VARIVAX is indicated for vaccination against
varicella in individuals 12 months of age and
older.
Children 12 months to 12 years of age should
receive a 0.5-mL dose administered subcutaneously;
if a second 0.5-mL dose is administered to children,
it should be given a minimum of 3 months later.
Adolescents
and adults 13 years of age and older should
receive a 0.5-mL dose administered subcutaneously
at
elected date and a second 0.5-mL dose 4 to
8 weeks later.
Select Safety Information
VARIVAX is contraindicated in certain individuals,
including those with: a history of hypersensitivity
to any component of the vaccine, including gelatin;
a history of anaphylactoid reaction to neomycin;
blood dyscrasias, leukemia, lymphomas of any
type, or other malignant neoplasms affecting
the bone marrow or lymphatic systems; an immunodeficient
condition or receiving immunosuppressive therapy;
active, untreated tuberculosis; active febrile
illness; or those who are pregnant.
In children, adolescents, and adults monitored
for up to 42 days, the adverse effects most frequently
reported were as follows: fever, injection-site
complaints, varicella-like rash (injection site),
and
varicella-like rash (generalized).
In a clinical trial involving children who received
2 doses of VARIVAX 3 months apart, the incidence
of injection-site clinical complaints (primarily
erythema and swelling) observed in the first
4 days following vaccination was slightly higher
post-dose 2 (overall incidence 25.4%) than post-dose
1 (overall incidence 21.7%), whereas the incidence
of systemic clinical complaints in the 42-day
follow-up period was lower post-dose 2 (66.3%)
than post-dose 1 (85.8%).
The duration of protection of VARIVAX is unknown;
however, long-term efficacy studies have demonstrated
continued protection up to 10 years after vaccination.
Vaccination with VARIVAX may not result in protection
of all healthy, susceptible children, adolescents,
and adults.
Before administering VARIVAX, please read the
accompanying Prescribing
Information.
VARIVAX is a registered
trademark of Merck & Co.,
Inc.