ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).

Storage and Handling

On Arrival

  • To maintain potency, ZOSTAVAX must be stored frozen between -58°F and +5°F (-50°C and -15°C). Use of dry ice may subject ZOSTAVAX to temperatures colder than -58°F (-50°C).
  • If you have questions about the vaccine’s condition on arrival, immediately place vaccine in recommended storage and call 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).
  • For further product information, call 1-800-MERCK-90.

Storage

  • Before reconstitution, ZOSTAVAX SHOULD BE STORED FROZEN at a temperature between -58°F and +5°F (-50°C and -15°C) until it is reconstituted for injection.
    • Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature between -58°F and +5°F (-50°C and -15°C) is acceptable for storing ZOSTAVAX. Routine defrost cycling of a frost-free freezer is acceptable.
  • ZOSTAVAX may be stored and/or transported at refrigerator temperature between 36°F and 46°F (2°C to 8°C) for up to 72 continuous hours prior to reconstitution.
    • Vaccine stored between 36°F and 46°F (2°C to 8°C) that is not used within 72 hours of removal from +5°F (-15°C) storage should be discarded.
    • ZOSTAVAX should be reconstituted immediately upon removal from the freezer. The diluent should be stored separately at room temperature (68°F to 77°F, 20°C to 25°C), or in the refrigerator (36°F to 46°F, 2°C to 8°C ).

Preparation for Administration, Including Reconstitution

  • ZOSTAVAX is stored frozen and should be reconstituted immediately upon removal from the freezer.
  • When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off-white to pale yellow liquid.
  • Use only the diluent supplied.
  • Withdraw the entire contents of the diluent into a syringe.
  • To avoid excessive foaming, slowly inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
  • Withdraw the entire contents of reconstituted vaccine into a syringe and inject the total volume subcutaneously, and discard vial.
  • ADMINISTER IMMEDIATELY AFTER RECONSTITUTION to minimize loss of potency. Discard reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.

Indication for ZOSTAVAX

ZOSTAVAX® (Zoster Vaccine Live) is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).

Vaccination with ZOSTAVAX® (Zoster Vaccine Live) does not result in protection of all vaccine recipients.
Do not administer ZOSTAVAX to individuals who are immunodeficient or immunosuppressed due to disease or therapy, as serious or fatal disseminated vaccine strain varicella-zoster virus disease may occur. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency states, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, and immunosuppressive therapy.

Vaccination with ZOSTAVAX® (Zoster Vaccine Live) does not result in protection of all vaccine recipients.

Do not administer ZOSTAVAX to individuals who are immunodeficient or immunosuppressed due to disease or therapy, as serious or fatal disseminated vaccine strain varicella-zoster virus disease may occur. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency states, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, and immunosuppressive therapy.

A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.

Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). Common adverse reactions occurring in ≥1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.

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

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

Before administering ZOSTAVAX, please read the accompanying Prescribing Information. The Patient Information also is available.

ZOSTAVAX® (Zoster Vaccine Live) is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).

US-CIN-00011 12/19