Rabies Immune Globulin (Human) USP, IMOGAM ^® RABIES - HT, is a sterile solution of antirabies immunoglobulin (10-18% protein) for intramuscular administration. It is prepared by cold alcohol fractionation from pooled venous plasma of individuals immunized with Rabies Vaccine prepared from human diploid cells (HDCV). The product is stabilized with 0.3 M glycine. The globulin solution has a pH of 6.8 ± 0.4 adjusted with sodium hydroxide or hydrochloric acid. No preservatives are added. IMOGAM ^® RABIES † HT is a colorless to light opalescent liquid.

A heat-treatment process step (58° to 60° C, 10 hours) to inactivate viruses has been added to further reduce any risk of blood-borne viral transmission. The inactivation and removal of model and laboratory strains of enveloped and nonenveloped viruses during the manufacturing and heat treatment processes for IMOGAM^® RABIES - HT has been validated by spiking experiments. Human immunodeficiency virus, type 1 (HIV-1) and type 2 (HIV-2) were selected as relevant viruses for plasma derived products. Bovine viral diarrhea virus and Sindbis virus were chosen to model hepatitis C virus. Porcine pseudorabies virus was selected to model hepatitis B virus and herpes virus. Avian reovirus was used to model nonenveloped RNA viruses and for its relative resistance to inactivation by chemical and physical methods. Finally, porcine parvovirus was selected to model human parvovirus B19 and its notable resistance to inactivation by heat treatment.

Removal and/or inactivation of the studied enveloped and non-enveloped model viruses was demonstrated at the precipitation III stage of manufacturing. In addition, inactivation was demonstrated to occur during the 10-hour (58° to 60° C) heat treatment process for the studied enveloped and non-enveloped viruses.

The product is standardized against the United States (US) Standard Rabies Immune Globulin. The US unit of potency is equivalent to the International Unit (IU) for rabies antibody. The average potency is 150 IU/mL.

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