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. ³⁰

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. ^30,40,41

Although not reported specifically for HRIG, angioneurotic edema, nephrotic syndrome, and anaphylaxis have been reported after injection of immune globulin (IG). These reactions occur so rarely that a causal relationship between IG and these reactions is not clear. 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. ^42,43,44

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. ^42,43,44

The health-care provider also should report these events to the Director of Medical Affairs, Connaught Laboratories, Inc., Route 611, PO Box 187, Swiftwater, PA 18370 or call 1-800-822-2463.

Live virus vaccine such as measles vaccines should not be given close to the time of IMOGAM ^® RABIES† HT 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 administration.

Pregnancy

REPRODUCTIVE STUDIES — PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with IMOGAM ^® RABIES - HT. It is also not known whether IMOGAM ^® RABIES - HT can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. IMOGAM ^® RABIES - HT should be given to a pregnant woman only if clearly needed.

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