Public Health and Clinical Services Division

Government of Western Australia

Department of Health

KamRAB HUMAN Rabies immunoglobulin

INFORMATION for patients and families

August 2015

Summary

If you have been potentially exposed to rabies or Australian bat lyssavirus (ABLV), treatment is required as soon as possible after the exposure to prevent you from getting rabies.
You will require a series of rabies vaccines, and your doctor will assess whether you require an injection of human rabies immunoglobulin (rabies immunoglobulin) in addition to vaccine.
Rabies immunoglobulin is in short supply globally and our supplies of the product that is registered for use in Australia have been exhausted. An alternative product, KamRAB, which is currently not registered for use in Australia, is being offered to people who need protection against rabies.
Patients or their parent/guardian are required to give sign a consent form before KamRAB can be administered.
See your doctor if you feel unwell or notice any adverse reaction following the administration of KamRAB.

Rabies virus and ABLV belong to a group of viruses called lyssaviruses. All lyssaviruses cause a similar illness known as rabies, which affects the central nervous system and is almost always fatal.
Rabies is transmitted through the saliva of an infected animal. People can become infected if bitten or scratched by an infected animal or by being exposed to infected animals’ saliva through broken skin, eyes, nose or mouth. Exposures to faeces, urine or blood from bats or other animalsare not a risk for rabies infection, and nor is living, playing or walking near bat roosting areas.
Bats in Australia or anywhere overseas can be infected with ABLV. Wild or domestic land dwelling mammals (especially dogs, cats and monkeys) overseas countries where rabies occurs can be infected withrabies.
If you have beenpotentially exposed to rabies or ABLV, it is extremely important that you receive appropriate treatment commences as soon as possible. Incorrect or incomplete treatment is will not prevent infection.

Everyone who has been potentially exposed to rabies or ABLV needs a course of rabies vaccine.
Some people will also require rabies immunoglobulin which provides short term protection while the body produces its own protective antibodies in response to rabies vaccine.
Your doctor will ask about your rabies vaccination history, medical history and the type of exposure to assess whether you require rabies immunoglobulin in addition to vaccine.

Rabies immunoglobulin contains antibodies to rabies. It is prepared from blood that has been donated by people who have previously been vaccinated for rabies.
Is in short supply globally and our supplies of the product that is registered for use in Australia have been exhausted.
As an interim measure,public health authorities have decided to make another HRIG product, KamRAB, available for people who need protection against rabies.
Further information about rabies immunoglobulin is available from the Australian Immunisation Handbook 10th Edition 2013 on the Immunise Australia website.

KamRAB and the registered product that is normally available in Australia are both produced from the blood of human donors. As KamRAB is not registered for use in Australia, the product has not yet undergone a full assessment of safety and effectiveness by the Therapeutic Goods Administration (TGA) in Australia.
KamRAB is produced in Israel under ‘Good Manufacturing Practices’ (GMP) as certified bythe Israeli government. Screening processes for blood borne infections are the same as those used in the United States (US). The product is currently undergoing clinical trials to allow registration in the US.

The risk of contracting rabies varies with the type of animal and the type of exposure (bite or scratch). If a person who was exposed becomes infected with rabies, the disease is almost always fatal.
Blood products carry a small risk of transmitting blood-borne infections such as hepatitis C, hepatitis B and HIV. The manufacturer has indicated that KamRAB is manufactured using the same standard measures as those used in the manufacture of the previous registered rabies immunoglobulin product to prevent infections resulting from the use of medicinal products prepared from human blood or plasma.
As with all medicines, there is a small chance that you will have an adverse reaction (or side effect) to KamRAB, such as swelling, pain at the site of injection, or an allergic reaction.

What happens if I refuse treatment WITH KAMRAB?

It takes about 14 to 21 days for most people to develop their own antibodiesafter receiving the rabies vaccine.If you refuse KamRAB, there is a risk that you could develop rabies prior to the development of your own antibodies. It is for this reason that the World Health Organization recommends rabies immunoglobulin in addition to vaccine for certain exposures and patients.

What do i do if i have an adverse reaction?

See your doctor if you are concerned about any possible adverse reaction. Local reactions such as swelling, as well as systemic reactions are possible.
Adverse reactions can be reported to the Western Australian Vaccine Safety Surveillance system (WAVSS