Immunoglobulins

CSL Behring manufactures a range of immunoglobulin products under a National Blood Authority supply agreement and these include intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg), normal human immunoglobulin and specific immunoglobulins (eg, RhD, cytomegalovirus, hepatitis B, tetanus and zoster immunoglobulin).

Prescription of immunoglobulin products often requires specific specialist consultation. Always refer to and read the product's information sheet prior to administering.

 

CMV immunoglobulin is used to prevent CMV infection in bone marrow, renal, cardiac and liver transplant recipients who are CMV antibody negative and the donor is CMV positive.

It may also be used to support treatment of an established CMV infection (eg, CMV pneumonia, renal parenchymal infection) in association with antiviral drugs (eg, ganciclovir, valganciclovir).

CMV Immunoglobulin-VF is available in single vials containing 1.5 million units of CMV antibody.

CMV Immunoglobulin-VF product information

This link takes you to CSL Behring's web information about CMV Immunoglobulin-VF. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of CMV Immunoglobulin-VF.

Hepatitis B immunoglobulin is used to prevent hepatitis B infection in people who are non-immune and have been exposed to hepatitis B virus and who have not received prior vaccination, or whose vaccination regimen is incomplete or their hepatitis B antibody level is inadequate (ie. <10 IU/L). 

Hepatitis B immunoglobulin is also used to help prevent hepatitis B infection in babies born to mothers with hepatitis B.

Hepatitis B Immunoglobulin-VF is available in 100 IU or 400 IU vials.

Hepatitis B Immunoglobulin-VF product information

This link takes you to CSL Behring's web information about Hepatitis B Immunoglobulin-VF. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Hepatitis B Immunoglobulin-VF.

Normal immunoglobulin may be supplied under the national blood arrangements for the following two purposes:

1. Public health disease control activities to treat susceptible contacts of an indicated infectious disease (hepatitis A, measles, poliomyelitis or rubella), where directed by the public health units in each state and territory. Download the order form from the National Blood Authority website here.

2. Treatment of immunodeficiency conditions for which the product is indicated, for patients for whom treatment with IVIg or SCIg (where available) are both contraindicated. Contact your local Medical Services to request for this indication.

Normal immunoglobulin will not be routinely provided for any other purpose, including travel prophylaxis for hepatitis A.

For more information refer to the National Blood Authority website.

Normal Immunoglobulin-VF is available in 2 mL and 5 mL vials.

Normal Immunoglobulin-VF product information.

This link takes you to CSL Behring's web information about Normal Immunoglobulin-VF. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Normal Immunoglobulin-VF.

Rh(D) immunoglobulin (or Anti-D) prophylaxis is routinely offered to RhD negative women during pregnancy and following birth of an RhD positive baby to help prevent Haemolytic Disease of the Newborn due to anti-D.

Use of RhD immunoglobulin is also indicated for other potentially sensitising events during pregnancy (eg. amniocentesis, miscarriage or stillbirth) or when an RhD negative woman of child-bearing potential receives a transfusion of RhD positive blood products.

Rh(D) immunoglobulin should ideally be given within 72 hours of a sensitising event. 

The NBA/NHMRC Guidelines on the prophylactic use of RhD Immunoglobulin (Anti-D) in obstetrics detail the appropriate use and indications of RhD immunoglobulin; additional information is also available from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG).

You can download or order a range of educational support materials about the use of RhD immunoglobulin.

RhD immunoglobulin is available in 250 IU and 625 IU vials.

For indications requiring intravenous (IV) RhD immunoglobulin the alternative CSL Behring product Rhophylac® is available. 

Rh(D) Immunoglobulin-VF (Anti-D) product information

This link takes you to CSL Behring's web information about Rh(D)-VF Immunoglobulin-VF. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Rh(D) Immunoglobulin-VF.

Rhophylac® is supplied when intravenous administration of RhD immunoglobulin is required. It is indicated for large fetomaternal haemorrhage (FMH) or for inadvertent or emergency transfusion of RhD positive blood to an RhD negative female of childbearing potential where intramuscular administration of RhD immunoglobulin may be impractical or the intramuscular route is contraindicated.

Rhophylac®, manufactured by CSL Behring using imported plasma, and is supplied as a prefilled syringe containing 1500 IU of anti-D. 

Rhophylac® frequently asked questions

Rhophylac® product information

This link takes you to CSL Behring's web information about Rhophylac®. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Rhophylac®.

Intramuscular administration

Intramuscularly administered tetanus immunoglobulin is used for passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful.

Intramuscularly administered tetanus immunoglobulin is also given to fully immunised individuals with a tetanus prone wound if more than 10 years have elapsed since their last dose of toxoid or vaccine. In these cases a full course of vaccination should also be commenced.

Individuals with a humoral immune deficiency should be given tetanus immunoglobulin if they have received a tetanus-prone injury, regardless of the time since their last dose of tetanus-containing vaccine.

Tetanus Immunoglobulin-VF (For Intramuscular Use) is available in 250 IU vials.

Tetanus Immunoglobulin-VF (For intramuscular Use) - product information

This link takes you to CSL' Behring's web information about Tetanus Immunoglobulin-VF (For Intramuscular Use). You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Tetanus Immunoglobulin-VF (For Intramuscular Use).

Intravenous administration

Intravenously administered tetanus immunoglobulin is used in the management of clinical tetanus. A course of vaccination should also be commenced once the clinical condition has stabilised.

Tetanus Immunoglobulin-VF (For Intravenous Use) is available in 4000 IU vials.

Tetanus Immunoglobulin-VF – (For Intravenous Use) - product information

This link takes you to CSL Behring's web information about Tetanus Immunoglobulin-VF (For Intravenous Use). You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Tetanus Immunoglobulin-VF (For Intravenous Use).

Zoster immunoglobulin is indicated for prophylaxis against varicella zoster virus high-risk individuals exposed to varicella (chicken pox) or herpes zoster:

  • pregnant women susceptible to varicella infection
  • neonates whose mothers develop varicella within 7 days before and 2 days after delivery or when exposed to varicella in the first month of life, if the mother has no history of varicella infection and no antibodies
  • premature infants (born at <28 weeks gestation or with low birth weight <1000g exposed to varicella while still in hospital regardless of maternal history
  • adults and children with no history of varicella and/or who are not immune, are receiving immunosuppresive therapy including steroids, cytostatic agents, radiotherapy, recent stem cell transplantation, or who have congenital or acquired immunodeficiency disorders and are not receiving replacement therapy with immunoglobulin.

Zoster immunoglobulin is not indicated for prophylaxis in immunodeficient children or adults exposed to varicella where there is recent evidence of detectable varicella antibodies.

Zoster immunoglobulin should be administered within 96 hours of exposure (although it may still be effective if given within 10 days).

Zoster Immunoglobulin-VF is available in 250 IU vials.

Zoster Immunoglobulin-VF product information

This link takes you to CSL Behring's web information about Zoster Immunoglobulin-VF. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Zoster Immunoglobulin-VF.

 

 

The Australian Immunisation Handbook recommends that immunoglobulin containing blood products, except for RhD immunoglobulin, should not be administered for 3 weeks following vaccination with live attenuated viral vaccines. MMR containing or varicella vaccines should not be given for 3-11 months following the receipt of any blood product, including plasma or platelets.

Further information regarding vaccination and use of immunoglobulins should be obtained from the latest edition of the handbook.