Gamimun N (Solution) Instructions for Use

Marketing Authorization Holder

Talecris Biotherapeutics Inc. (USA)

ATC Code

J06BA02 (Normal human immunoglobulin for intravenous administration)

Active Substance

Human normal immunoglobulin (Ph.Eur. European Pharmacopoeia)

Dosage Form

Gamimun N

Solution for intravenous administration 10%: fl. 10 ml, 25 ml, 50 ml, 100 ml or 200 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for intravenous administration 10% transparent or slightly opalescent, colorless or pale yellow in color.

10 ml – bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

The drug is an immunologically active protein fraction isolated from the plasma of healthy donors, the selection of whom, as well as the blood collection procedure, is carried out in accordance with WHO recommendations and European requirements.

Individual plasma units used for the production of the drug are tested for the absence of antibodies to human immunodeficiency virus (HIV-1 and HIV-2), hepatitis C virus, and hepatitis B virus surface antigen (HBsAg).

The drug contains 9-11% protein, at least 98% of the protein is gamma-globulin, 90% of which is in the form of a monomer. The distribution of IgG subclasses in the drug is the same as in normal plasma. IgA and IgM are present in trace amounts.

The drug contains complete opsonizing and neutralizing antibodies against pathogens of various infectious diseases.

Pharmacokinetics

Distribution

Within the first 24 hours after intravenous administration, 30% of antibodies from the systemic circulation are distributed in the extracellular spaces.

Elimination

The T_1/2 of antibodies varies depending on individual characteristics and averages 3 weeks.

Indications

• Primary humoral immunodeficiency (congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, X-linked hyper-IgM immunodeficiency, severe combined immunodeficiency);
• Idiopathic thrombocytopenic purpura;
• HIV infection in children;
• Prevention of infections during bone marrow transplantation in patients over 20 years of age.

ICD codes

Dosage Regimen

For primary humoral immunodeficiency, the recommended dose of Gamimun N is 100-200 mg (1-2 ml)/kg of body weight, administered once a month. More frequent administration of the drug or an increase in the dose to 400 mg/kg (4 ml/kg) is possible in case of an inadequate clinical effect or insufficient increase in serum IgG levels.

An increase in platelet count in children and adults with acute and chronic idiopathic thrombocytopenic purpura (ITP) is achieved by using Gamimun N in a single dose of 1000 mg/kg (10 ml/kg), administered once or over two consecutive days. If in the latter case a positive effect is achieved the next day, then the second dose may not be administered. The use of a dose of 1000 mg/kg (10 ml/kg) is not recommended for dehydrated patients.

With both treatment regimens, the effect usually occurs within a few days and lasts for varying periods of time. Treatment is generally more effective in children than in adults.

Maintenance therapy in children and adults is carried out if, after the therapy, the platelet count is less than 30,000/mm³ and/or the patient has visible bleeding, in which case Gamimun N is administered once at a dose of 400 mg/kg (4 ml/kg). Maintenance infusions can be performed at intervals based on clinical indications until a platelet count of more than 30,000/mm³ is achieved.

For bone marrow transplantation, the recommended dose of Gamimun N in persons over 20 years of age is 500 mg/kg (5 ml/kg). The drug is administered 7 and 2 days before transplantation and then weekly for 3 months.

For HIV infection inchildren, the recommended dose of Gamimun N is 400 mg/kg (4 ml/kg). The drug is administered at 28-day intervals.

Rules for drug administration

Gamimun N is administered at a rate of 0.01-0.02 ml/kg body weight/min for at least 30 minutes. If well tolerated, the rate can be increased to a maximum of 0.08 ml/kg/min. If side effects occur, the infusion rate should be reduced or the administration of the drug should be discontinued.

The infusion of Gamimun N should be carried out using a separate system without mixing with other solutions and medications, including other immunoglobulin preparations. If dilution of the drug is necessary, only 5% aqueous dextrose solution should be used.

The stopper should be pierced by directing the needle perpendicular to its surface, in the area bounded by the raised ring.

Adverse Reactions

General reactions rarely – anxiety, flushing, shortness of breath, cramping abdominal pain, myalgia, arthralgia, dizziness, fainting, chills, fever, headache.

Allergic reactions very rarely – rash; in patients with a history of allergic reactions to intramuscular immunoglobulin administration, anaphylactic shock may develop.

These reactions are related to the rate of drug administration, so the recommended infusion rate should be strictly observed.

Other in predisposed patients, the administration of Gamimun N may lead to the development of renal function disorders (including acute renal failure and osmotic nephrosis).

Contraindications

• Anaphylactic or severe systemic reactions to the administration of human immunoglobulin;
• Selective IgA deficiency in the presence of antibodies to IgA.

Use in Pregnancy and Lactation

Since it is unknown whether the administration of Gamimun N during pregnancy has a damaging effect on the fetus, it should be prescribed to pregnant women only in case of absolute necessity.

Use in Renal Impairment

The drug should be administered at the lowest recommended doses and at a rate of less than 8 mg/kg/min (0.08 ml/kg/min) to patients at risk of developing renal failure, including patients with kidney disease, diabetes mellitus, over 65 years of age, with dehydration, with sepsis, receiving concomitant nephrotoxic therapy.

Periodic monitoring of renal function is especially important in patients at increased risk of developing renal failure. Before starting therapy, the functional state of the kidneys should be determined, including the levels of urea and creatinine in the blood. Similar studies are advisable during treatment. If changes in renal function are detected, treatment is discontinued. The patient should be warned about the need to immediately inform the doctor in case of decreased urine output, sudden weight gain, swelling and/or shallow breathing.

Pediatric Use

For HIV infection inchildren, the recommended dose of Gamimun N is 400 mg/kg (4 ml/kg). The drug is administered at 28-day intervals.

Special Precautions

The drug should be administered at the lowest recommended doses and at a rate of less than 8 mg/kg/min (0.08 ml/kg/min) to patients at risk of developing renal failure, including patients with kidney disease, diabetes mellitus, over 65 years of age, with dehydration, with sepsis, receiving concomitant nephrotoxic therapy.

Before starting the administration of the drug, the water balance should be checked to detect patient dehydration.

Periodic monitoring of renal function is especially important in patients at increased risk of developing renal failure. Before starting therapy, the functional state of the kidneys should be determined, including the levels of urea and creatinine in the blood. Similar studies are advisable during treatment. If changes in renal function are detected, treatment is discontinued. The patient should be warned about the need to immediately inform the doctor in case of decreased urine output, sudden weight gain, swelling and/or shallow breathing.

In very rare cases, after intravenous immunoglobulin administration, within a period of several hours to 2 days, aseptic meningitis syndrome develops, characterized by severe headache, neck stiffness, drowsiness, fever, photophobia, pain on eye movement, nausea, vomiting. Cerebrospinal fluid shows pleocytosis (up to several thousand/mm³), predominantly due to granulocytes, and increased protein content. This syndrome usually occurs in patients who have received immunoglobulin in high doses. Upon discontinuation of the drug, complete recovery occurs without any residual effects.

Antibodies contained in Gamimun N may suppress the development of immunity during immunization with measles, mumps, and rubella vaccines, therefore, the latter can be administered no earlier than 6 months after the end of therapy.

Overdose

Cases of Gamimun N overdose have not been described.

Drug Interactions

Drug interactions of Gamimun N have not been described.

Storage Conditions

The drug should be stored and transported at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze.

Shelf Life

Shelf life – 3 years.

After opening the vial, the drug must be used immediately. A partially used vial must be discarded.

Do not use a cloudy solution, or a solution that has been frozen.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.