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The physicians should interview a recipient on post-vaccination experiences of live, attenuated varicella virus vaccine, before administrating SKYZoster.
SKYZoster should be administered only for prevention of herpes zoster (shingles) in individuals aged 50 years and older.
SKYZoster is not indicated for prevention of primary varicella infection (Chickenpox).
SKYZoster should be administered only to a recipient who can induce an adequate immune response.
SKYZoster is not indicated for treatment of zoster or post-herpetic neuralgia.
As with other vaccines, serious adverse reactions, including anaphylaxis, might occur with SKYZoster. Adequate treatment provisions, including epinephrine injection (1:1,000), should be available for immediate use.
Deferral should be considered in acute illness (for example, in the presence of fever, > 38.0°C).
As with other vaccines, vaccination with SKYZoster does not result in protection of all vaccine recipients.
Effectiveness of the multiple-dose of SKYZoster has not been evaluated. The need for a boost dose is not defined.
Transmission of the vaccine virus has not been reported from SKYZoster clinical studies. However with live, attenuated varicella-zoster virus vaccines, transmission of vaccine virus may occur rarely between vaccinees with breakthrough infections and susceptible contacts.
No studies on the effects on the ability to drive or use machines have been performed.
Use in Children: SKYZoster is not indicated for prevention of primary varicella infection (Chickenpox) and should not be used in children and adolescents.
Use in the Elderly: The median age of subjects enrolled in the clinical studies (N=845), whom were administrated with SKYZoster, was 59 years (range 50~82 years). Of the subjects, 440 were 50~59 years of age, 298 were 60-69 years of age and 107 were 70 years and older. A total number of elderly subjects over 65 years of age was 229.
