Hepatitis A Vaccine
Hepatitis A Vaccine
Hepatitis A Vaccine
DESCRIPTION:
Intramuscular vaccine
Used for protection against hepatitis A
Ideally, immunization should occur between 12 to 23 months of
age
DOSING CONSIDERATIONS:
Hepatic Impairment
Specific guidelines for dosage adjustments in hepatic impairment are not
available; it appears that no dosage adjustments are needed.
Renal Impairment
Specific guidelines for dosage adjustments in renal impairment are not
available; it appears that no dosage adjustments are needed.
ADMINISTRATION:
Injectable Administration
Inactivated hepatitis A vaccine is administered intramuscularly; do not
inject intravenously, intradermally, or subcutaneously.
Visually inspect parenteral products for particulate matter and
discoloration prior to administration. After agitation, the injection should
appear as an opaque, white, homogenous suspension. Discard if it appears
otherwise.
Intramuscular Administration
Preparation:
The vaccine should be used as supplied; no dilution or reconstitution is
necessary.
Shake vigorously just prior to administration. With through agitation,
Harvix is a homogenous, turbid white suspension, and Vaqta is a slightly
opaque, white suspension. If the vaccine cannot be resuspended or the
appearance is not as described, discard it.
Do not mix with any other vaccine or immune globulin.
Storage of unopened vials:
Manufacturer recommendations: Store refrigerated at 2—8 degrees C (36
to 46 degrees F); do not freeze.
Off-label storage information: According to a 2007 published article,
storage of Havrix (GlaxoSmithKline) at room temperature for up to 72
hours is acceptable, and Vaqta (Merck) can be stored at 37 degrees C
(98.6 degrees F) for up to 12 months. Other sources suggest that Havrix
(GlaxoSmithKline) may maintain stability for up to 3 weeks at 37 degrees
C. NOTE: Because changes in vaccine formulation can affect stability
and effectiveness, confirmation of acceptable duration of storage at room
temperature directly from the manufacturer for the specific vaccine being
administered is recommended.
Fever, infection
The decision to administer or to delay vaccination with the hepatitis A
vaccine, inactivated because of current or recent febrile illness depends
on the severity of symptoms and on the etiology of the disease. The
Advisory Committee on Immunization Practices recommends that
vaccinations be delayed during the course of a moderate or severe acute
febrile illness and administered after the acute phase of illness has
resolved, unless the patient is at immediate risk of hepatitis A infection
Pregnancy
No adequate and well-controlled studies have been conducted with the
hepatitis A vaccine, inactivated during pregnancy. In pre- and
post-licensure clinical studies and post-approval reports, pregnant women
who were administered hepatitis A vaccine, inactivated had rates of
miscarriage and major birth defects that were consistent with estimated
background rates.
ADVERSE REACTIONS:
Severe
seizures / Delayed / 0-1.0
Guillain-Barre syndrome / Delayed / Incidence not known
aluminum toxicity / Delayed / Incidence not known
myelitis / Delayed / Incidence not known
anaphylactic shock / Rapid / Incidence not known
vasculitis / Delayed / Incidence not known
angioedema / Rapid / Incidence not known
serum sickness / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
erythema multiforme / Delayed / Incidence not known
Moderate
erythema / Early / 21.2-21.2
constipation / Delayed / 0-10.0
lymphadenopathy / Delayed / 0-1.0
hypertonia / Delayed / 0-1.0
photophobia / Early / 0-1.0
wheezing / Rapid / 0-1.0
peripheral neuropathy / Delayed / Incidence not known
encephalopathy / Delayed / Incidence not known
dyspnea / Early / Incidence not known
thrombocytopenia / Delayed / Incidence not known
Mild
injection site reaction / Rapid / 18.2-67.0
irritability / Delayed / 2.8-33.3
drowsiness / Early / 20.8-22.3
headache / Early / 0-16.1
fever / Early / 1.0-12.4
fatigue / Early / 1.0-10.0
malaise / Early / 1.0-10.0
vomiting / Early / 0-10.0
anorexia / Delayed / 1.0-10.0
nausea / Early / 1.0-10.0
insomnia / Early / 0-10.0
myalgia / Early / 0-5.0
diarrhea / Early / 0-4.6
chills / Rapid / 0-1.3
abdominal pain / Early / 0-1.2
arthralgia / Delayed / 0-1.0
dysgeusia / Early / 0-1.0
vertigo / Early / 0-1.0
pruritus / Rapid / 0-1
MECHANISM OF ACTION: