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
Rabavert Side Effects, and Drug Interactions - Rabies Vaccine
Rabavert Side Effects, and Drug Interactions - Rabies Vaccine
SIDE EFFECTS
SEE ALSO WARNINGS AND CONTRAINDICATIONS
SECTIONS FOR ADDITIONAL STATEMENTS
Local reactions such as
induration, swelling
and reddening have been reported more often than systemic
reactions. In a comparative
trial in normal volunteers, Dreesen et al. (3, 24) described
their experience with RabAvert compared to a HDCV
rabies vaccine. Nineteen
subjects received RabAvert and 20 received HDCV. The most commonly
reported adverse reaction was pain
at the injection site,
reported in 45% of the HDCV
group, and 34% of the RabAvert group. Localized lymphadenopathy
was reported in about 15% of each group. The most common systemic
reactions were malaise
(15% RabAvert group vs.
25% HDCV group), headache
(10 % RabAvert group vs.
20 % HDCV group), and dizziness
(15% RabAvert group vs.
10 % HDCV group). In a
recent study in the USA (4), 83 subjects received RabAvert and 82
received HDCV. Again, the most common adverse reaction
was pain at the injection
site in 80% in the HDCV
group and 84% in the RabAvert
group. The most common systemic
reactions were headache
(52% RabAvert group vs.
45% HDCV group), myalgia
(53% RabAvert group vs.
38% HDCV group) and malaise
(20% RabAvert group vs.
17% HDCV group). None of
the adverse events was serious, almost all adverse events were of
mild or moderate intensity. Statistically significant
differences between vaccination
groups were not found. Both vaccines were generally well tolerated.
Uncommonly observed adverse events include temperatures above 38°C
(100°F), swollen lymph
nodes, and gastrointestinal
complaints. In rare cases,
patients have experienced severe headache,
fatigue, circulatory
reactions, sweating, chills, monoarthritis and allergic
reactions; transient paresthesias and one case
of suspected urticaria
pigmentosa have also been reported. Type III hypersensitivity
reactions in pre-exposure booster
immunizations have been reported with one HDCV
rabies vaccine
(25-27). These reactions are thought to be due to small amounts
of human serum
albumin (HSA) rendered
allergenic by propiolactone
(23, 28, 29). Human serum
albumin (HSA) is present
in RabAvert at concentrations less than 0.3 µg/dose. No
type III hypersensitivity
reactions have been observed with RabAvert (30).
Serious systemic anaphylactic
reactions or neuroparalytic events have been reported in association
with RabAvert administration. Against a background of 11.8 million
doses distributed world-wide 10 cases of encephalitis
(1 death) or meningitis,
7 cases of transient
paralysis including
2 cases of Guillain-Barre Syndrome, 1 case
of myelitis, 1 case of
retrobulbar neuritis,
and 2 cases of suspected multiple
sclerosis have been
temporally associated with the use of RabAvert. Also, 2 cases of
anaphylactic shock have
been reported. A patient's risk
of developing rabies
must be carefully considered, however, before deciding to discontinue
immunization (see
WARNINGS).
The use of corticosteroids to treat life-threatening neuroparalytic
reactions may inhibit the development
of immunity to rabies
(see PRECAUTIONS, DRUG
INTERACTIONS).
Once initiated, rabies
prophylaxis should
not be interrupted or discontinued because of local
or mild systemic adverse
reactions to rabies vaccine.
Usually such reactions
can be successfully managed with anti-inflammatory and antipyretic
agents.
Reporting of Adverse Events
Adverse events should be reported by the health
care provider or patient
to the US Department of Health and Human Services (DHHS) Vaccine
Adverse Event Reporting System (VAERS). Report forms and information
about reporting requirements or completion of the form
can be obtained from VAERS by calling the toll-free number
1-800-822-7967 (26). In the
USA, such events can be
reported to the Professional Services department, Chiron Corporation:
phone: 1-888-CHIRON-7.
DRUG INTERACTIONS
Corticosteroids, other immunosuppressive agents, antimalarials
and immunosuppressive illnesses can interfere with the development
of active immunity
after vaccination, and may diminish the protective
efficacy of the vaccine.
Pre-exposure prophylaxis should be administered to such
persons with the awareness that the immune response may be inadequate.
Immunosuppressive agents should not be administered during post-exposure
therapy unless essential
for the treatment
of other conditions. When rabies
post-exposure prophylaxis
is administered to persons receiving corticosteroids or other immunosuppressive
therapy, or who are
immunosuppressed, it is important that a serum
sample be tested for
rabies antibody to ensure that an acceptable antibody
response has been induced
(23).
Rabies Immuno Globulin must not be administered at more than the
recommended dose, since response
to active immunization
may be impaired.
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