MOGAM RABIES-HT- human rabies virus immune globulin injection, solution
Sanofi Pasteur Inc.
AHFS Category: 80:04
RIG
Rx only
FOR WOUND INFILTRATION AND INTRAMUSCULAR USE ONLY
DESCRIPTION
Rabies Immune Globulin (Human) USP, Heat Treated, Imogam� Rabies � HT, is a sterile solution of antirabies immunoglobulin (10-18% protein) for wound infiltration and intramuscular administration. Rabies immune globulin (RIG) 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 immune 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 is used to further reduce any risk of blood-borne viral transmission. The inactivation and removal of model laboratory strains of enveloped and non-enveloped viruses during the manufacturing and heat treatment processes for Imogam� Rabies � HT have 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 non-enveloped 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 spiked 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 representative 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 minimal potency is 150 IU/mL.
The vial stopper is not made with natural rubber latex.
CLINICAL PHARMACOLOGY
Rabies is a viral infection transmitted in the saliva of infected mammals. Worldwide, both dog and bat saliva exposures appear to be major contributors (see below) with or without apparent bites. The virus enters the central nervous system of the host causing an encephalomyelitis that is fatal.
Unlike the situation in developing countries, wild animals are the most important potential source of infection for humans and domestic animals in the US. Most reported cases of rabies occur among carnivores, primarily raccoons, skunks, and foxes and various species of bats. For the past several decades, the majority of naturally acquired, indigenous human rabies cases in the US have resulted from variants of rabies viruses associated with insectivorous bats. (1) Hawaii historically has never had an indigenous case of rabies. (2)
The United States has experienced a substantial decrease in human rabies cases acquired from indigenous domestic animals. International travelers to areas where canine rabies remains enzootic are at risk for exposure to rabies from domestic and feral dogs. (1) Infectious sources of cases of rabies in dogs in the United States in recent years were wildlife reservoirs or dogs that were translocated from localities where canine rabies virus variants still circulate.
IMOGAM RABIES-HT Indications and Usage
Rabies Immune Globulin (Human) Heat Treated, Imogam� Rabies � HT, in conjunction with the standard series of Rabies Vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with Rabies Vaccine. Previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. Administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated). (1)
