Antihep (Solution) Instructions for Use

ATC Code

J06BB04 (Human hepatitis B immunoglobulin)

Active Substance

Human hepatitis B immunoglobulin

Human hepatitis B immunoglobulin (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

Immunoglobulin

Pharmacological Action

Immunological agent. The active principle consists of antibodies to the surface antigen of the hepatitis B virus.

Antibodies block virus receptors and thereby reduce the risk of developing an infection.

Pharmacokinetics

After intramuscular administration, the C_max of antibodies in the blood is reached after 24 hours. The T_1/2 of antibodies is 4-5 weeks.

With intravenous infusion, the bioavailability is 100%. Distribution between plasma and extravascular fluid occurs quite quickly; the T_1/2 averages 22 days. Immunoglobulin G and IgG complexes are utilized by the cells of the reticuloendothelial system.

Indications

For intramuscular administration: emergency prophylaxis of hepatitis B in children and adults; treatment of mild and moderate forms of acute viral hepatitis B in adults.

For infusions: immunoprophylaxis of hepatitis B in newborns born to mothers who are carriers of the hepatitis B virus surface antigen; immunoprophylaxis of hepatitis B in patients not vaccinated against hepatitis B or without documented confirmation of vaccinations who have been exposed to the risk of hepatitis B virus infection due to contact with material suspected of being infected (for example, in case of a break in the skin from an injection needle prick or direct contact with the mucous membrane); individuals with a tendency to bleeding who require immediate prophylaxis of hepatitis B, since the intramuscular administration of drugs can lead to local hemorrhages; patients with an increased risk of hepatitis B virus infection before or simultaneously with vaccination against hepatitis B (before surgery, repeated blood transfusion, hemodialysis, etc.); prevention of reinfection with the hepatitis B virus in patients after liver transplantation due to liver failure induced by the hepatitis B virus; patients who do not show an immune response (lack of a sufficient amount of antibodies to hepatitis B) after vaccination and who require constant prophylaxis due to the ongoing risk of hepatitis B virus infection.

ICD codes

Dosage Regimen

Administer intramuscularly or as an intravenous infusion. Determine the dose, route, and regimen individually based on indication and patient age.

For post-exposure prophylaxis in adults and children, administer a single dose of 0.05-0.1 ml per kg body weight intramuscularly. Administer the dose as soon as possible, preferably within 24-48 hours after exposure.

For newborns born to HBsAg-positive mothers, administer 0.5 ml (100 IU) intramuscularly immediately after birth, concurrently with the first dose of hepatitis B vaccine at a separate injection site.

For treatment of mild to moderate acute hepatitis B in adults, administer 0.1-0.15 ml per kg body weight intramuscularly daily for 3-5 days, followed by the same dose every other day for 5-7 days.

Use the intravenous route for patients with bleeding disorders to avoid hematoma or for other clinical indications requiring systemic administration. For IV infusion, use a 5% glucose solution as a diluent. Administer at an initial rate of 0.5-1 ml per minute for 30 minutes. If well-tolerated, increase the rate to a maximum of 2-3 ml per minute.

For patients undergoing liver transplantation for HBV-induced liver failure to prevent reinfection, administer high doses intravenously. The regimen is determined individually based on pre-transplant viral load and antibody titers.

For non-responders to vaccination who require ongoing protection, administer a single intramuscular dose of 0.05-0.1 ml per kg every 2-4 months, depending on the persistence of the risk of exposure.

Do not exceed the recommended volume per injection site for intramuscular administration. For adults, use the upper outer quadrant of the gluteal muscle or the deltoid muscle. For children, use the anterolateral thigh muscle.

Adverse Reactions

From the immune system: rarely – hypersensitivity reactions; very rarely – anaphylactic shock.

From the nervous system: rarely – headache.

From the cardiovascular system: rarely – tachycardia, arterial hypotension.

From the digestive system: rarely – nausea, vomiting.

From the skin and subcutaneous tissues: rarely – skin reactions, skin hyperemia, erythema, itching, pruritus.

From the musculoskeletal system: very rarely – arthralgia.

General reactions: rarely – elevated temperature, malaise, chills.

Contraindications

Hypersensitivity to human immunoglobulin and other blood products, especially in rare cases of immunoglobulin class A (IgA) deficiency in the blood and the presence of antibodies against IgA.

Use in Pregnancy and Lactation

During pregnancy, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If use during breastfeeding is necessary, a doctor should be consulted.

Use in Hepatic Impairment

Used according to indications in recommended doses and regimens.

Pediatric Use

Can be used in children according to indications in recommended doses, regimens, and dosage forms.

Special Precautions

In patients not vaccinated against hepatitis B or without documented confirmation of vaccinations who have been exposed to the risk of hepatitis B virus infection due to contact with material suspected of being infected, the administration of immunoglobulin is recommended simultaneously with vaccination against hepatitis B (simultaneous active and passive immunization). Vaccination started in this way should be continued in accordance with the instructions for use of the vaccine.

The administration of immunoglobulin is not indicated if the patient exposed to the risk of hepatitis B virus infection was vaccinated according to the full schedule and has developed a sufficient amount of antibodies (minimum 10 IU/l of serum). If the amount of antibodies to the HBs antigen cannot be determined within 24 hours after contact with contaminated material, then combined prophylaxis (vaccine and immunoglobulin) is necessary in any case.

In case of a history of clinically pronounced allergic reactions, the administration of antihistamines is recommended on the day of immunoglobulin administration and for the subsequent 3 days. Individuals with immunopathological systemic diseases (blood diseases, connective tissue diseases, nephritis, etc.) should receive immunoglobulin against the background of appropriate therapy.

Rooms where immunization is carried out must have medications for anti-shock measures and management of an anaphylactic reaction. After the administration of immunoglobulin, the patient should be under medical supervision for 30 minutes.

The administration of immunoglobulin is recorded in established accounting forms indicating the batch number, release date, expiration date, manufacturer, date of administration, dose, and nature of the reaction to the administration.

Drug Interactions

It is not allowed to mix immunoglobulin with other medicinal products.

For at least 6 weeks and up to 3 months after administration, immunoglobulins may reduce the effectiveness of live attenuated vaccines against viral diseases such as measles, rubella, mumps, and chickenpox. Vaccination against these diseases should be carried out no earlier than 3 months after the administration of immunoglobulin. The interval between the administration of immunoglobulin and the measles vaccine may be extended to 1 year. In this regard, patients who need to be vaccinated against measles should first be examined for the presence of specific antibodies.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.