Rabies immunoglobulin - use of unregistered product

Rabies immunoglobulin - use of unregistered product

14 January 2014

The following information has been provided by NSW Ministry of Health for distribution to GPs.

Summary
  • Rabies immunoglobulin (RIg) is one component of the post-exposure prophylaxis for people who may have been exposed to rabies virus or other lyssaviruses.
  • RIg is in short supply globally and Australia has exhausted its supply of the registered human RIg product (Imogam).
  • Patients will be offered an equivalent but unregistered product, KamRAB, manufactured in Israel.
  • KamRAB has the same dosage, strength and route of administration as the registered human RIg product.
  • KamRAB is being made available under the Therapeutic Goods Administration (TGA) Special Access Scheme via local public health units (PHUs) until supplies of the registered product are re-established.
  • As KamRAB is a blood product, the TGA requires patients or their parent/guardian to provide informed consent before KamRAB is administered.
  • GPs are required to return completed Special Access Scheme category A forms and blood products consent forms to the local PHU.
  • GPs are asked to report any adverse event directly to the local PHU on 1300 066 055.
Rabies Facts
  • The risk of dying of rabies following a bite from an assumed rabid animal where no treatment is provided is estimated to be 15-80% depending on what part of the body was bitten and the species of animal. Scratches are associated with a lower risk of dying of 2-5%.
  • Without the administration of RIg, there is a risk of developing the infection prior to the development of antibodies in response to vaccine. It takes about 14 to 21 days after vaccination for most people to develop their own antibodies.
  • Following potential exposure to rabies or other lyssaviruses, it is extremely important that appropriate treatment commences as soon as practicable.
  • Post-exposure prophylaxis (PEP) for rabies virus and other lyssavirus exposures consists of prompt wound management, vaccine and RIg administration. The appropriate combination of these components depends on the extent of the exposure, the animal source of the exposure, the persons immune status and their previous vaccination history. The Australian Immunisation Handbook (10th edn.) provides the recommended schedule for PEP.
KamRAB
  • As with other human immunoglobulin preparations, KamRAB is produced from the blood of human donors. The product is manufactured in Israel from screened donors in the United States from collection centres approved by the US Food and Drug Administration (FDA). Viral testing is performed on donations using FDA approved kits and 2 steps (pasteurisation and solvent/detergent incubation) have been used during manufacture to reduce the risk of viral contamination.
  • As KamRAB is not registered for use in Australia the product has not yet undergone a full assessment of safety and efficacy by the TGA in Australia. KamRAB is produced under Good Manufacturing Practices (GMP) as certified by the government of the country of origin.