Gamunex
Gamunex: 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. In case of impaired renal function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Gamunex
ATX code: J06BA02
Active ingredient: normal human immunoglobulin (Immunoglobulin human normal)
Manufacturer: Talekris Biotherapeutic, Inc. (Talecris Biotherapeutics, Inc.) (USA)
Description and photo update: 2019-11-07
Gamunex is a medical immunobiological preparation, normal human immunoglobulin for parenteral use.
Release form and composition
The drug is available in the form of a 10% solution for infusion: colorless or light yellow liquid, from transparent to slightly opalescent (10, 25, 50, 100 or 200 ml each in glass bottles of colorless glass, in a cardboard box 1 bottle and instructions for use Gamunex).
1 ml of solution contains:
- active substance: normal human immunoglobulin - 100 mg (buffer capacity - 35 mEq / l; pH (acidity) - 4-4.5; theoretical osmolality - 258 mosmol / kg);
- auxiliary components: glycine, water for injection.
Pharmacological properties
Pharmacodynamics
Gamunex is an immunological preparation in the form of a solution for intravenous (IV) administration, has immunomodulatory properties. Its active substance is normal human immunoglobulin, treated with caprylate and chromatographically purified. The drug is made from a pool of blood plasma from healthy donors, each individual portion of plasma is monitored for the absence of antibodies to the hepatitis C virus, hepatitis B surface antigen (HBsAg), and human immunodeficiency virus (HIV-1 and HIV-2).
Gamunex contains 9-11% of protein, of which at least 98% have electrophoretic mobility of gamma globulin, trace amounts of fragments of immunoglobulin A (IgA). Immunoglobulin M (IgM) levels are within or below quantification. The distribution of all four subclasses of immunoglobulin G (IgG) is similar to that in normal serum.
The therapeutic effect against pathogens of various infectious diseases is provided by the content in the preparation of high-grade opsonizing and neutralizing antibodies. Gamunex has an immunomodulatory effect.
The solution contains no preservatives.
Pharmacokinetics
There are no data on the pharmacokinetics of human immunoglobulin.
Indications for use
The use of Gamunex is indicated for primary humoral immunodeficiency (general variable immunodeficiency, severe combined immunodeficiency, congenital agammaglobulinemia, X-linked immunodeficiency with IgM overproduction, Wiskott-Aldrich syndrome) and idiopathic thrombocytopenic.
Contraindications
Absolute:
- impaired renal function;
- period of pregnancy;
- breast-feeding;
- severe systemic or anaphylactic reactions to the administration of human immunoglobulin.
Exceptional caution should be exercised when prescribing Gamunex for the treatment of severe selective IgA deficiency (serum IgA less than 0.05 g / l) in patients with antibodies to IgA (due to an increased risk of developing an immediate hypersensitivity reaction, including anaphylaxis).
In addition, it is necessary to use Gamunex with caution in patients predisposed to acute renal failure, risk factors for its development include: a history of renal failure of any severity, diabetes mellitus, decreased urine output, paraproteinemia, sepsis, age over 65, simultaneous the use of nephrotoxic agents.
Gamunex, instructions for use: method and dosage
Gamunex is intended for drip IV administration using a separate infusion system.
Do not mix the solution with other liquids or medications.
Before use, the contents of the bottle must be visually checked for turbidity or discoloration, foreign particles. If the solution is cloudy or frozen, it should be disposed of.
When taking the drug from the bottle for piercing the cork, it is recommended to use a certain needle size: bottles containing 10 ml of solution - 18 mm, 25 ml and more - 16 mm (or distributing punches). The needle should enter the plug only inside the designated circle and strictly perpendicular to the plane.
The connection of the contents of the vials should be carried out under aseptic conditions in sterile bags and used within 8 hours. The infusion rate during the first 0.5 hour should not exceed 0.01 ml (1 mg) per 1 kg of patient weight per minute (ml / kg / min). Then, with a sufficiently good tolerance, it can be gradually increased. The maximum injection rate is 0.08 ml / kg / min. If there is a side effect, the rate of administration should be reduced or interrupted until the symptoms disappear. When the infusion is resumed, the rate should be optimal for the patient.
It is necessary to open the bottle with Gamunex solution immediately before the infusion.
The rest of the unused solution must be disposed of.
The dose and the interval between infusions are prescribed by the doctor, taking into account the individual clinical picture.
Recommended dosage of Gamunex:
- primary humoral immunodeficiency: 300-600 mg per 1 kg of patient weight (3-6 ml / kg) with an interval of 21 or 28 days;
- idiopathic thrombocytopenic purpura: the total dose is 2000 mg / kg. It is divided into 2 infusions of 1000 mg / kg (10 ml / kg), which are administered sequentially in 2 days. If, after 24 hours, the blood test results confirm a sufficient increase in platelet count after the first dose of 1000 mg / kg, then the second dose can be omitted. The use of the drug in a dose of 1000 mg / kg (10 ml / kg) in patients with dehydration is not recommended. The total dose can be divided into 5 doses of 400 mg / kg (4 ml / kg) and administered sequentially for 5 days.
Shown is the use of Gamunex in bone marrow transplantation in patients over the age of 20 years. The drug should be administered 7 and 2 days before transplantation, then once every 7 days for 90 days after transplantation. The recommended single dose is 5 ml / kg (500 mg / kg).
When treating patients with an increased risk of impaired renal function, the infusion rate should not exceed 0.08 ml / kg / min. The dose, concentration and rate of administration of the solution for this category of patients should be at the lower level of the usual indicators.
Side effects
With the introduction of the Gamunex solution from the systems and organs, the same side reactions can be observed as after parenteral administration of other preparations of normal human immunoglobulin:
- from the digestive system: abdominal pain, vomiting, nausea;
- from the immune system: allergic reactions (urticaria, in very rare cases - a rash), anaphylactic reactions;
- from the central nervous system: dizziness, fainting, anxiety;
- from the musculoskeletal system: arthralgia, myalgia;
- from the body as a whole: fever, chills, hot flashes, shortness of breath, headache.
These reactions demonstrate a direct relationship with the rate of introduction of the solution, and therefore it is required to strictly follow all recommendations for the use of Gamunex.
From the urinary system, in the presence of a predisposition, the development of renal failure is possible.
In addition, it is possible to develop adverse reactions that were not detected after the administration of Gamunex, but were previously observed with the intramuscular administration of other human immunoglobulin preparations: in rare cases - cyanosis, bronchospasm, liver dysfunction, pulmonary edema, hypoxemia, convulsions, thromboembolism, dyspnea, hypotension, tremor, pyrexia, hemolysis), back and abdominal pain, positive results of a direct antiglobulin test (Coombs').
In rare cases, there have been reports of the development of aseptic meningitis syndrome with intravenous administration of normal human immunoglobulin. Usually developing a few hours (up to a maximum of two days) after infusion and manifested by stiff neck muscles, severe headache, fever, drowsiness, painful sensations when moving the eyeballs, photophobia, nausea and vomiting. More often this syndrome was observed with the use of high doses of Gamunex (up to 2 g / kg) and / or as a result of intravenous administration of the solution at a high rate. When the infusion of immunoglobulin is stopped in a few days, the aseptic meningitis syndrome regresses without consequences for the patient's health.
Typical anaphylactic reactions to the administration of the solution can be observed in patients with a history, aggravated by severe allergic reactions to i / m administration of IgG. Moreover, in some cases, if you introduce Gamunex with special care, they may not occur. It is extremely rare that anaphylactic reactions can develop in persons with no history of allergic reactions to parenteral administration of immunoglobulins.
Overdose
Overdose symptoms have not been established.
special instructions
There were reports of the development of impaired renal function, acute renal failure, osmotic nephrosis and death due to intravenous administration of human immunoglobulin. Therefore, in patients with an increased risk of developing acute renal failure, the minimum concentration and rate of intravenous administration of immunoglobulin should be used.
With the introduction of Gamunex, one should take into account the likelihood of developing adverse reactions similar to those that occur after intramuscular (i / m) and i / v administration of other human immunoglobulin preparations.
The intravenous administration of Gamunex solution should be performed only with anti-shock therapy agents, including epinephrine (adrenaline). This is due to the fact that in rare cases, the drug can cause a pronounced decrease in blood pressure and the development of an anaphylactic reaction, including in patients with previously good tolerance.
Before starting treatment, it is necessary to conduct a thorough examination of renal function, including measurement of serum creatinine and blood urea nitrogen, to ensure that the patient does not have a reduced urine output. Such monitoring should be carried out at regular intervals throughout the entire period of therapy, especially in patients with an increased risk of developing acute renal failure. If renal dysfunction is established, further use of Gamunex should be discontinued.
Application during pregnancy and lactation
The use of Gamunex is contraindicated during gestation and lactation.
No security information available.
Pediatric use
There are no results from clinical trials of Gamunex in children infected with HIV.
With impaired renal function
The appointment of Gamunex is contraindicated in case of impaired renal function.
The drug should be used with caution in patients predisposed to the development of acute renal failure. Their treatment should be carried out at a dose of less than 8 mg per 1 kg per minute (0.08 ml / kg / min) and accompanied by careful monitoring of renal function and urine output.
Drug interactions
Gamunex is incompatible with saline solutions; only 5% aqueous sucrose solution can be used for dilution.
The interaction of Gamunex when combined with other drugs has not been established.
Analogs
Gamunex analogs are Gamimun, Gabriglobin (Normal human immunoglobulin), Gabriglobin-IgG, Imbioglobulin, Immunovenin, Sigardis Immunoglobulin, Sigardis MT Immunoglobulin, Normal Human Immunoglobulin, Intraglobin, Intratenta, Oktabamogiovigle
Terms and conditions of storage
Keep out of the reach of children.
Store and transport at temperatures between 2 and 8 ° C, do not freeze.
The shelf life is 3 years.
The solution can be stored at temperatures up to 25 ° C for six months for any length of its shelf life, provided that it is then immediately used or disposed of. When removing the bottle from the refrigerator, the date of withdrawal must be recorded in the appropriate column of the outer packaging.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Gamunex
There are currently no patient reviews about Gamunex.
Doctors emphasize that drug treatment should be carried out only in a hospital setting. Infusion should be done by qualified medical personnel, be sure to take into account all recommendations on the dosage regimen and features of the use of Gamunex. Patients receiving the drug need to be under the supervision of personnel in order to receive timely qualified assistance to prevent or reduce the risk of complications.
Price for Gamunex in pharmacies
The price of Gamunex for a package containing 1 bottle of 25 ml solution can, on average, be 11 463 rubles, 50 ml - from 19 325 rubles, 100 ml - from 35 707 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!
