For the prevention of varicella in persons 12 months and older

Vaccine; Vaccine, Live (Viral)

Onset of action: Seroconversion occurred in 97% of healthy children ~4 to 6 weeks following a one dose regimen; using a two dose regimen, the seroconversion rate was 99.9% 6 weeks after the second dose. In adolescents?13 years of age and adults, the seroconversion rate was ~75% 4 weeks after the first dose and 99% 4 weeks after the second dose Duration: Antibody titers detectable at 10 years postvaccination. Actual antibody titers vary by year and age group, but are ~99% to 100% for children at 10 years and 100% for adolescents and adults at 6 years postvaccination. Exposure to wild-type varicella may boost antibody levels.

Severe allergic or anaphylactic reaction to the vaccine, neomycin, gelatin, or any component of the formulation; immunosuppressed or immunodeficient individuals including individuals with leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; persons with AIDs or other clinical manifestations of HIV; those receiving immunosuppressive therapy (including immunosuppressive doses of corticosteroids); history of primary and acquired immunodeficiency states; active, untreated tuberculosis; current febrile illness (per manufacturer labeling); pregnancy Canadian labeling: Additional contraindications (not in US labeling): Varivax III: Family history of congenital or hereditary immunodeficiency (unless immune competence of vaccine recipient is demonstrated); Varilrix: Primary or acquired immunodeficiency with a total lymphocyte count <1,200/mm3

C Varicella virus vaccine is contraindicated for use in pregnant females and pregnancy should be avoided for 3 months (per manufacturer labeling; 1 month per ACIP) following vaccination.

It is not known if varicella virus vaccine is present in breast milk. Guidelines note that immunization should not be delayed due to breastfeeding and vaccinated women may continue to breastfeed (CDC/ACIP [Marin 2007]).

Common Dermatologic: Injection site reaction (19.3% to 32.5% ), Rash, Varicella-like (0.9% to 5.5% ) Other: Fever (9.5% to 14.7% ) Serious Dermatologic: Stevens-Johnson syndrome, Toxic epidermal necrolysis Hematologic: Thrombocytopenic purpura Immunologic: Anaphylaxis, Herpes zoster ophthalmicus Neurologic: Encephalitis, Febrile seizure (Less than 0.1% )

Varicella immunization: SubQ: US labeling: Two doses of 0.5 mL separated by ?4 weeks (4 to 8 weeks apart per ACIP). Note: The ACIP recommends that all children and adults without evidence of immunity receive 2 doses of the vaccine; those who received only 1 dose of a varicella-containing vaccine receive a second dose (CDC/ACIP [Marin 2007]). Postexposure prophylaxis (healthy, previously unvaccinated individuals) (off-label use): SubQ: 0.5 mL administered ideally within 72 hours postexposure but may be used up to 120 hours (5 days) postexposure (CDC/ACIP [Marin 2007])

Children ?12 months: 0.5 mL; a second dose may be administered ?3 months later Adolescents ?13 years: Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling.

There are no dosage adjustments provided in the manufacturer's labeling.

store between 2-8 degree C