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Kamrab
Published
Product name
Kamrab
Active ingredient
Rabies immunoglobin
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Kamrab (rabies immunoglobulin) was approved for the following therapeutic use:
Kamrab is rabies immunoglobulin indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. Kamrab should be administered concurrently with a full course of rabies vaccine.
- Do not administer additional (repeat) doses of Kamrab once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine.
- Do not administer Kamrab to patients with a history of a complete pre-exposure or postexposure vaccination regimen and confirmed adequate rabies antibody titre.
How this medicine works
Rabies is a zoonotic disease caused by ribonucleic acid (RNA) viruses in the family Rhabdoviridae, genus Lyssavirus. Virus is typically present in the saliva of rabid mammals and is transmitted primarily through a bite. Kamrab is infiltrated into the inoculation site (that is at the beginning of anti-rabies postexposure prophylaxis(PEP)) to previously unvaccinated persons, to provide immediate passive rabies virus neutralising antibody protection until the patient’s immune system responds to vaccination by actively producing antibodies. A protective threshold for rabies virus neutralising antibodies (RVNA) has never been established. However, the World Health Organization has generally accepted a RVNA of at least 0.5 IU/mL measured 14 days after initiation of PEP as protective. By comparison, the Advisory Committee on Immunisation Practices at the Centers for Disease Control recommends complete neutralisation of rabies virus at a 1:5 serum dilution by a rapid fluorescent focus inhibition test (RFFIT) from one to two weeks after prophylaxis; this corresponds to RVNA about 0.1 to 0.2 IU/mL. In support of these recommendations, there has been almost no documented clinical disease when the current rabies PEP regimen is administered appropriately.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Kamrab was considered favourable for the therapeutic use approved.
Sponsor