Dosing and uses of Zostavax (zoster vaccine)
Adult dosage forms and strengths
injection solution
- 19,400 PFU/0.65 mL
Varicella-Zoster Virus Infection
0.65 mL (entire content of vial ) injected SC into upper arm as single dose
FDA approved as single dose for adults ≥50 years, regardless of whether they report prior episodes of herpes zoster; although vaccine is FDA-licensed for patients ≥50 years, Advisory Committee on Immunization Practices (ACIP) recommends that vaccination begin at 60 years; up-to-date vaccination schedules available at https://www.cdc.gov/vaccines/schedules/hcp/index.htmL
Administration
Reconstitute vaccine by using diluent supplied, first withdrawing all contents of diluent vial into syringe, then injecting solution into vial of lyophilized vaccine, and finally agitating to mix
Use separate needles and syringes for reconstituting and administration
Administer immediately after reconstitution
Inject total volume of reconstituted vaccine SC into upper arm
Discard if not used within 30 minutes
Pediatric dosage forms and strengths
Not indicated
Zostavax (zoster vaccine) adverse (side) effects
Suspected adverse events after administration of vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS) at 1-800-822-7967
>10%
Injection-site erythema
Pain or tenderness
Pruritus
Swelling
Warmth
1-10%
Diarrhea (2%)
Fever (2%)
Flulike syndrome (2%)
Upper respiratory tract infection (2%)
Headache (1%)
Rhinitis (1%)
Skin disorder (1%)
Weakness (1%)
<1%
Arthralgia
Hypersensitivity
Injection-site reactions
Postmarketing Report
Herpes zoster
Necrotizing retinitis (patients on immunosuppressive therapy)
Warnings
Contraindications
Hypersensitivity to gelatin, neomycin
Pregnancy
Not to be administered to immunosuppressed or immunodeficient individuals, including (1) those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma, or other malignant neoplasms affecting bone marrow or lymphatic system; (2) those with AIDS or other clinical manifestations of infection with HIV; (3) those receiving immunosuppressive therapy; (4) those with active tuberculosis
Cautions
Treatment provision (including epinephrine injection 1:1000) should be available for immediate use
Defer vaccination in patients with active untreated tuberculosis or acute illness
May not protect all vaccine recipients
Not to be given with 23-valent pneumococcal vaccine; concomitant use decreases immunogenicity of varicella-zoster virus (VZV) vaccine
Transmission of vaccine virus may occur between vaccinees and susceptible contacts (rare)
Not indicated for prevention of primary VZV infection (chickenpox)
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether agent is excreted in breast milk; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Zostavax (zoster vaccine)
Mechanism of action
Conveys active immunity by stimulating production of endogenously produced antibodies
