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Included as part of the PRECAUTIONS section.

Hypersensitivity Reactions

Serious adverse reactions, including anaphylaxis, have occurred with ZOSTAVAX. Adequate treatment provisions, including epinephrine injection (1:1,000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.

Transmission of Vaccine Virus

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

Concurrent Illness

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

Limitations of Vaccine Effectiveness

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

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

Patient Counseling Information

[See FDA-Approved Patient Labeling.]

• Question the patient about reactions to previous vaccines.
• Provide a copy of the patient information (PPI) located at the end of this insert and discuss any questions or concerns.
• Inform patient of the benefits and risks of ZOSTAVAX, including the potential risk of transmitting the vaccine virus to susceptible individuals, such as immunosuppressed or immunodeficient individuals or pregnant women who have not had chickenpox.
• Instruct patient to report any adverse reactions or any symptoms of concern to their healthcare professional.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

ZOSTAVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category: Contraindication [see CONTRAINDICATIONS].

Vaccinees and health care providers are encouraged to report any exposure to ZOSTAVAX during pregnancy by calling 1-800-986-8999.

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.

Last reviewed on RxList: 7/25/2011
This monograph has been modified to include the generic and brand name in many instances.