About ZOSTAVAX

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).

Select Safety Information for ZOSTAVAX® (Zoster Vaccine Live)

Vaccination with ZOSTAVAX 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® (Zoster Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available.

1. Insinga RP, Itzler RF, Pellissier JM, et al. The incidence of herpes zoster in a United States administrative database J Gen Intern Med. 2005;20(8):748–753.
2. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0015.
3. Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1–30.
4. Johnson RW, Bouhassira D, Kassianos G, et al. The impact of herpes zoster and post-herpetic neuralgia on quality-of-life. BMC Med. 2010;8(37). doi:10.1186/1741-7015-8-37.
5. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1203696-0003.
6. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0002.
7. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0016.
8. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1114216-0004.

Dosage and Administration

  • Recommended Dose and Schedule
    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
    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.
    • ADMINISTER IMMEDIATELY AFTER RECONSTITUTION to minimize loss of potency. Discard reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.
    Learn more about storage and handling for ZOSTAVAX
  • Coadministration
    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

      Study 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.

      Study 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.

About ZOSTAVAX

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).

Select Safety Information for ZOSTAVAX® (Zoster Vaccine Live)

Vaccination with ZOSTAVAX 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® (Zoster Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available.

VACC-1133787-0020 05/18
Indication

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).

Select Safety Information

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

ZOSTAVAX is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.

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® (Zoster Vaccine Live), please read the Prescribing Information. The Patient Information is also available.

x
Indication

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).

Select Safety Information

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

ZOSTAVAX is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.

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® (Zoster Vaccine Live), please read the Prescribing Information. The Patient Information is also available.

x