Indications and Usage
VARILRIX is indicated for active immunisation against varicella of healthy subjects from 9 months of age. Groups who would particularly benefit from vaccination include:
- Non-immune adults, especially those in at-risk occupations such as health care workers, teachers and workers in children’s day-care centres
- Non-immune parents of young children
- Non-immune household contacts, both adults and children, of immunocompromised patients
Dosage and Administration
VARILRIX should be administered as a single dose by subcutaneous injection only. The upper arm (deltoid region) is the preferred site of injection. UNDER NO CIRCUMSTANCES SHOULD VARILRIX BE ADMINISTERED INTRAVENOUSLY. VARILRIX should not be administered intradermally.
Dosage Forms and Strengths
Infants and Children (aged 9 months up to and including 12 years of age) – A single 0.5ml reconstituted dose of VARILRIX is used for immunisation of infants and children.
Adolescents and Adults (13 years of age and over) – Two 0.5ml doses of reconstituted VARILRIX, administered at least 6 weeks apart, are required.
- VARILRIX should not be administered to subjects with known hypersensitivity to any component of the vaccine.
- VARILRIX is contraindicated in subjects with known systemic hypersensitivity to neomycin, but a history of contact dermatitis to neomycin is not a contraindication.
- VARILRIX is contraindicated during pregnancy. Pregnancy should be avoided for three months after vaccination
- Individuals receiving immunosuppressive therapy are more susceptible to infections than healthy individuals. Vaccination with live attenuated varicella vaccine can result in a more extensive vaccine associated rash or disseminated disease in individuals on immunosuppressant doses of corticosteroids.
- Individuals with primary and acquired immunodeficiency states, including those who are immunosuppressed in association with AIDS or other clinical manifestations of infections with human immunodeficiency virus; cellular immune deficiencies; hypogammaglobulinemic and dysgammaglobulinemic states; leukaemias, lymphomas and blood dyscrasias.
- A family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
- As with other vaccines, the administration of VARILRIX should be postponed in subjects suffering from acute severe febrile illness. In healthy subjects, the presence of a minor infection, however, is not a contraindication to immunisation.
Warnings and Precaution
- VARILRIX should under no circumstances be administered intravenously. VARILRIX should not be administered intradermally.
- As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of a vaccine.
- Transmission of the Oka virus to seronegative contacts of a vaccinee has been shown to occur at an extremely low rate. Transmission has not been reported if the vaccinee does not have vaccine-associated cutaneous lesions. The mild nature of the rash which developed in the healthy contacts indicates that the virus remains attenuated after passage through human hosts.
- Vaccine recipients should attempt to avoid contact with susceptible high risk individuals for up to 6 weeks, where possible.
- As for any vaccine, vaccination with Varilrix may not result in protection from subsequent infection with varicella virus in 100% of subjects.
- The safety and efficacy of Varilrix has not been established in persons who are known to be infected with HIV, with or without evidence of immunosuppression.
- The duration of protection from varicella infection with Varilrix is unknown. The need for and timing of booster doses is uncertain at present. In a highly vaccinated population, immunity of some individuals may wane due to lack of exposure to natural varicella as a result of shifting epidemiology.
- It is not known whether Varilrix given immediately after exposure to wild varicella virus will prevent illness. Results of a small household contact study using another live varicella virus vaccine containing the same varicella strain as Varilrix suggested that some protection was provided by that vaccine when vaccination occurred within 72 hours of exposure.
- There are inadequate data to assess the incidence and severity of herpes zoster (shingles) after vaccination with Varilrix.
- Pain at the injection site was usually described as mild, and swelling and redness >2cm in diameter were infrequently observed.
- No serious adverse events were considered to be unequivocally related to vaccination.
Use in Specific Populations
- VARILRIX use is contraindicated in pregnant women as the possible effects on foetal development are unknown. Pregnancy should be avoided for three months after vaccination.
- The effect on breast fed infants of the administration of VARILRIX to their mothers has not been evaluated in clinical studies.
- VARILRIX should not be mixed in the same syringe with other vaccines. Different injection sites should always be used.