A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Imogam Rabies Side Effects, and Drug Interactions - Rabies Immune Globulin (Human)
Imogam Rabies Side Effects, and Drug Interactions - Rabies Immune Globulin (Human)
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. 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.
DRUG INTERACTIONS
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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