Zoster Vaccine Live

Trade Names:Zostavax- Injection, lyophilized 19,400 PFU of Oka/Merck varicella-zoster virus (live)

Pharmacology

Induces development of immune responses against varicella-zoster virus.

Indications and Usage

Prevention of herpes zoster (shingles) in individuals 60 yr of age and older.

Contraindications

History of primary or acquired immunodeficiency states (eg, leukemia, lymphomas of any type, malignant neoplasms affecting bone marrow or lymphatic system, AIDS or other clinical manifestations of infection with HIV); patients receiving immunosuppressive therapy; patients with active untreated tuberculosis; patients who are pregnant or may become pregnant; history of anaphylactic/anaphylactoid reaction to gelatin, neomycin (excluding contact dermatitis to neomycin), or any component of the vaccine.

Dosage and Administration

Subcutaneous Entire contents of single-dose vial.

General Advice

• For subcutaneous injection; do not inject IV.
• Administer as a single dose.
• Use only sterile syringes free of preservatives, antiseptics, and detergents.
• Reconstitute using only the supplied diluent, which is free of preservatives or other antiviral substances that might inactivate the vaccine virus.
• To prevent transfer of infectious diseases, use a separate sterile needle and syringe for reconstitution and administration.
• Store the vaccine frozen and reconstitute immediately upon removal from the freezer.
• Store the diluent at room temperature or in the refrigerator.
• To reconstitute the vaccine, withdraw the entire contents of the diluent vial into a syringe. The vaccine is a semi-hazy to translucent, off-white to pale yellow liquid when reconstituted.
• Visually inspect for particulate matter and discoloration prior to administration.
• Inject all of the diluent in the syringe into the vial of vaccine and mix thoroughly by gentle agitation.
• Withdraw entire contents into a syringe and inject the total volume of reconstituted vaccine subcutaneously, preferably into the upper arm.
• Administer the vaccine immediately after reconstitution to minimize loss of potency.
• Discard reconstituted vaccine if not used within 30 min.
• Do not freeze reconstituted vaccine.

Storage/Stability

Store frozen at an average temperature of 5°F or cooler until reconstitution. Protect from light. Store diluent at room temperature (68° to 77°F) or in the refrigerator (36° to 46°F).

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache, asthenia (1%).

Dermatologic

Skin disorder (1%).

EENT

Rhinitis (1%).

GI

Diarrhea (2%).

Local

Erythema (34%); pain/tenderness (33%); swelling (25%); pruritus (7%); warmth (2%); hematoma (1%).

Respiratory

Respiratory tract infection (2%); respiratory disorder (1%).

Miscellaneous

Fever, flu syndrome (2%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Acute illness

Defer vaccination in acute illness (eg, presence of fever higher than 101.3°F).

Immunosuppression

Zoster vaccine may result in more extensive vaccine-associated rash or disseminated disease in immunosuppressed individuals.

Patient Information

• Obtain patient history, including drug history and any known allergies.
• Question recipient about reactions to previous vaccines.
• Inform recipient of benefits and risks.
• Provide recipient with a copy of the patient information leaflet and discuss any questions or concerns.
• Inform recipient of the theoretical risk of transmitting the vaccine virus to varicella-susceptible individuals, including pregnant women who have not had chickenpox.
• Caution patient to avoid pregnancy for 3 mo after vaccination.
• Instruct recipient to report any adverse reactions to health care provider.

Copyright © 2009 Wolters Kluwer Health.