Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
Please refer to the Summary of Product Characteristics for full prescribing information.
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic/anaphylactoid reaction following the administration of the vaccine, as there is a possibility of hypersensitivity reactions, not only to the active substances, but also to the excipients and trace residuals (e.g. neomycin) present in the vaccine.
Neomycin allergy generally manifests as a contact dermatitis. However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.
ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration to individuals who are immunosuppressed or immunodeficient may result in disseminated varicella-zoster virus disease, including fatal outcomes. Patients who previously received immune suppressive therapy should be carefully evaluated for the reconstitution of the immune system prior to receiving ZOSTAVAX.
The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression however, a Phase II safety and immunogenicity study in HIV-infected adults with conserved immune function (CD 4+T cell count ≥200 cells/µL) has been completed.
This vaccine should be given subcutaneously to individuals with severe thrombocytopenia or any coagulation disorder, because these individuals may bleed following intramuscular injections.
ZOSTAVAX is not indicated for treatment of zoster or post-herpetic neuralgia (PHN).
Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection.
As for any vaccine, vaccination with ZOSTAVAX may not result in protection in all vaccine recipients.
In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported. However, post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between vaccinees who develop a varicella-like rash and susceptible contacts (for example, varicella-zoster virus [VZV] susceptible infant grandchildren). Transmission of vaccine virus from varicella vaccine recipients who do not develop a varicella-like rash has also been reported. This is a theoretical risk for vaccination with ZOSTAVAX. The risk of transmitting the attenuated vaccine virus from a vaccinee to a susceptible contact should be weighed against the risk of developing natural zoster and potentially transmitting wild-type VZV to a susceptible contact.
ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites.
The concomitant use of ZOSTAVAX and a 23-valent pneumococcal polysaccharide vaccine resulted in reduced immunogenicity of ZOSTAVAX in a small clinical trial. However, data collected in a large observational study did not indicate increased risk for developing herpes zoster after concomitant administration of the two vaccines.
No data are currently available regarding concomitant use with other vaccines.
Concurrent administration of ZOSTAVAX and anti-viral medications known to be effective against VZV has not been evaluated.
There are no data on the use of ZOSTAVAX in pregnant women. However naturally-occurring varicella-zoster virus infection is known to sometimes cause foetal harm. ZOSTAVAX is not recommended to be administered to pregnant women. In any case, pregnancy should be avoided for one month following vaccination.
It is unknown whether varicella-zoster virus is secreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to not administer ZOSTAVAX taking into account the benefit of breastfeeding for the child and the benefit of vaccination for the woman.
Please refer to the Summary of Product Characteristics for full prescribing information.
Frequency | Side effects of ZOSTAVAX |
Very common side effects (≥1/10) |
Injection site:
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Common side effects (≥1 /100 to <1 /10 ) |
Injection site:
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A full list of side effects can be found in the Summary of Product Characteristics and the Patient Information Leaflet.
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Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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GB-CIN-00388 | Date of Preparation: July 2022