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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.
Read the Imogam Rabies (rabies immune globulin (human)) Side Effects Center for a complete guide to possible side effects
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.
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, 1988This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/23/2008
Additional Imogam Rabies Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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