ZOSTAVAX is contraindicated in
persons with a history of anaphylactic/
anaphylactoid reaction
to gelatin, neomycin, or any other component of the vaccine;
with a history of primary or acquired immunodeficiency states
including leukemia; lymphomas of any type, or other malignant
neoplasms affecting the bone marrow or lymphatic system; or
with AIDS or other clinical manifestations of infection with
human immunodeficiency viruses. ZOSTAVAX is a live attenuated
varicella-zoster vaccine and administration may result in disseminated
disease in individuals who are immunosuppressed. ZOSTAVAX is
also contraindicated in persons on immunosuppressive therapy.
ZOSTAVAX is not indicated
in women of childbearing age and should not be administered
to pregnant females.
> Read Select Safety Information for ZOSTAVAX
Identify, recommend, and vaccinate appropriate
patients with ZOSTAVAX.
- ZOSTAVAX is a single-dose, subcutaneous
vaccine.
- Vaccinate appropriate patients during annual physicals,
regular checkups, or at other appropriate opportunities all year round.
- The immunogenicity of ZOSTAVAX and trivalent
inactivated flu vaccine
(TIV) has been measured in a concomitant-use clinical study.
In a clinical study in which subjects received ZOSTAVAX either
concurrently with or 4 weeks after TIV, antibody responses to
both vaccines were similar in each group.a
aAntibody responses were measured
at 4 weeks postvaccination in a double-blind, controlled
study
in which a substudy of 374 adults in the United States, 60
years of age
and older (median age=66 years), were randomized to receive TIV and ZOSTAVAX
concurrently (N=188),
or TIV alone followed 4 weeks later by ZOSTAVAX alone (N=186).
A well-studied vaccine
- ZOSTAVAX is a live attenuated virus vaccine indicated
for prevention of herpes zoster in individuals 60 years
of age and older. ZOSTAVAX is not indicated for the treatment
of zoster or postherpetic neuralgia.
- ZOSTAVAX
has been evaluated for safety in more than 20,000 adults.
Before administering
ZOSTAVAX, please read the Prescribing
Information and Patient
Product Information.
About ZOSTAVAX
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes
zoster (shingles) in individuals 60 years of age and older.
ZOSTAVAX is not
indicated for the treatment of zoster or postherpetic neuralgia.
Select Safety Information
Vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.
ZOSTAVAX
is contraindicated in persons with a history of anaphylactic/anaphylactoid
reaction to gelatin, neomycin, or any other component of the vaccine; with
a history of primary or acquired immunodeficiency states including leukemia;
lymphomas of any type, or other malignant neoplasms affecting the bone marrow
or lymphatic system; or with AIDS or other clinical manifestations of infection
with human immunodeficiency viruses. ZOSTAVAX is a live attenuated varicella-zoster
vaccine and administration may result in disseminated disease in individuals
who are immunosuppressed. ZOSTAVAX is also contraindicated in persons on
immunosuppressive therapy. ZOSTAVAX is not indicated in women of childbearing
age and should not be administered to pregnant females.
Vaccine-related, injection-site
and systemic adverse experiences in >1% of individuals in the Adverse Event
Monitoring Substudy (AEMS), a subgroup of
individuals from the Shingles Prevention Study (SPS) who received ZOSTAVAX
(n=3,345), included headache (1.4%) and the following injection-site reactions:
erythema (33.7%), pain/tenderness (33.4%), swelling (24.9%), hematoma (1.4%),
pruritus (6.6%), and warmth (1.5%). Most of these adverse experiences were
reported as mild in intensity.
From Day 0 to 42 postvaccination, in the overall
study population, serious adverse experiences (SAEs) occurred at a similar
rate (1.4%) in subjects vaccinated
with ZOSTAVAX or placebo. In the AEMS, the rate of SAEs was increased in the
group who received ZOSTAVAX (1.9%) as compared to the placebo group (1.3%)
from Day 0 to 42 postvaccination. Over the course of the entire study, in the
overall study population, investigator-determined, vaccine-related serious
adverse experiences were reported for 2 subjects vaccinated with ZOSTAVAX (asthma
exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo
(Goodpasture’s syndrome, anaphylactic reaction, and polymyalgia rheumatica).
Among
reported serious adverse events in the SPS (Days 0–42 postvaccination),
serious cardiovascular events occurred more frequently in subjects who received
ZOSTAVAX (20 [0.6%]) than in subjects who received placebo (12 [0.4%]) in the
AEMS. The frequencies of serious cardiovascular events were similar in subjects
who received ZOSTAVAX (81 [0.4%]) and in subjects who received placebo (72
[0.4%]) in the entire SPS study cohort (Days 0–42 postvaccination).
Transmission
of vaccine virus may occur rarely between vaccinees and susceptible contacts.
ZOSTAVAX
is not indicated for prevention of primary varicella infection (Chickenpox).
Before administering ZOSTAVAX, please read the Prescribing Information and Patient Product Information.
ZOSTAVAX is a registered trademark of Merck & Co., Inc.
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