KAMRAB

What it is

KamRAB is rabies immunoglobulin solution for injection, supplied in single-use vials containing 2 mL or 10 mL, with each mL of solution containing 150 IU rabies immunoglobulin from human plasma. It is a sterile solution for injection that is clear to slightly opalescent, colourless to pale yellow.

Approved indications

— Passive, transient post-exposure prophylaxis 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. KamRAB should not be administered to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titre.

Dosing overview

The recommended dose of KamRAB is 20 IU/kg body weight, given at the time of the first vaccine dose. When the bite site is known and infiltration is feasible, as much of the dose as possible should be infiltrated into and around any detectable bite wounds, with the remaining dose administered intramuscularly at a site distant from the rabies vaccine site. When the bite site is unknown or infiltration is difficult, the full dose should be administered intramuscularly at a site distant from the vaccine site. If a large intramuscular volume is required (more than 2 mL for children or more than 5 mL for adults), the total volume should be administered in divided doses at different sites.

Key safety warnings

KamRAB should not be injected into a blood vessel because of the risk of severe allergic or hypersensitivity reactions, including anaphylactic shock. KamRAB can induce a fall in blood pressure associated with an anaphylactic reaction, even in patients who tolerated previous treatment with human immunoglobulin. Epinephrine should be available for treatment of acute anaphylactic symptoms. KamRAB administration may interfere with the development of an immune response to live attenuated virus vaccines. Avoid immunization with measles vaccine within 4 months after KamRAB administration and avoid immunization with other live attenuated virus vaccines within 3 months after KamRAB administration. Standard measures to prevent infections from medicinal products prepared from human blood or plasma include donor selection, screening, and virus inactivation, but the possibility of transmitting infective agents cannot be totally excluded, including unknown or emerging viruses and other pathogens.

Contraindications

Because of the life-threatening risk due to rabies, there are no contraindications to the administration of rabies immunoglobulin.

PBS listing

No PBS listing information is available in the provided sources.

Regulatory history

The TGA approved KamRAB on 11 August 2021 for the passive, transient post-exposure prophylaxis of rabies infection. The product was first listed on the ARTG on 16 August 2021 under licence category RE. KamRAB is subject to additional monitoring in Australia, which will allow quick identification of new safety information.