ZOSTAVAX Refrigerator Stable Formulation

Basic Information

Product Name

Dosage Form

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

Regulatory Information

Approval Number

SIN13564P

Approval Date

October 30, 2008

Forensic Classification

Prescription Only

Drug Type

Therapeutic

Route of Administration

SUBCUTANEOUS

Record Created

August 10, 2023

Last Updated

May 30, 2025

ATC Business ID

XJ07BK

Active Ingredients

LIVE ATTENUATED OKA/MERCK STRAIN OF VARICELLA-ZOSTER VIRUS

Strength: 19,400 pfu/dose

Detailed Information

Contraindications

**IV. CONTRAINDICATIONS** History of hypersensitivity to any component of the vaccine, including gelatin. History of anaphylactic/anaphylactoid reaction to neomycin (each dose of reconstituted vaccine contains trace quantities of neomycin). Neomycin allergy generally manifests as a contact dermatitis. However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines. ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration to individuals who are immunosuppressed or immunodeficient may result in disseminated varicella-zoster virus disease, including fatal outcomes. Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS (see **XIV. CLINICAL PHARMACOLOGY** and **XI. ADVERSE EVENTS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); cellular immune deficiencies. Immunosuppressive therapy (including high-dose corticosteroids) (see **XI. ADVERSE EVENTS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); however, ZOSTAVAX is not contraindicated for use in individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e.g., for adrenal insufficiency. Active untreated tuberculosis. Pregnancy (see **VI. PREGNANCY** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

Indication Information