Storage and Handling

During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of -15°C (+5°F) or colder.

ZOSTAVAX SHOULD BE STORED FROZEN at an average temperature of -15°C (+5°F) or colder until it is reconstituted for injection. Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature of -15°C or colder is acceptable for storing ZOSTAVAX.

For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.

Before reconstitution, protect from light.

The diluent should be stored separately at room temperature (20 to 25°C, 68 to 77°F), or in the refrigerator (2 to 8°C, 36 to 46°F).

General Tips

• If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage; and call the Merck Vaccine Customer Center at 1-877-VAX-MERCK (1-877-829-6372), or call the CDC at 1-800-CDC-INFO (1-800-232-4636).
• When supplied, diluent should be stored separately at room temperature (2°C to -8°C, 36°F to 46°F) or in the refrigerator.
• Rotate stock so that the earliest-dated vaccine is used first.²
• Ensure that the freezer and/or refrigerator is plugged into an outlet in a protected area where they cannot be disconnected accidentally.²
• It is important to use a separate sterile syringe and needle for each
  individual patient to prevent transmission of infectious agents from one person to another.
• Needles should be disposed of properly and should not be recapped.³
• For vaccines that require reconstitution with diluent, use only the diluent supplied.
• For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Center at 1-800-MERCK-90 (1-800-637-2590), Monday through Friday, 8:00 am–7:00 pm ET.

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.