Zoster Vaccine, Live

Pronunciation: (ZOS-ter)
Class: Vaccines, viral

Trade Names

Zostavax
- Injection, lyophilized powder for suspension 19,400 plaque-forming units (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 persons 50 y of age and older.

Contraindications

Immunosuppression or immunodeficiency, including a history of primary or acquired immunodeficiency states (eg, leukemia, lymphoma or other malignant neoplasms affecting bone marrow or lymphatic system, AIDS or other clinical manifestations of infection with HIV); patients receiving immunosuppressive therapy; women who are pregnant or may become pregnant during or within 3 months of treatment; history of anaphylactic/anaphylactoid reaction to gelatin, neomycin (excluding contact dermatitis to neomycin), or any component of the vaccine.

Dosage and Administration

Adults 50 y of age and older

Subcutaneous 0.65 mL as a single dose.

General Advice

• For subcutaneous injection only; do not inject intravascularly or IM.
• Administer as a single dose in the deltoid region of the upper arm.
• Use only sterile syringes free of preservatives, antiseptics, and detergents for each injection.
• Store the vaccine frozen and reconstitute immediately upon removal from the freezer using the supplied diluent.
• Store the diluent separately at room temperature or in the refrigerator.
• To reconstitute the vaccine, withdraw the entire contents of the diluent vial into a syringe and mix thoroughly by gentle agitation.
• The vaccine is a semi-hazy to translucent, off-white to pale yellow liquid when reconstituted.
• Administer the vaccine immediately after reconstitution to minimize loss of potency.

Storage/Stability

Store vaccine 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).

Discard reconstituted vaccine if not used within 30 min. Do not freeze reconstituted vaccine.

Drug Interactions

Antineoplastic agents (eg, busulfan, carmustine, docetaxel, melphalan, mercaptopurine, paclitaxel, thiotepa)

The risk of live zoster vaccine–induced adverse reactions may be increased by coadministration of antineoplastic agents. Administration of live zoster vaccine to patients who are receiving antineoplastic agents should be deferred.

Antineoplastic monoclonal antibodies (eg, alemtuzumab)

The immune response to live zoster vaccine may be reduced. Avoid coadministration.

Immunosuppressive agents (eg, fingolimod, ustekinumab)

Zoster vaccine is a live vaccine and the risk of disseminated disease is greater in patients who are immunosuppressed. Coadministration is contraindicated.

Pneumococcal vaccine polyvalent

A reduced response to live zoster vaccine has been observed in individuals who received these vaccines concurrently compared with those who received these vaccines 4 wk apart. Administer the vaccines at least 4 wk apart.

Adverse Reactions

Cardiovascular

CHF (2%).

CNS

Headache (9%); asthenia (1%).

Dermatologic

Skin disorder (1%).

EENT

Rhinitis (1%).

GI

Diarrhea (2%).

Hypersensitivity

Hypersensitivity reactions, including anaphylactic reactions (postmarketing).

Local

Pain (54%); erythema (48%); swelling (40%); pain/tenderness (34%); pruritus (11%); warmth (4%); hematoma (2%); induration (1%).

Respiratory

Pulmonary edema, respiratory tract infection (2%); respiratory disorder (1%).

Miscellaneous

Fever, flu syndrome (2%); pain in extremity (1%).

Precautions

Pregnancy

Category Undetermined .

Lactation

Undetermined.

Children

Not indicated for prevention of primary varicella infection (chickenpox); do not use in children or adolescents.

Hypersensitivity

Serious adverse reactions, including anaphylaxis, have occurred.

Concurrent illness

Defer vaccination in acute illness (eg, presence of fever) or in persons with active untreated tuberculosis.

Immunosuppression

Zoster vaccine may result in disseminated disease in immunosuppressed or immunodeficient individuals.

Protection

Duration of protection beyond 4 y after vaccination is unknown.

Transmission of vaccine virus

May occur between vaccinees and susceptible contacts.

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 potential risk of transmitting the vaccine virus to susceptible individuals, such as immunosuppressed or immunodeficient individuals or 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.