Zostavax� Shingles Vaccine Varicella - Zoster Virus Vaccine, Live, Attenuated, Preservative Free 19400 Unit / 0.65 mL Injection Single Dose Vial 0.65 mL
INDICATIONS AND USAGE
ZOSTAVAX� is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.
Limitations of Use of ZOSTAVAX:
ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia (PHN).
ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).
2 DOSAGE AND ADMINISTRATION
Subcutaneous administration only. Do not inject intravascularly or intramuscularly.
2.1 Recommended Dose and Schedule
Administer ZOSTAVAX as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm.
2.2 Preparation for Administration
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.
Reconstitution:
Use only the diluent supplied.
Withdraw the entire contents of the diluent into a syringe.
To avoid excessive foaming, slowly inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
Withdraw the entire contents of 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.
3 DOSAGE FORMS AND STRENGTHS
ZOSTAVAX is a lyophilized preparation of live, attenuated varicella-zoster virus (Oka/Merck) to be reconstituted with sterile diluent to give a single dose suspension with a minimum of 19,400 PFU (plaque forming units) when stored at room temperature for up to 30 minutes.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Do not administer ZOSTAVAX to individuals with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine. {1}
4.2 Immunosuppression
ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration may result in disseminated disease in individuals who are immunosuppressed or immunodeficient. Do not administer ZOSTAVAX to immunosuppressed or immunodeficient individuals including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
4.3 Pregnancy
Do not administer ZOSTAVAX to pregnant women. It is not known whether ZOSTAVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, naturally occurring varicella-zoster virus (VZV) infection is known to sometimes cause fetal harm. Therefore, ZOSTAVAX should not be administered to pregnant women, and pregnancy should be avoided for 3 months following administration of ZOSTAVAX.
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Serious adverse reactions, including anaphylaxis, have occurred with ZOSTAVAX. Adequate treatment provisions, including epinephrine injection (1:1,000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.
5.2 Transmission of Vaccine Virus
Transmission of vaccine virus may occur between vaccinees and susceptible contacts.
5.3 Concurrent Illness
Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
5.4 Limitations of Vaccine Effectiveness
Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.
The duration of protection beyond 4 years after vaccination with ZOSTAVAX is unknown. The need for revaccination has not been defined.
6 ADVERSE REACTIONS
The most frequent adverse reactions, reported in ≥1% of subjects vaccinated with ZOSTAVAX, were headache and injection-site reactions.
