase in the blood of passively transferred antibodies can be the cause of false-positive serological test results.
Passive transfer of antibodies to erythrocyte antigens, for example, A, B or D, can lead to falsification of the results of some serological tests with erythrocyte allo-antibodies (for example, Coombs' test), affect the amount of haptoglobin and reticulocytes.
The content of maltose in the Octagam solution can affect laboratory indicators of the amount of glucose in the blood and urine.
When using drugs from human blood or plasma, the possibility of infection with various pathogens, including previously unknown ones, cannot be completely excluded.
During the production of IgG Octagam, the following measures are observed, which are aimed at eliminating the transfer of viruses by transfusion media:
- Healthy donors are selected, each portion of plasma and plasma pool is tested for antibodies to HIV 1 and 2, hepatitis B virus antigen, hepatitis C;
- Plasma fractions are analyzed for hepatitis C virus genetic material;
- The manufacturing process of the drug includes special procedures for the removal / inactivation of viruses using a solvent / detergent purification system, the effectiveness of which has been confirmed by tests on a viral model.
These measures are effective in removing / inactivating HIV and hepatitis B and C viruses, but may have limited effects on non-enveloped viruses such as hepatitis A and parvovirus B19.
Application during pregnancy and lactation
Octagam during pregnancy / lactation should be used under medical supervision.
Pediatric use
In infants, the combined use of Octagam with calcium gluconate is contraindicated.
Drug interactions
Octagam can reduce the effectiveness of live vaccines of attenuated strains of viruses of the following diseases by 1.5-3 months: measles, smallpox, rubella, mumps, chickenpox. Therefore, a break of at least 3 months should be maintained between the use of the drug and the vaccination with live attenuated vaccines. For measles vaccine, this effect can last up to 1 year, so a measles antibody titer test is required before measles vaccination.
Analogs
Octagam analogues are: Gamimun N, Imbioglobulin, Gamunex, Imbiogam, Endobulin, Immunovenin, Intratect, Prividzhen, Gabriglobin, Intraglobin, Human immunoglobulin normal for intravenous administration, liquid, Phlebogamma 5%, Humaglobulin, Endoglobulin.
Terms and conditions of storage
Keep out of reach of children in a dark place at a temperature of 2-25 ° C. Do not freeze!
Shelf life:
- Vials 20 ml - 1.5 years;
- Bottles of 50, 100 and 200 ml - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Octagama
Reviews of the Octagama testify to its effectiveness. However, users often indicate the development of pronounced side effects, manifested in the form of dizziness, weakness and drowsiness. The cost of the drug is estimated to be high.
Price for Octagam in pharmacies
The approximate price for Octagam (solution for infusion) for 1 bottle is: 50 ml - 9870-11370 rubles, 100 ml - 19 740-23 597 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
