ZOSTAVAX is contraindicated in persons with a history of anaphylactic/
anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; with a history of primary or acquired immunodeficiency states including leukemia; lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; or with AIDS or other clinical manifestations of infection with human immunodeficiency viruses. ZOSTAVAX is also contraindicated in persons on immunosuppressive therapy. ZOSTAVAX is not indicated in women of childbearing age and should not be administered to pregnant females.

> Read Select Safety Information for ZOSTAVAX

Identify, recommend, and vaccinate appropriate patients with ZOSTAVAX.

• ZOSTAVAX is a single-dose, subcutaneous vaccine.
• Vaccinate appropriate patients during annual physicals, regular checkups, or at other appropriate opportunities all year round.
• The immunogenicity of ZOSTAVAX and trivalent inactivated flu vaccine (TIV) has been measured in a concomitant-use clinical study.

In a clinical study in which subjects received ZOSTAVAX either concurrently with or 4 weeks after TIV, antibody responses to both vaccines were similar in each group.^a

^aAntibody responses were measured at 4 weeks postvaccination in a double-blind, controlled study in which a substudy of 374 adults in the United States, 60 years of age and older (median age=66 years), were randomized to receive TIV and ZOSTAVAX concurrently (N=188), or TIV alone followed 4 weeks later by ZOSTAVAX alone (N=186).

A well-studied vaccine

• ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster in individuals 60 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia.
• ZOSTAVAX has been evaluated for safety in more than 20,000 adults.

Before administering ZOSTAVAX, please read the Prescribing Information and Patient Product Information.

Select Safety Information

ZOSTAVAX is contraindicated in persons with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; with a history of primary or acquired immunodeficiency states including leukemia; lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; or with AIDS or other clinical manifestations of infection with human immunodeficiency viruses. ZOSTAVAX is also contraindicated in persons on immunosuppressive therapy. ZOSTAVAX is not indicated in women of childbearing age and should not be administered to pregnant females.

Vaccine-related, injection-site and systemic adverse events in >1% of individuals in the Adverse Event Monitoring Substudy (AEMS), a subgroup of individuals from the Shingles Prevention Study (SPS) who received ZOSTAVAX (n=3,345), included headache (1.4%) and the following injection-site reactions: erythema (33.7%), pain/tenderness (33.4%), swelling (24.9%), hematoma (1.4%), pruritus (6.6%), and warmth (1.5%). Most of these adverse experiences were reported as mild in intensity.

From Day 0 to 42 postvaccination, in the overall study population, serious adverse experiences (SAEs) occurred at a similar rate (1.4%) in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS, the rate of SAEs was increased in the group who received ZOSTAVAX (1.9%) as compared to the placebo group (1.3%) from Day 0 to 42 postvaccination. Over the course of the entire study, in the overall study population, investigator-determined, vaccine-related serious adverse experiences were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).

Among reported serious adverse events in the SPS (Days 0–42 postvaccination), serious cardiovascular events occurred more frequently in subjects who received ZOSTAVAX (20 [0.6%]) than in subjects who received placebo (12 [0.4%]) in the AEMS. The frequencies of serious cardiovascular events were similar in subjects who received ZOSTAVAX (81 [0.4%]) and in subjects who received placebo (72 [0.4%]) in the entire SPS study cohort (Days 0–42 postvaccination).

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

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

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

Before administering ZOSTAVAX, please read the Prescribing Information and Patient Product Information.

ZOSTAVAX is a registered trademark of Merck & Co., Inc.