About The Drug Rabies Immune Globulin aka Human) (Imogam Rabies
Find Rabies Immune Globulin side effects, uses, warnings, interactions and indications. Rabies Immune Globulin is also known as Human) (Imogam Rabies.
Rabies Immune Globulin
About Rabies Immune Globulin aka Human) (Imogam Rabies |
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What's The Definition Of The Medical Condition Rabies Immune Globulin?Clinical Pharmacology CLINICAL PHARMACOLOGY The usefulness of prophylactic rabies antibody in preventing rabies in humans when administered immediately after exposure was dramatically demonstrated in a group of persons bitten by a rabid wolf in Iran.1,2 Similarly, beneficial results were later reported from the U.S.S.R.3 Studies coordinated by WHO helped determine the optimal conditions under which antirabies serum of equine origin and rabies vaccine can be used in man.4-7 These studies showed that serum can interfere to a variable extent with the active immunity induced by the vaccine, but could be minimized by booster doses of vaccine after the end of the usual dosage series.
Preparation of rabies immune globulin of human origin with adequate potency was reported by Cabasso et al.8 In carefully controlled clinical studies, this globulin was used in conjunction with rabies vaccine of duck-embryo origin (DEV).8,9 These studies determined that a human globulin dose of 20 IU/kg of rabies antibody, given simultaneously with the first DEV dose, resulted in amply detectable levels of passive rabies antibody 24 hours after injection in all recipients.
The injections produced minimal, if any, interference with the subject's endogenous antibody response to DEV.
More recently, human diploid cell rabies vaccines (HDCV) prepared from tissue culture fluids containing rabies virus have received substantial clinical evaluation in Europe and the United States.10-16 In a study in adult volunteers, the administration of Rabies Immune Globulin (Human) did not interfere with antibody formation induced by HDCV when given in a dose of 20 IU per kilogram body weight simultaneously with the first dose of vaccine.15 In a clinical study in eight healthy human adults receiving a 20 IU/kg intramuscular dose of Rabies Immune Globulin (Human) treated with solvent/detergent, BayRab® (rabies immune globulin (human) solvent/detergent treated) , detectable passive rabies antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period.
These results are consistent with prior studies 17,18 with non-solvent/detergent treated product.
REFERENCES 1.
Baltazard M, Bahmanyar M, Ghodssi M, et al: Essai pratique du sérum antirabique chez les mordus par loups enragés.
Bull WHO 13:747-72, 1955.
2.
Habel K, Koprowski H: Laboratory data supporting the clinical trial of antirabies serum in persons bitten by a rabid wolf.
Bull WHO 13:773-9, 1955.
3.
Selimov M, Boltucij L, Semenova E, et al: [The use of antirabies gamma globulin in subjects severely bitten by rabid wolves or other animals.] J Hyg Epidemiol Microbiol Immunol (Praha) 3:168-80, 1959.
4.
Atanasiu P, Bahmanyar M, Baltazard M, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons.
Bull WHO 14:593-611, 1956.
5.
Atanasiu P, Bahmanyar M, Baltazard M, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons: Part II.
Bull WHO 17:911-32, 1957.
6.
Atanasiu P, Cannon DA, Dean DJ, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine innoculations in non-exposed persons: Part 3.
Bull WHO 25:103-14, 1961.
7.
Atanasiu P, Dean DJ, Habel K, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons: Part 4.
Bull WHO 36:361-5, 1967.
8.
Cabasso VJ, Loofbourow JC, Roby RE, et al: Rabies immune globulin of human origin: preparation and dosage determination in non-exposed vol-unteer subjects.
Bull WHO 45:303-15, 1971.
9.
Loofbourow JC, Cabasso VJ, Roby RE, et al: Rabies immune globulin (human): clinical trials and dose determination.
JAMA 217(13): 1825-31, 1971.
10.
Plotkin SA: New rabies vaccine halts disease — without severe reactions.
Mod Med 45(20):45-8, 1977.
11.
Plotkin SA, Wiktor TJ, Koprowski H, et al: Immunization schedules for the new human diploid cell vaccine against rabies.
Am J Epidemiol 103(1):75-80, 1976.
12.
Hafkin B, Hattwick MA, Smith JS, et al: A comparison of a WI-38 vaccine and duck embryo vaccine for preexposure rabies prophylaxis.
Am J Epidemiol 107(5):439-43, 1978.
13.
Kuwert EK, Marcus I, Höher PG: Neutralizing and complement-fixing antibody responses in pre- and postexposure vaccinees to a rabies vaccine produced in human diploid cells.
J Biol Stand 4(4):249-62, 1976.
14.
Grandien M: Evaluation of tests for rabies antibody and analysis of serum responses after administration of three different types of rabies vac-cines.
J Clin Microbiol 5(3):263-7, 1977.
15.
Kuwert EK, Marcus I, Werner J, et al: Postexpositionelle Schutzimpfung des Menschen gegen Tollwut mit einer neu-entwickelten Gewebekulturvakzine (HDCS-Impfstoff).
Zentralbl Bakteriol [A] 239(4):437-58, 1977.
16.
Bahmanyar M, Fayaz A, Nour-Salehi S, et al: Successful protection of humans exposed to rabies infection: postexposure treatment with the new human diploid cell rabies vaccine and antirabies serum.
JAMA 236(24):2751-4, 1976.
17.
American Hospital Formulary Service.
Drug Information.
Section 80:04.
Rabies immune globulin.
Bethesda, American Society for Health-Systems Pharmacy, 1997, p.
2545-7.
18.
Rubin Rh, Sikes RK, Gregg MB: Human rabies immune globulin.
Clinical trials and effects on serum antiglobulins.
JAMA 224:871-4, 1973.
Clinical Pharmacology CLINICAL PHARMACOLOGY Rabies is a viral infection transmitted in the saliva of infected mammals.
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.
After the marked decrease of rabies cases among domestic animals in the US in the 1940s and 1950s, indigenously acquired rabies among humans decreased substantially.
1, 2 In 1950, for example, 4, 979 cases of rabies were reported among dogs, and 18 cases were reported among humans.
Between 1980 and 1997, 95 to 247 cases were reported each year among dogs, and on average only two human cases were reported each year in which rabies was attributable to variants of the virus associated with indigenous dogs.
1, 3 Thus, the likelihood of human exposure to a rabid domestic animal in the US has decreased greatly.
However, during the same period, 12 cases of human rabies were attributed to variants of the rabies virus associated with dogs from outside the US.
1, 4, 5 Therefore, international travelers to areas where canine rabies is still endemic have an increased risk of exposure to rabies.
1 Rabies among wildlife – especially raccoons, skunks, and bats – has become more prevalent since the 1950s, accounting for > 85% of all reported cases of animal rabies every year since 1976.
1, 2 Rabies among wildlife occurs throughout the continental US; only Hawaii remains consistently rabies-free.
Wildlife is the most important potential source of infection for both humans and domestic animals in the US.
Since 1980, a total of 21 (58%) of the 36 human cases of rabies diagnosed in the US have been associated with bat variants.
1, 3, 6, 7 In most other countries – including most of Asia, Africa, and Latin America – dogs remain the major species with rabies and the most common source of rabies among humans.
Twelve (33%) of the 36 human rabies deaths reported to Centers of Disease Control and Prevention (CDC) from 1980 through 1997 appear to have been related to rabid animals outside the US.
1, 3, 7 Although rabies among humans is rare in the US, every year approximately 16, 000 to 39, 000 persons receive postexposure prophylaxis.
1, 8 In order to manage potential human exposures to rabies appropriately, the risk of infection must be accurately assessed.
Administration of rabies postexposure prophylaxis is a medical urgency, not a medical emergency, but decisions must not be delayed.
Systemic prophylactic treatments occasionally are complicated by adverse reactions, but these reactions are rarely severe.
1, 9-13 Data on the safety, immunogenicity, and efficacy of active and passive rabies immunization have come from both human and animal studies.
Although controlled human trials have not been performed, extensive field experience from many areas of the world indicates that postexposure prophylaxis combining local wound treatment, passive immunization, and vaccination is uniformly effective when appropriately applied.
1, 14-19 Although no postexposure vaccine failures have occurred in the US since cell culture vaccines have been routinely used, failures have occurred abroad when some deviation was made from the recommended postexposure treatment protocol or when less than the currently recommended amount of antirabies sera was administered.
1, 20-23 Specifically, patients who contracted rabies after postexposure prophylaxis did not have their wounds cleansed with soap and water, did not receive their rabies vaccine injections in the deltoid area (i.
e.
, vaccine was administered in the gluteal area), or did not receive Rabies Immune Globulin (RIG) around the wound site.
1 Rabies antibody provides passive protection when given immediately to individuals exposed to rabies virus.
24 In a clinical study, Rabies Immune Globulin (Human) [RIG(H)] of adequate potency25 was used in conjunction with Rabies Vaccine of duck embryo origin.
25, 26 When a Rabies Immune Globulin (Human) dose of 20 IU/kg of rabies antibody was given simultaneously with the first dose of vaccine, levels of passive rabies antibody were detected 24 hours after injection in all individuals.
There was minimal or no interference with the immune response to the initial and subsequent doses of vaccine, including booster doses.
Studies of Rabies Immune Globulin (Human), 27 Imogam® Rabies, given with the first of five doses of Aventis Pasteur SA HDCV1 confirmed that passive immunization with 20 IU/kg of Rabies Immune Globulin (Human) provides maximum circulating antibody with minimum interference of active immunization by HDCV.
A double-blind randomized trial28 was conducted to compare the safety and antibody levels achieved following intramuscular injection of Imogam® Rabies – HT (heat treated) and Rabies Immune Globulin (Human), Imogam® Rabies (non-heat treated).
Each Rabies Immune Globulin (Human) was administered on day 0, either alone or in combination with the human diploid cell Rabies Vaccine (Imovax® Rabies) using the standard postexposure prophylactic schedule of day 0, 3, 7, 14, and 28.
Sixty-four healthy veterinary student volunteers were randomized into four parallel groups of 16 each to receive the following Rabies Immune Globulin (Human) and vaccine regimens: Imogam® Rabies HT + Imovax® Imogam® Rabies + Imovax® Imogam® Rabies HT + placebo Imogam® Rabies + placebo The treatment of both Rabies Immune Globulin (Human) and vaccine corresponded to the postexposure recommended dose of 20 IU/kg of Rabies Immune Globulin (Human) and was administered in three, equally divided IM injections of under 5 mL in either gluteus.
Serum rabies antibody levels were assessed before treatment and on days 3, 7, 14, 28, 35, and 42 by the Rabies Fluorescent Focus Inhibition Test (RFFIT).
Serum antibody levels were similar in the Imogam® Rabies – HT (rabies immune globulin (human)) and Imogam® Rabies groups.
By day three, 60% of each group had detectable antibody titers of ≥ 0.
05 IU/mL.
By day 14, the geometric mean titers (with 95% confidence interval) were 19 IU/mL (11-38) in the Imogam® Rabies – HT (rabies immune globulin (human)) + vaccine group and 31 IU/mL (20 to 48) in the Imogam® Rabies + vaccine group.
These differences were not statistically different.
Two subjects reported severe headaches, one in the Imogam® Rabies – HT (rabies immune globulin (human)) + placebo group and one in the Imogam® Rabies + Imovax® Rabies group.
One third of the volunteers had moderate systemic (headache and malaise) reactions.
These were equally distributed among the 4 treatment groups with no significant differences between the groups.
Both Imogam® Rabies – HT (rabies immune globulin (human)) and Imogam® Rabies were safe and without serious adverse events or allergic reactions.
The safety profile did not differ between groups, although Imogam® Rabies – HT (rabies immune globulin (human)) produced fewer and milder local reactions such as pain or tenderness at the injection site.
REFERENCES 1.
Recommendation of the Advisory Committee on Immunization Practices (ACIP).
Human Rabies prevention – United States, 1999.
MMWR 48:No.
RR-1, 1999 2.
Krebs JW, et al.
Rabies surveillance in the United States during 1996.
J Am Vet Med Assoc 211:1525-1539, 1997 3.
Noah DL, et al.
Epidemiology of human rabies in the United States, 1980 to 1996.
Ann Intern Med 128:922-930, 1998 4.
Centers for Disease Control and Prevention (CDC).
Human Rabies – New Hampshire, 1996.
MMWR 46:267-270, 1997 5.
Mitmoonpitak C, et al.
Current status of animal rabies in Thailand.
J Vet Med Sci 59:457-460, 1997 6.
CDC.
Human rabies – Montana and Washington, 1997.
MMWR 46:770-774, 1997 7.
CDC.
Human rabies – Texas and New Jersey, 1997.
MMWR 47:1-5, 1998 8.
Krebs JW, et al.
Causes, costs and estimates of rabies postexposure prophylaxis treatments in the United States.
J Public Health Manage Pract 4:57-63, 1998 9.
Bernard KW, et al.
Neuroparalytic illness and human diploid cell rabies vaccine.
JAMA 248:3136-3138, 1982 10.
CDC.
Systemic allergic reactions following immunization with human diploid cell rabies vaccine.
MMWR 33: 185-187, 1984 11.
Dreesen EW, et al.
Immune complex-like disease in 23 persons following a booster dose of rabies human diploid cell vaccine.
Vaccine 4:45-49, 1986 12.
Aoki FY, et al.
Immunogenicity and acceptability of a human diploid-cell culture rabies vaccine in volunteers.
Lancet 1: 660-662, 1975 13.
Cox JH, et al.
Prophylactic immunization of humans against rabies by intradermal inoculation of human diploid cell culture vaccine.
J Clin Microbiol 3:96-101, 1976 14.
Anderson LJ, et al.
Postexposure trial of a human diploid cell strain rabies vaccine.
J Infect Dis 142:133-138, 1980 15.
Bahmanyar M, et al.
Successful protection of humans exposed to rabies infection.
Postexposure treatment with the new human diploid cell rabies vaccine and antirabies serum.
JAMA 236:2751-2754, 1976 16.
Hattwick MAW.
Human rabies.
Public Health Rev 3:229-274, 1974 17.
Wiktor TJ, et al.
Development and clinical trials of the new human rabies vaccine of tissue culture (human diploid cell) origin.
Dev Biol Stand 40:3-9, 1978 18.
World Health Organization (WHO).
WHO expert committee on rabies.
Seventh Report.
Geneva.
WHO Tech Rep Ser 709:1-104, 1984 19.
Kuwert EK, et al.
Immunization against rabies with rabies immune globulin, human (RIGH) and a human diploid cell strain (HDCS) rabies vaccine.
J Biol Stand 6:211-219, 1978 20.
Wilde H, et al.
Failure of postexposure treatment of rabies in children.
Clin Infect Dis 22:228-232, 1996 21.
CDC.
Human rabies despite treatment with rabies immune globulin and human diploid cell rabies vaccine – Thailand.
MMWR 36: 759-760, 765, 1987 22.
Shill M, et al.
Fatal rabies encephalitis despite appropriate postexposure prophylaxis.
A case report.
N Engl J Med 316: 1257-1258, 1987 23.
Wilde H, et al.
Failure of rabies postexposure treatment in Thailand.
Vaccine 7:49-52, 1989 24.
Habel K, et al.
Laboratory data supporting clinical trial of antirabies serum in persons bitten by rabid wolf.
Bull WHO 13: 773-779, 1955 25.
Cabasso VJ, et al.
Rabies immune globulin of human origin: preparation and dosage determination in non-exposed volunteer subjects.
Bull WHO 45:303-315, 1971 26.
Loofbourow JC, et al.
Rabies immune globulin (human).
Clinical trials and dose determination.
JAMA 217:1825-1831, 1971 27.
Helmick CG, et al.
A clinical study of Mérieux human rabies immune globulin.
J Biol Stand 10:357-367, 1982 28.
Lang J, et al.
Evaluation of the safety and immunogenicity of a new, heat-treated human rabies immune globulin using a sham, postexposure prophylaxis of rabies.
Biologicals 26:7-15, 1998
Drug Description BayRab® Rabies Immune Globulin (Human) Solvent/Detergent Treated DESCRIPTION Rabies Immune Globulin (Human) — BayRab® (rabies immune globulin human solvent/detergent treated) treated with solvent/detergent is a sterile solution of antirabies immune globulin for intramuscular administration; it contains no preservative.
BayRab (rabies immune globulin human solvent/detergent treated) is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine.
The immune globulin is isolated from solubilized Cohn Fraction II.
The Fraction II solu-tion is adjusted to a final concentration of 0.3% tri-n-butyl phosphate ( TNBP) and 0.2% sodium cholate.
After the addition of solvent ( TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours.
After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration.
BayRab (rabies immune globulin human solvent/detergent treated) is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine.
BayRab (rabies immune globulin human solvent/detergent treated) is then incubated in the final container for 21–28 days at 20–27°C.
The product is standardized against the U.S.
Standard Rabies Immune Globulin to contain an average potency value of 150 IU/mL.
The U.S.
unit of potency is equivalent to the international unit (IU) for rabies antibody.
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for BayRab has been validated in laboratory studies.
Human Immunodeficiency Virus, Type 1(HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus ( BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Hepatitis B virus and the Herpes viruses; and Reo virus type 3 ( Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation.
Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III.
Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.
Drug Description Imogam® Rabies – HT Rabies Immune Globulin (human), USP DESCRIPTION Rabies Immune Globulin (Human) USP, Imogam® Rabies – HT (rabies immune globulin human) , 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 (rabies immune globulin human) 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 non-enveloped viruses during the manufacturing and heat treatment processes for Imogam® Rabies – HT (rabies immune globulin human) 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 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 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 minimal potency is 150 IU/mL.
Indications & Dosage INDICATIONS Rabies vaccine and BayRab (rabies immune globulin (human) solvent/detergent treated) should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.
BayRab (rabies immune globulin (human) solvent/detergent treated) should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given.
Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S.
Public Health Service Advisory Committee on Immunization Practices (ACIP).19 Every exposure to possible rabies infection must be individually evaluated.
The following factors should be considered before specific antirabies treatment is initiated: Species of Biting Animal Carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies in the United States since 1960.20 Unless the animal is tested and shown not to be rabid, postexposure prophylaxis should be initiated upon bite or nonbite exposure to these animals (see item 3 below).
If treatment has been initiated and subsequent testing in a competent laboratory shows the exposing animal is not rabid, treatment can be discontinued.
In the United States, the likelihood that a domestic dog or cat is infected with rabies varies from region to region; hence, the need for postexposure prophylaxis also varies.
However, in most of Asia and all of Africa and Latin America, the dog remains the major source of human exposure; exposures to dogs in such countries represent a special threat.
Travelers to those coun-tries should be aware that .50% of the rabies cases among humans in the United States result from exposure to dogs outside the United States.
Rodents (such as squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, and mice) and lagomorphs (including rabbits and hares) are rarely found to be infected with rabies and have not been known to cause human rabies in the United States.
However, from 1971 through 1988, woodchucks accounted for 70% of the 179 cases of rabies among rodents reported to CDC.21 In these cases, the state or local health department should be consulted before a decision is made to initiate post-exposure antirabies prophylaxis.
Circumstances of Biting Incident An unprovoked attack is more likely to mean that the animal is rabid.
(Bites during attempts to feed or handle an apparently healthy animal may generally be regarded as provoked.) Type of Exposure Rabies is transmitted only when the virus is introduced into open cuts or wounds in skin or mucous membranes.
If there has been no exposure (as described in this section), postexposure treatment is not necessary.
Thus, the likelihood that rabies infection will result from exposure to a rabid animal varies with the nature and extent of the exposure.
Two categories of exposure should be considered: Bite: any penetration of the skin by teeth.
Bites to the face and hands carry the highest risk, but the site of the bite should not influence the decision to begin treatment.22 Bat-associated strains of rabies can be transmitted to humans either directly through a bat's bite or indirectly through the bite of an animal previously infected by a bat.
Because some bat bites may be less severe, and can go completely undetected, unlike bites inflicted by larger animals, especially mammalian carnivores, rabies postexposure treatment should be considered for any physical contact with bats when bite or mucous membrane contact cannot be excluded.23 Nonbite: scratches, abrasions, open wounds or mucous membranes contaminated with saliva or any potentially infectious material, such as brain tissue, from a rabid animal constitute nonbite exposures.
If the material containing the virus is dry, the virus can be considered noninfectious.
Casual contact, such as petting a rabid animal and contact with the blood, urine, or feces (e.g., guano) of a rabid animal, does not constitute an exposure and is not an indication for prophylaxis.
Instances of air-borne rabies have been reported rarely.
Adherence to respiratory precautions will minimize the risk of airborne exposure.24 The only documented cases of rabies from human-to-human transmission have occurred in patients who received corneas transplanted from persons who died of rabies undiagnosed at the time of death.
Stringent guidelines for acceptance of donor corneas have reduced this risk.
Bite and nonbite exposures from humans with rabies theoretically could transmit rabies, although no cases of rabies acquired this way have been documented.
Vaccination Status of Biting Animal A properly immunized animal has only a minimal chance of developing rabies and transmitting the virus.
Presence of Rabies in Region If adequate laboratory and field records indicate that there is no rabies infection in a domestic species within a given region, local health officials are justified in considering this in making recommendations on antirabies treatment following a bite by that particular species.
Such officials should be consulted for current interpretations.
Rabies Postexposure Prophylaxis The following recommendations are only a guide.
In applying them, take into account the animal species involved, the circumstances of the bite or other exposure, the vaccination status of the animal, and presence of rabies in the region.
Local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis.
Local Treatment of Wounds: Immediate and thorough washing of all bite wounds and scratches with soap and water is perhaps the most effective measure for preventing rabies.
In experimental animals, simple local wound cleansing has been shown to reduce markedly the likelihood of rabies.
Tetanus prophylaxis and measures to control bacterial infection should be given as indicated.
Active Immunization: Active immunization should be initiated as soon as possible after exposure (within 24 hours).
Many dosage schedules have been evaluated for the currently available rabies vaccines and their respective manufacturers' literature should be consulted.
Passive Immunization: A combination of active and passive immunization (vaccine and immune globulin) is considered the acceptable postexposure prophylaxis except for those persons who have been previously immunized with rabies vaccine and who have documented adequate rabies antibody titer.
These individuals should receive vaccine only.
For passive immunization, Rabies Immune Globulin (Human) is preferred over antirabies serum, equine.16,19 It is recommended both for treatment of all bites by animals suspected of having rabies and for nonbite exposure inflicted by animals suspected of being rabid.
Rabies Immune Globulin (Human) should be used in conjunction with rabies vaccine and can be administered through the seventh day after the first dose of vaccine is given.
Beyond the seventh day, Rabies Immune Globulin (Human) is not indicated since an antibody response to cell culture vaccine is presumed to have occurred.
Rabies Postexposure Prophylaxis Guide19 Animal species Condition of animal at time of exposure/attack Treatment of exposed person [1] Dog and cat Healthy and available for 10 days of observation Rabid or suspected rabid Unknown (escaped) None, unless animal develops rabies [2] RIGH [3] and HDCV Consult public health officials Skunk, bat, fox, coyote, raccoon, bobcat, and other carnivores; woodchuck Regard as rabid unless animal proven negative by laboratory tests [4] RIGH [3] and HDCV Livestock, rodents, and lagomorphs (rabbits and hares) Consider individually.
Local and state public health officials should be consulted on questions about the need for rabies prophylaxis.
In most geo graphical areas bites of squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, mice, other rodents, rabbits, and hares almost never require antirabies postexposure prophylaxis [1] ALL POSTEXPOSURE PROPHYLAXIS SHOULD BEGIN WITH IMMEDIATE THOROUGH CLEANSING OF THE WOUND (IF ONE CAN BE DETECTED) WITH SOAP AND WATER.
If antirabies treatment is indicated, both Rabies Immune Globulin (Human) [RIGH] and human diploid cell rabies vaccine (HDCV) should be given as soon as possible, REGARDLESS of the interval from exposure.
[2] During the usual holding period of 10 days, begin postexposure prophylaxis at first sign of rabies in a dog or cat that has bitten someone.
If the animal exhibits clinical signs of rabies, it should be euthanized immediately and tested.
[3] If RIGH is not available, use antirabies serum, equine (ARS).
Do not use more than the recommended dosage.
[4] The animal should be euthanized and tested as soon as possible.
Holding for observation is not recommended.
Discontinue vaccine if immunofluorescence test results of the animal are negative.
DOSAGE AND ADMINISTRATION The recommended dose for BayRab (rabies immune globulin (human) solvent/detergent treated) is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first vaccine dose.8,9 It may also be given through the seventh day after the first dose of vaccine is given.
If anatomically feasible, up to the full dose of BayRab (rabies immune globulin (human) solvent/detergent treated) should be thoroughly infiltrated in the area around the wound and the rest should be administered intramuscularly in the gluteal area or lateral thigh muscle.
Because of risk of injury to the sciatic nerve, the central region of the gluteal area MUST be avoided; only the upper, outer quadrant should be used.26 BayRab (rabies immune globulin (human) solvent/detergent treated) should never be administered in the same syringe or needle or in the same anatomical site as vaccine.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Rabies postexposure prophylaxis schedule—United States, 199919 Vaccination status Treatment Regimen* Not previously vaccinated Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water.
If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds.
RIG Administer 20 IU/kg body weight.
If anatomically feasible, the full dose should be infiltrated around the wound(s) and any remaining volume should be administered IM at an anatomical site distant from vaccine administration.
Also, RIG should not be administered in the same syringe as vaccine.
Because RIG might partially suppress active production of antibody, no more than the recommended dose should be given.
Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area†), one each on days 0 § , 3, 7, 14, and 28.
Previously vaccinated¶ Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water.
If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds.
RIG RIG should not be administered.
Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area†), one each on days 0 § and 3.
HDCV=human diploid cell vaccine; PCEC=purified chick embryo cell vaccine; RIG=rabies immune globulin; RVA=rabies vaccine adsorbed; IM, intramuscular * These regimens are applicable for all age groups, including children.
† The deltoid area is the only acceptable site of vaccination for adults and older children.
For younger children, the outer aspect of the thigh may be used.
Vaccine should never be administered in the gluteal area.
§ Day 0 is the day the first dose of vaccine is administered.
¶ Any person with a history of preexposure vaccination with HDCV, RVA, or PCEC; prior postexposure prophylaxis with HDCV, RVA, or PCEC; or previous vaccination with any other type of rabies vaccine and a documented history of antibody response to the prior vaccination.
HOW SUPPLIED BayRab (rabies immune globulin (human) solvent/detergent treated) is packaged in 2 mL and 10 mL single dose vials with an average potency value of 150 international units per mL (IU/mL).
The 2 mL vial contains a total of 300 IU which is sufficient for a child weighing 15 kg.
The 10 mL vial contains a total of 1500 IU which is sufficient for an adult weighing 75 kg.
NDC Number Size 0026-0618-02 2 mL vial 0026-0618-10 10 mL vial Storage BayRab (rabies immune globulin (human) solvent/detergent treated) should be stored under refrigeration (2-8°C, 36-46°F).
Solution that has been frozen should not be used.
Caution U.S.
federal law prohibits dispensing without prescription.
Limited Warranty A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use.
These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients.
Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
No warranty, express or implied, including any warranty of merchantability or fitness is made.
Representatives of the Company are not authorized to vary the terms or the contents of the printed labeling, including the package insert for this product, except by printed notice from the Company's headquarters.
The prescriber and user of this product must accept the terms hereof.
REFERENCES 8.
Cabasso VJ, Loofbourow JC, Roby RE, et al: Rabies immune globulin of human origin: preparation and dosage determination in non-exposed vol-unteer subjects.
Bull WHO 45:303-15, 1971.
9.
Loofbourow JC, Cabasso VJ, Roby RE, et al: Rabies immune globulin (human): clinical trials and dose determination.
JAMA 217(13): 1825-31, 1971.
16.
Bahmanyar M, Fayaz A, Nour-Salehi S, et al: Successful protection of humans exposed to rabies infection: postexposure treatment with the new human diploid cell rabies vaccine and antirabies serum.
JAMA 236(24):2751-4, 1976.
19.
Recommendations of the Advisory Committee on Immunization Practices (ACIP): Rabies prevention—United States, 1999.
MMWR 48 (RR-1):1-21, 1999.
20.
Reid-Sanden FL, Dobbins JG, Smith JS, et al: Rabies surveillance in the United States during 1989.
J Am Vet Med Assoc 197(12):1571-83, 1990.
21.
Fishbein DB, Belotto AJ, Pacer RE, et al: Rabies in rodents and lagomorphs in the United States, 1971-1984: increased cases in the woodchuck (Marmota monax) in mid-Atlantic states.
J Wildl Dis 22(2):151-5, 1986.
22.
Hattwick MAW: Human rabies.
Public Health Rev 3(3):229-74, 1974.
23.
Epidemiologic Notes and Reports: Human Rabies—California, 1994.
MMWR 43(25):455-457, 1994.
24.
Garner JS, Simmons BP: Guideline for isolation precautions in hospitals.
Infect Control 4(4 Suppl):245-325, 1983.
26.
Recommendations of the Immunization Practices Advisory Committee (ACIP): General recommendations on immunization.
MMWR 38(13):205-14; 219-27, 1989.
Bayer Corporation, Pharmaceutical Division, Elkhart, IN 46515 USA.
Revision: April 1999.
Indications & Dosage INDICATIONS Rabies Immune Globulin (Human), Imogam® Rabies - HT (rabies immune globulin (human)) , is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with HDCV Rabies Vaccine in a pre-exposure or postexposure treatment series should receive only vaccine.
Persons who have received Rabies Vaccines other than HDCV, RVA (Rabies Vaccine Adsorbed) or PCEC (Purified Chick Embryo Cell Vaccine) vaccines should have confirmed adequate rabies antibody titers if they are to receive only vaccine.
1 Imogam® Rabies - HT (rabies immune globulin (human)) should be injected as promptly as possible after exposure along with the first dose of vaccine.
If initiation of treatment is delayed for any reason, Imogam® Rabies - HT (rabies immune globulin (human)) and the first dose of vaccine should still be given, regardless of the interval between exposure and treatment.
Imogam® Rabies - HT may be given up to eight days after the first dose of vaccine was given.
Rabies virus is usually transmitted by the bite of a rabid animal (dog, bat, etc.
) but can occasionally penetrate abraded skin contaminated with the saliva of infected animals.
Progress of the virus after exposure is believed to follow a neural pathway and the time between exposure and clinical rabies is a function of the proximity of the bite (or abrasion) to the central nervous system and the dose of virus injected.
The incubation is usually 2 to 6 weeks but can be longer.
After severe bites about the face and neck and arms, it may be as short as 10 days.
After initiation of the vaccine series (human diploid cell origin), it takes approximately one week for development of immunity to rabies; therefore, the value of immediate passive immunization with rabies antibodies in the form of Rabies Immune Globulin (Human) cannot be overemphasized.
Recommendations for passive and/or active immunization after exposure to an animal suspected of having rabies have been outlined by the WHO29 and by the United States Public Health Service Advisory Committee on Immunization Practices (ACIP).
1 Rationale of Treatment In the United States and Canada the following factors should be considered before specific antirabies treatment is indicated: Species of Biting Animal Carnivorous animals (especially skunks, foxes, coyotes, raccoons, dogs, bobcats, and cats) and bats are more likely to be infected with rabies than other animals.
Rats, mice, squirrels, hamsters, guinea pigs, gerbils, chipmunks and other rodents or rabbits and hares are rarely infected with rabies and have not been known to cause human rabies in the United States.
Their bites almost never call for antirabies prophylaxis; therefore, before initiating antirabies prophylaxis, the local or state health department should be consulted.
Because some bat bites may be less severe, and therefore more difficult to recognize, than bites inflicted by larger mammalian carnivores, rabies postexposure treatment should be considered for any physical contact with bats when bite or mucous membrane contact cannot be excluded.
1, 30, 31 Circumstances of Biting Incident An UNPROVOKED attack is more likely than a provoked attack to indicate that the animal is rabid.
Bites inflicted on a person attempting to feed or handle an apparently healthy animal should generally be regarded as PROVOKED.
Type of Exposure Rabies is commonly transmitted by inoculation with infectious saliva.
The likelihood that rabies infection will result from exposure to a rabid animal varies with the nature and extent of the exposure.
Two categories of exposure should be considered: Bite: Any penetration of the skin by teeth.
Nonbite: Scratches, abrasions, open wounds or mucous membranes contaminated with saliva or other potentially infectious material such as brain tissue from a rabid animal.
In addition, two cases of rabies have been attributed to airborne exposures in laboratories and two cases of rabies have been attributed to probable exposures to a bat-infested cave (Frio Cave, Texas).
1, 32-34 Casual contact with a rabid animal, such as petting the animal (without a bite or nonbite exposure as described above) does not constitute an exposure and is not an indication for prophylaxis.
The only documented cases of rabies due to human-to-human transmission occurred in patients who received corneas transplanted from persons who died of rabies undiagnosed at the time of death.
1, 35 Each exposure to possible rabies infection must be individually evaluated.
Local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis.
Vaccination Status of Biting Animal A properly immunized animal has only a minimal chance of developing rabies and transmitting the virus.
Postexposure Treatment of Rabies Local Treatment of Wounds Immediate and thorough local treatment of all bite wounds and scratches is perhaps the most effective preventive measure.
The wound should be thoroughly cleansed immediately with soap and water.
Tetanus prophylaxis and measures to control bacterial infection should be given as indicated.
Specific Treatment Postexposure antirabies treatment should always include both passive (preferably Rabies Immune Globulin - Human) and active (preferably Rabies Vaccine prepared from human diploid cells) immunization with one exception: persons who have been previously immunized with HDCV Rabies Vaccine in a pre-exposure or postexposure treatment series should receive only vaccine.
Persons who have received Rabies Vaccines other than HDCV, RVA or PCEC vaccines should have confirmed adequate rabies antibody titers if they are to receive only vaccine.
1 The combination of globulin and vaccine is recommended for both bite exposures and nonbite exposures (as described under "Rationale of Treatment") and regardless of the interval between exposure and treatment.
The sooner treatment is begun after exposure, the better.
Postexposure Treatment Guide The following recommendations are only a guide.
They should be applied in conjunction with knowledge of the animal species involved, circumstances of the bite or other exposure, vaccination status of the animal, and presence of rabies in the region.
Local and state public health officials should be consulted if questions arise about the need for rabies prophylaxis.
TABLE 11: RABIES POSTEXPOSURE PROPHYLAXIS GUIDE, UNITED STATES, 1999 Animal Type Evaluation and Disposition of Animal Postexposure Prophylaxis Recommendations Dogs, cats, and ferrets Healthy and available for 10 days observation Persons should not begin prophylaxis unless animal develops clinical signs of rabies.
* Rabid or suspected rabid Immediately vaccinate.
Unknown (e.
g.
escaped) Consult public health officials.
Skunks, raccoons, foxes, and most other carnivores; bats Regarded as rabid unless animal proven negative by laboratory tests† Consider immediate vaccination Livestock, small rodents, lagomorphs (rabbits and hares), large rodents (woodchucks and beavers), and other mammals Consider individually Consult public health officials.
Bites of squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, mice, other small rodents, rabbits, and hares almost never require antirabies postexposure prophylaxis *During the 10-day observation period, begin postexposure prophylaxis at the first sign of rabies in a dog, cat, or ferret that has bitten someone.
If the animal exhibits clinical signs of rabies, it should be euthanized immediately and tested.
†The animal should be euthanized and tested as soon as possible.
Holding for observation is not recommended.
Discontinue vaccine if immunofluorescence test results of the animal are negative.
DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit.
If either of these conditions exist, the vaccine should not be administered.
Imogam® Rabies - HT (rabies immune globulin (human)) should be used in conjunction with Rabies Vaccine such as Rabies Vaccine Imovax® Rabies, for intramuscular immunization, vaccine prepared from human diploid cell cultures.
The recommended dose of Imogam® Rabies - HT is 20 IU/kg (0.
133 mL/kg) or 9 IU/lb (0.
06 mL/lb) of body weight administered at time of the first vaccine dose.
25, 26, 43 The gluteal area should never be used for HDCV, RVA, or PCEC injections because administration of HDCV in this area results in lower neutralizing antibody titers.
1, 43, 44 If anatomically feasible, the full dose of Rabies Immune Globulin (Human) (RIG) should be thoroughly infiltrated in the area around and into the wounds.
Any remaining volume should be injected intramuscularly at a site distant from vaccine administration.
1 Two injections would be given in the gluteal muscle if the volume is greater than 5 mL.
Human Rabies Immune Globulin (HRIG) should never be administered in the same syringe or into the same anatomical site as vaccine.
Because HRIG may partially suppress active production of antibody, no more than the recommended dose should be given.
1, 27 HOW SUPPLIED Imogam® Rabies - HT (rabies immune globulin (human)) is supplied in 2 mL and 10 mL vials with minimal potency of 150 International Units per milliliter (IU/mL).
Vial, 2 mL contains 300 IU which is sufficient for a child weighing 15 kg (33 lb).
Product No.
49281-190-20.
Vial, 10 mL contains a total of 1, 500 IU which is sufficient for an adult weighing 75 kg (165 lb).
Product No.
49281-190-10 Storage Imogam® Rabies - HT (rabies immune globulin (human)) should be stored in the refrigerator between 2° and 8°C (35° and 46°F).
Do not freeze.
Imogam® Rabies - HT (rabies immune globulin (human)) CONTAINS NO PRESERVATIVE AND UNUSED PORTION MUST BE DISCARDED IMMEDIATELY.
REFERENCES 1.
Recommendation of the Advisory Committee on Immunization Practices (ACIP).
Human Rabies prevention - United States, 1999.
MMWR 48:No.
RR-1, 1999 25.
Cabasso VJ, et al.
Rabies immune globulin of human origin: preparation and dosage determination in non-exposed volunteer subjects.
Bull WHO 45:303-315, 1971 26.
Loofbourow JC, et al.
Rabies immune globulin (human).
Clinical trials and dose determination.
JAMA 217:1825-1831, 1971 27.
Helmick CG, et al.
A clinical study of Mérieux human rabies immune globulin.
J Biol Stand 10:357-367, 1982 29.
WHO Expert Committee on Rabies.
WHO Tech Rep Ser 523:50-51, 1973 30.
ACIP.
Human Rabies - California, 1994.
MMWR 43:455-457, 1994 31.
Wilde H, et al.
Failure of Postexposure Treatment of Rabies in Children.
Clin Infect Dis 22:228-232, 1996 32.
Afshar A.
A review of non-bite transmission of rabies virus infection.
Br Vet J 135:142-148, 1979 33.
Winkler WG, et al.
Airborne rabies transmission in a laboratory worker.
JAMA 226:1219-1221, 1973 34.
CDC.
Rabies in a laboratory worker - New York.
MMWR 26:183-184, 1977 35.
Gode GR, et al.
Two rabies deaths after corneal grafts from one donor {letter}.
Lancet 2:791, 1988 43.
World Health Organization.
WHO expert committee on rabies.
WHO Tech Rep Ser 824:1992 44.
Fishbein DB, et al.
Administration of human diploid-cell rabies vaccine in the gluteal area.
N Engl J Med 318:124-125, 1988 Manufactured by: Aventis Pasteur SA, Lyon, France.
Distributed by: Aventis Pasteur Inc.
Swiftwater PA 18370, USA.
1-800-VACCINE (1-800-822-2463) FDA Rev date: n/a
Medication Guide PATIENT INFORMATION No information provided.
Please refer to the WARNINGS and PRECAUTIONS sections.
Medication Guide PATIENT INFORMATION Patients, parents or guardians should be fully informed by their health-care provider of the benefits and risks of administration of Imogam® Rabies – HT (rabies immune globulin (human)) .
Patients, parents or guardians should be instructed to report any serious adverse reactions to their health-care provider.
Overdosage & Contraindications OVERDOSE No information provided.
CONTRAINDICATIONS None known.
Overdosage & Contraindications OVERDOSE No information provided.
CONTRAINDICATIONS Imogam® Rabies – HT (rabies immune globulin (human)) should NOT be administered in repeated doses once vaccine treatment has been initiated.
Repeating the dose may interfere with maximum active immunity expected from the vaccine.
Side Effects & Drug Interactions SIDE EFFECTS Soreness at the site of injection and mild temperature elevations may be observed at times.
Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients.
Angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock have rarely been reported after intramuscular injection, so that a causal relationship between immunoglobulin and these reactions is not clear.
DRUG INTERACTIONS Repeated doses of BayRab (rabies immune globulin (human) solvent/detergent treated) should not be administered once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine.
Other antibodies in the BayRab (rabies immune globulin (human) solvent/detergent treated) preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella.
Therefore, immunization with live vaccines should not be given within 3 months after BayRab (rabies immune globulin (human) solvent/detergent treated) administration.
Side Effects & Drug Interactions SIDE EFFECTS In a recent clinical trial involving 16 volunteers in 4 treatment groups, two subjects reported severe headaches, one in the Imogam® Rabies – HT + placebo group and one in the Imogam® Rabies + Imovax® Rabies group, and one third of the volunteers reported moderate systemic (headache and malaise) reactions.
These were equally distributed among the 4 treatment groups with no significant differences between the groups.
28 Local adverse reactions such as tenderness, pain, soreness or stiffness of the muscles may occur at the injection site and may persist for several hours after injection.
These may be treated symptomatically.
Mild systemic adverse reactions to the globulin after intramuscular injection are uncommon.
28, 38, 39 Although not reported specifically for HRIG, angioneurotic edema, nephrotic syndrome, and anaphylaxis have been reported after injection of immune globulin (IG), a product similar in biochemical composition but without antirabies activity.
These reactions occur so rarely that a causal relationship between IG and these reactions has not been established.
1 Reporting of Adverse Events The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services.
Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine.
40, 41, 42 Reporting by patients, parents or guardians of all adverse events occurring after HRIG administration should be encouraged.
Adverse events following treatment with HRIG should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting Systems (VAERS).
Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.
40, 41, 42 The health-care provider also should report these events to the Director of Scientific and Medical Affairs, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.
DRUG INTERACTIONS Live virus vaccine such as measles vaccines should not be given close to the time of Imogam® Rabies – HT (rabies immune globulin (human)) administration because antibodies in the globulin preparation may interfere with the immune response to the vaccination.
Immunization with live vaccines should not be given within three months after Imogam® Rabies – HT (rabies immune globulin (human)) administration.
REFERENCES 1.
Recommendation of the Advisory Committee on Immunization Practices (ACIP).
Human Rabies prevention – United States, 1999.
MMWR 48:No.
RR-1, 1999 28.
Lang J, et al.
Evaluation of the safety and immunogenicity of a new, heat-treated human rabies immune globulin using a sham, postexposure prophylaxis of rabies.
Biologicals 26:7-15, 1998 38.
Janeway CA, et al.
The gamma globulins.
IV.
Therapeutic uses of gamma globulins.
N Engl J Med 275:826-831, 1966 39.
Kjellman H.
Adverse reactions to human immune serum globulin in Sweden (1969-1978).
pp 143-150.
Immunoglobulins: characteristics and uses of intravenous preparations.
Alving BM and Finlayson JS, Editors.
US Dept.
Health & Human Services, DHHS Publ.
No.
(FDA) 80-9005, Wash.
, DC.
1980 40.
CDC.
Vaccine Adverse Event Reporting System – United States.
MMWR 39:730-733, 1990 41.
CDC.
National Childhood Vaccine Injury Act.
Requirements for permanent vaccination records and for reporting of selected events after vaccination.
MMWR 37:197-200, 1988 42.
Food and Drug Administration.
New Reporting Requirements for Vaccine Adverse Events.
FDA Drug Bull 18(2), 16-18, 1988
Warnings & Precautions WARNINGS Rabies Immune Globulin (Human) — BayRab® is made from human plasma.
Products made from human plasma may contain infectious agents, such as viruses, that can cause disease.
The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.
Despite these measures, such products can still potentially transmit disease.
There is also the possibility that unknown infectious agents may be present in such products.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.
ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Bayer Corporation [1-888-765-3203].
The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.
BayRab (rabies immune globulin (human) solvent/detergent treated) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.
The attending physician who wishes to administer BayRab (rabies immune globulin (human) solvent/detergent treated) to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions.
Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.25 As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.
PRECAUTIONS General BayRab (rabies immune globulin (human) solvent/detergent treated) should not be administered intravenously because of the potential for serious reactions.
Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactoid symptoms.
Pregnancy Category C Animal reproduction studies have not been conducted with BayRab (rabies immune globulin (human) solvent/detergent treated) .
It is also not known whether BayRab (rabies immune globulin (human) solvent/detergent treated) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
BayRab (rabies immune globulin (human) solvent/detergent treated) should be given to a pregnant woman only if clearly needed.
Pediatric Use Safety and effectiveness in the pediatric population have not been established.
REFERENCES 25.
Fudenberg HH: Sensitization to immunoglobulins and hazards of gamma globulin therapy.
In: Merler E (ed.): Immunoglobulins: biologic aspects and clinical uses.
Washington, DC, Nat Acad Sci, 1970, pp 211-20.
Warnings & Precautions WARNINGS Rabies Immune Globulin (Human) USP, Imogam® Rabies – HT, is made from human plasma.
Products made from human plasma may contain infectious agents, such as viruses, that can cause disease.
The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.
An alcohol fractionation procedure used to purify the immunoglobulin component removes and/or inactivates both enveloped and non-enveloped viruses to a certain extent.
An added heat treatment process (60°C, 10 hours) further inactivates both enveloped and non-enveloped viruses.
Despite these measures, it is still theoretically possible that known or unknown infectious agents may be present.
All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health-care provider to the Director of Scientific and Medical Affairs, Aventis Pasteur Inc.
, telephone 1-800-822-2463.
The physician should discuss the risks and benefits of this product with the patient.
Imogam® Rabies – HT (rabies immune globulin (human)) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin.
Persons with specific IgA deficiency have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products containing IgA.
36, 37 PRECAUTIONS General Care is to be taken by the health-care provider for the safe and effective use of this product.
EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THIS PRODUCT.
Imogam® Rabies – HT (rabies immune globulin (human)) should not be administered intravenously because of the potential for serious reactions.
Injection should be made intramuscularly (see DOSAGE AND ADMINISTRATION section for injection procedure) and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel.
Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactoid reactions.
As with all preparations given intramuscularly, bleeding complications may be encountered in patients with bleeding disorders.
Human Rabies Immune Globulin (HRIG) should never be administered in the same syringe or into the same anatomical site as vaccine.
Because HRIG may partially suppress active production of antibody, no more than the recommended dose should be given.
1, 27 A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis or other infectious agents from person to person.
Needles should not be recapped and should be disposed of according to biohazard waste guidelines.
Pregnancy Reproductive Studies – Pregnancy Category C Animal reproduction studies have not been conducted with Imogam® Rabies – HT (rabies immune globulin (human)) .
It is also not known whether Imogam® Rabies – HT (rabies immune globulin (human)) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Imogam® Rabies – HT (rabies immune globulin (human)) should be given to a pregnant woman only if clearly needed.
REFERENCES 1.
Recommendation of the Advisory Committee on Immunization Practices (ACIP).
Human Rabies prevention – United States, 1999.
MMWR 48:No.
RR-1, 1999 27.
Helmick CG, et al.
A clinical study of Mérieux human rabies immune globulin.
J Biol Stand 10:357-367, 1982 36.
Fudenberg HH.
Sensitization to immunoglobulins and hazards of gamma globulin therapy, pp 211-220 in Merler E, Editor Immunoglobulins:biologic aspects and clinical uses.
National Academy of Sciences, Wash.
, DC.
1970 37.
Pineda AA, et al.
Transfusion reactions associated with anti-lgA antibodies: report of four cases and review of the literature.
Transfusion 15:10-15, 1975
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