Transfusion medicine handbook

5. Fractionated Products

5.4 Immunoglobulin Preparations

General Considerations      

Immunoglobulin products are fractionated blood products made from pooled human plasma. The manufacturing process contains steps to reduce the possibility of virus transmission, such as pasteurisation and nanofiltration.

Precautions

• Immunoglobulin products approved for intramuscular injection must not be administered intravenously because of the potential for severe adverse reactions. They should be given slowly by deep intramuscular injection using an appropriate sized needle and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel.
• If an intramuscular dose of more than 5 mL is required, it is advisable to administer in divided doses at different sites. Hyaluronidase and/or a suitable local anaesthetic may be added to the injection if desired. When large doses of immunoglobulins are required, consider using an alternative product suitable for intravenous administration.
• Intramuscular injection of immunoglobulin products should be avoided in patients with a low platelet count. In these circumstances they may be given subcutaneously.
• Immunoglobulin products approved for subcutaneous infusion must not be administered intravenously because of the potential for severe adverse reactions.
• Immunoglobulin products should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. In the case of allergic shock, treatment should follow recommended guidelines for managing anaphylaxis.

Contraindications

Immunoglobulin products are contraindicated in individuals:

• With isolated immunoglobulin A (IgA) deficiency unless they have been tested and shown not to have circulating anti-IgA antibodies.
• Who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.

Interactions with Other Drugs

• Immunoglobulin should not be mixed with other pharmaceutical products, except as indicated by the manufacturer.
• Passively acquired antibody can interfere with the response to live, attenuated virus vaccines. Therefore, administration of such vaccines, e.g., measles and varicella, should be deferred for at least 3 months after passive immunisation with immunoglobulin preparations and antibody-containing blood components, i.e., whole blood, resuspended red cells, plasma and platelets. General Recommendations on Immunization from the Advisory Committee on Immunization Practices (ACIP), including recommended deferral intervals, are available from the Centers for Disease Control and Prevention (CDC) at www.cdc.gov/vaccines/. Consultation with a NZBS Transfusion Medicine Specialist/ Medical Officer is recommended.
• By the same token, immunoglobulins and antibody-containing blood components should not be administered for at least two weeks after a live vaccine has been given.
• Inactivated vaccines may be administered concurrently with passive antibody (although in separate syringes) to induce active immunity, as is sometimes done for tetanus-prone wounds.

Passive Transfer of Antibodies and Interference with Serological Testing

After injection of immunoglobulin, the transient rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing. Although it has not been determined whether or not immunoglobulin products can transmit human parvovirus B19, they are known to contain antibodies to the virus.

Adverse Reactions

• Local tenderness, erythema and stiffness may occur at the site of injection and may persist for several hours. This may occur after any intramuscular injection.
• Mild pyrexia, malaise, drowsiness and urticaria have occasionally been reported after injections of immunoglobulins.
• True allergic responses are rare. Skin lesions, headache, dizziness, nausea, generalised hypersensitivity reactions and convulsions have been reported on rare occasions. These occur more frequently in patients who have a profound hypogammaglobulinaemia.