Administration
VARIVAX is for subcutaneous administration. The outer
aspect of the upper arm (deltoid) is the preferred site
of injection.
Use only diluent supplied, since it is free
of preservatives
or other antiviral substances that might inactivate the
vaccine virus.
To reconstitute the vaccine, first withdraw
0.7 mL of diluent into a syringe. Inject all the diluent
in
the syringe into
the vial of lyophilized vaccine and gently agitate
to mix thoroughly. Withdraw the entire contents into
a
syringe and
inject the total volume (about 0.5 mL) of reconstituted
vaccine subcutaneously, preferably into the outer
aspect of the
upper arm (deltoid) or the anterolateral thigh.
IT IS
RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY
AFTER RECONSTITUTION TO MINIMIZE LOSS OF
POTENCY; DISCARD
IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.
Indications and Dosing
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, 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.1 |
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).
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 Prescribing
Information and
Patient
Product Information.
|
