Zostavax Special Precautions

vaccine, varicella-zoster




Zuellig Pharma
Full Prescribing Info
Special Precautions
The health care provider should question the patient about reactions to a previous dose of any VZV-containing vaccines (see Contraindications).
As with any vaccine, adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.
Deferral of vaccination should be considered in the presence of fever >38.5°C (>101.3°F).
The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with human immunodeficiency virus (HIV), with or without evidence of immunosuppression. A phase II safety and immunogenicity study in HIV-infected adults with conserved immune function has been completed (see Pharmacology: Special Populations under Actions and Side Effects).
As with any vaccine, vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.
Transmission: 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. 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 to a susceptible individual should be weighed against the risk of developing natural zoster that could be transmitted to a susceptible individual.
Use in Children: ZOSTAVAX is not recommended for use in this age group.
Use in the Elderly: The mean age of subjects enrolled in the largest (N=38,546) clinical study of ZOSTAVAX was 69 years (range 59-99 years). Of the 19,270 subjects who received ZOSTAVAX, 10,378 were 60-69 years of age, 7,629 were 70-79 years of age and 1,263 were 80 years of age or older. ZOSTAVAX was demonstrated to be generally safe and effective in this population.
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