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Zostavax (Zoster Vaccine Live) - Warnings and Precautions

 
 



WARNINGS AND PRECAUTIONS

Transmission of Vaccine Virus

Transmission of vaccine virus may occur rarely between vaccinees and susceptible contacts.

Primary Varicella Disease

ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).

Preventing and Managing Allergic Vaccine Reactions

As with any vaccine, adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.

Limitations of Vaccine Effectiveness

The duration of protection beyond 4 years after vaccination with ZOSTAVAX is unknown. The need for revaccination has not been defined.

Vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.

Concurrent Illness

Vaccination should be deferred in patients with active untreated tuberculosis. Deferral should be considered in acute illness, for example, in the presence of fever.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with ZOSTAVAX. It is also not known whether ZOSTAVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, naturally occurring VZV infection is known to sometimes cause fetal harm. ZOSTAVAX is not indicated in women of child-bearing age and should not be administered to pregnant females.

Vaccinees and health care providers are encouraged to report any exposure to ZOSTAVAX during pregnancy by calling (800) 986-8999.

Nursing Mothers

ZOSTAVAX is not indicated in women who are nursing. It is not known whether VZV is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if ZOSTAVAX is administered to a nursing woman.

Pediatric Use

ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox) and should not be used in children and adolescents.

Geriatric Use

The median 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.

Page last updated: 2009-07-27

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