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).

Dosage and Administration

Recommended Dose and Schedule

  • Administer ZOSTAVAX as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm.

Preparation for Administration, Including Reconstitution

  • Use only sterile syringes free of preservatives, antiseptics, and detergents for each injection and/or reconstitution of ZOSTAVAX. Preservatives, antiseptics and detergents may inactivate the vaccine virus.
  • 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 the diluent in the syringe into the vial of the lyophilized vaccine and gently agitate to mix thoroughly.
  • Withdraw the entire contents of the 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.

Coadministration

  • Vaccinate your appropriate patients aged ≥50 years against herpes zoster and flu in a single visit: 1 visit, 2 vaccines.
  • ZOSTAVAX can be given concurrently with trivalent (TIV) or quadrivalent inactivated flu vaccines. In both studies, antibody responses were similar in both groups. See study designs below.a,b
    1. aStudy Design: In a double-blind, controlled substudy, 374 adults in the US, 60 years of age and older (median age=66 years), were randomized to receive trivalent inactivated influenza vaccine (TIV) and ZOSTAVAX concurrently (N=188), or TIV alone followed 4 weeks later by ZOSTAVAX alone (N=186). The antibody responses to both vaccines at 4 weeks postvaccination were similar in both groups.
    2. bStudy Design: In another double-blind, controlled study, 882 adults in the US, 50 years of age and older (median age=60 years), were randomized to receive quadrivalent inactivated influenza vaccine and ZOSTAVAX concurrently (N=440), or quadrivalent inactivated influenza vaccine alone followed 4 weeks later by ZOSTAVAX alone (N=442). The antibody responses to both vaccines at 4 weeks postvaccination were similar in both groups.
  • In a randomized clinical study, 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.
  • Limited safety and immunogenicity data from clinical trials are available on the concurrent administration of PNEUMOVAX 23 and vaccines other than ZOSTAVAX.

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