Octagam^® (Solution) Instructions for Use

ATC Code

J06BA02 (Normal human immunoglobulin for intravenous administration)

Active Substance

Human normal immunoglobulin (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

Immunoglobulin

Pharmacological Action

Human immunoglobulin, by replenishing the deficiency of antibodies, reduces the risk of developing infections in patients with primary and secondary immunodeficiency.

Indications

Congenital immunodeficiency states (congenital complete or partial immunodeficiency, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott-Aldrich syndrome); idiopathic thrombocytopenic purpura (especially acute forms in children).

Acquired immunodeficiency (chronic lymphocytic leukemia, AIDS in children, bone marrow transplantation and other types of transplantation); Kawasaki syndrome (as an adjunct to acetylsalicylic acid therapy); prevention and therapy of infectious diseases.

ICD codes

Dosage Regimen

Administer Octagam^® by intravenous infusion only. Adjust the dose and infusion rate based on the indication, patient’s clinical response, and tolerability.

For primary immunodeficiency syndromes, administer a dose of 300 to 600 mg per kg body weight every 3 to 4 weeks. Initiate therapy with a dose of 400 to 600 mg/kg. Titrate the dose and interval to maintain trough IgG levels of at least 5 to 6 g/L.

For chronic idiopathic thrombocytopenic purpura (ITP), administer a dose of 1 g per kg body weight for 1 to 2 consecutive days. A single 1 g/kg dose or a divided total dose of 1 g/kg over 2 days is acceptable. Monitor platelet count and clinical response to determine the need for further doses.

For Kawasaki disease, administer a single dose of 2 g per kg body weight as an adjunct to acetylsalicylic acid therapy. Infuse this high-dose regimen with particular attention to the patient’s volume status and vital signs.

Initiate the initial infusion rate at 0.3 mg per kg per minute (0.005 ml/kg/min) for the first 30 minutes. If well-tolerated, gradually increase the rate to 1.2 mg per kg per minute (0.02 ml/kg/min), and then to a maximum rate of 3 mg per kg per minute (0.05 ml/kg/min) for subsequent infusions.

Do not exceed the recommended maximum infusion rate. Continuously monitor the patient for adverse reactions during the infusion and for at least 20 minutes after its completion. Pre-medication with analgesics or antihistamines may be considered for patients with a history of adverse reactions.

Adverse Reactions

Headache, chills, increased body temperature, nausea, vomiting, joint pain, back pain, allergic reactions.

Rarely – decreased blood pressure, in isolated cases – anaphylactic shock, symptoms of aseptic meningitis (severe headache, nausea, vomiting, increased body temperature, neck stiffness, photophobia, impaired consciousness), worsening of renal failure in patients with impaired renal function.

Contraindications

Hypersensitivity, IgA deficiency in the presence of antibodies against IgA in the patient.

With caution pregnancy, lactation period.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation (breastfeeding).

Pediatric Use

Use is possible according to indications and in accordance with the dosage regimen.

Special Precautions

A temporary increase in the content of administered antibodies in the patient’s blood after immunoglobulin administration may cause false-positive results in serological tests.

The recommended infusion rate of the drug should not be exceeded (severe adverse reactions may develop). The patient should be under medical supervision throughout the entire infusion period and for 20 minutes after it.

Drug Interactions

Reduces the activity of attenuated live vaccines against measles, rubella, mumps, chickenpox (if administered within the first 2 weeks after vaccination against measles, mumps, and rubella, vaccinations with these vaccines should be repeated no earlier than 3 months later).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.