Condition on Arrival

• Should be frozen
• Click here to see an image of the shipping carton.

Storage

• Before reconstitution, store the lyophilized vaccine in a freezer at an average temperature of –15°C (+5°F) or colder.
• Any freezer (eg, chest, frost-free) that reliably maintains an average temperature of –15°C and has a separate sealed freezer door is acceptable for storing the vaccine; dormitory style freezers are not acceptable for the storage of varicella vaccine.
• May be stored at refrigerator temperature (2°C to 8°C, 36°F to 46°F) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 2°C to 8°C (36°F to 46°F) that is not used within 72 hours of removal from –15°C storage should be discarded.
• Before reconstitution, protect from light.
• The diluent should be stored separately at room temperature (20°C to 25°C, 68°F to 77°F), or in the refrigerator.

Handling

• To reconstitute, use only diluent supplied, since it is free of preservatives or other antiviral substances that might inactivate the vaccine virus.
• To reconstitute vaccine, first withdraw 0.7 mL of diluent into the syringe to be used for reconstitution; inject all the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of the upper arm (deltoid) or the anterolateral thigh.
• IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION TO MINIMIZE LOSS OF POTENCY; DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.
• DO NOT FREEZE reconstituted vaccine.
• Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine when reconstituted is a clear, colorless to pale yellow liquid.

General Tips

• If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage; and call the Merck Vaccine Customer Center at 1-877-VAX-MERCK (1-877-829-6372), or call the CDC at 1-800-CDC-INFO (1-800-232-4636).
• When supplied, diluent should be stored separately at room temperature (20°C to 25°C,
  68°F to 77°F) or in the refrigerator.
• Rotate stock so that the earliest-dated vaccine is used first.¹
• Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.¹
• It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis and other infectious agents from one person to another.
• Needles should be disposed of properly and should not be recapped.²
• All vaccines must be discarded after the expiration date; expired or damaged Vaccines for Children (VFC) vaccines must be returned to your State Immunization Program.
• For vaccines that require reconstitution with diluent, use only the diluent supplied. Click here for a demonstration of reconstitution with diluent.
• For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Center at 1-800-MERCK-90 (1-800-637-2590), Monday through Friday, 8:00 am–7:00 pm ET.
• Before administering VARIVAX, please read the Prescribing Information

VARIVAX is indicated for vaccination against varicella in individuals 12 months of age and older.

Children 12 months to 12 years of age should receive a 0.5-mL dose administered subcutaneously; if a second 0.5-mL dose is administered to children, it should be given a minimum of 3 months later.

Adolescents and adults 13 years of age and older should receive a 0.5-mL dose administered subcutaneously at elected date and a second 0.5-mL dose 4 to 8 weeks later.

Select Safety Information

VARIVAX is contraindicated in certain individuals, including those with: a history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactoid reaction to neomycin; blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; an immunodeficient condition or receiving immunosuppressive therapy; active, untreated tuberculosis; active febrile illness; or those who are pregnant.

In children, adolescents, and adults monitored for up to 42 days, the adverse effects most frequently reported were as follows: fever, injection-site complaints, varicella-like rash (injection site), and
varicella-like rash (generalized).

In a clinical trial involving children who received 2 doses of VARIVAX 3 months apart, the incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was slightly higher post-dose 2 (overall incidence 25.4%) than post-dose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower post-dose 2 (66.3%) than post-dose 1 (85.8%).

The duration of protection of VARIVAX is unknown; however, long-term efficacy studies have demonstrated continued protection up to 10 years after vaccination.

Vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents,
and adults.

Before administering VARIVAX, please read the accompanying Prescribing Information.

Reference: 1. Centers for Disease Control and Prevention. Vaccine management: Recommendations for storage and handling selected biologicals. In: Atkinson W, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 9th ed. Atlanta, Ga: Dept of Health and Human Services; 2006: Appendix C. 2. Centers for Disease Control and Prevention. National Immunization Program. Vaccine storage and handling. http://www2a.cdc.gov/nip/isd/shtoolkit/splash.html. Accessed November 9, 2006.

VARIVAX is a registered trademark of Merck & Co., Inc.