Hepatitis A vaccine

DESCRIPTION:
Intramuscular vaccine
Used for protection against hepatitis A
Ideally, immunization should occur between 12 to 23 months of
age

COMMON BRAND NAMES:

Havrix, Vaqta

DOSAGE & INDICATIONS:

For hepatitis A prophylaxis.
For primary immunization (Havrix or Vaqta).
Intramuscular dosage
Adults >= 19 years of age
1 mL/dose IM followed by a 1 mL booster dose at least 6 months after
the first dose. After the first dose, the ACIP recommends series
completion within 18 months; the manufacturer of Havrix recommends
series completion within 1 year.
Adults 18 years of age, Adolescents, and Children
0.5 mL/dose IM ideally given at 12 to 23 months of age, followed by a
0.5 mL/dose booster dose at least 6 months after the first dose. After the
first dose, the ACIP recommends series completion within 18 months; the
manufacturer of Havrix recommends series completion within 1 year.
Catch-up vaccination may occur in patients 2 years and older, with doses
separated by 6 to 18 months.

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.

Intramuscular (IM) injection:

A separate syringe and needle should be used for each person receiving
hepatitis A vaccine, inactivated.
Aspirate prior to injection to avoid injection into a blood vessel. Inject
into the deltoid muscle of the upper arm. Do not inject into the gluteal
region as this may result in a suboptimal response.
When concomitant administration of other vaccines or immunoglobulin is
required, they should be given with different syringes and at different
injection sites.
CONTRAINDICATIONS / PRECAUTIONS:

Latex hypersensitivity, neomycin hypersensitivity

Hepatitis A vaccine, inactivated is contraindicated in patients who have
had a severe allergic reaction (e.g., anaphylaxis) temporally associated
with a previous dose of this vaccine or hypersensitivity to any of its
components. Use of this vaccine is contraindicated in patients with a
neomycin hypersensitivity; the vaccines contain a residual amount of
neomycin from the manufacturing process. Patients who develop
symptoms suggestive of hypersensitivity should not receive further
injections of the vaccine.

Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia,

vitamin K deficiency
Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy
(e.g., hemophilia), or receiving anticoagulant therapy should be
monitored closely when given hepatitis A vaccine, inactivated because
bleeding can occur at the IM injection site. The vaccine should be given
only if the potential benefits clearly outweigh the risk of administration

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:

njection of hepatitis A vaccine produces antibodies that confer

protection against hepatitis A infection. Stimulation of
specific antibodies takes place without producing any disease
symptoms. During the course of natural infection with the
hepatitis A virus, the initial antibody response is
predominantly of the IgM class. This response lasts for several
months, but during convalescence antibodies of the IgG class
become dominant. Patients with anti-HAV of the IgG class are
immune to reinfection. The IgG antibodies remain detectable
indefinitely. Two years after immunization with hepatitis A
vaccine IgG levels remained relatively high in the serum of
immunized patients. The duration of protection from a course
of hepatitis A vaccine is as yet unknown. Long term follow-up
studies will determine the necessity for booster doses of HAV.