Condition on Arrival

• Must be frozen

Storage (Before reconstitution)

• During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of 5°F (–15°C) or colder.
• Before reconstitution, store the lyophilized vaccine continuously in a freezer (eg, chest, frost-free) for up to 18 months, at an average temperature of 5°F (–15°C) or colder. Any freezer that reliably maintains an average temperature of 5°F or colder and has a separate sealed freezer door is acceptable for storing ProQuad.
• ProQuad may be stored at refrigerator temperature (36°F to 46°F, 2°C to 8°C) for up to 72 hours prior to reconstitution. Vaccine stored at 36°F to 46°F which is not used within 72 hours of removal from 5°F storage should be discarded.
• For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.
• Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses.
• Diluent should be stored separately at room temperature (68°F to 77°F, 20°C to 25°C), or in a refrigerator (36°F to 46°F, 2°C to 8°C).

Handling

• Use only with diluent supplied, and administer immediately after reconstitution.
• DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.
• DO NOT FREEZE RECONSTITUTED VACCINE.

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 (68°F to 77°F,
  20°C to 25°C) or in the refrigerator (36°F to 46°F, 2°C to 8°C).
• 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.¹
• 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 to 7:00 pm ET.
• Before administering ProQuad, please read the Prescribing Information.
  

Select Safety Information

• ProQuad should not be administered to certain individuals, including those with any of the following: a history of anaphylactic reactions to neomycin; a history of hypersensitivity to gelatin or any other component of the vaccine; blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; an immunodeficient condition or receiving immunosuppressive therapy; active untreated tuberculosis; an active febrile illness (>101.3°F); or those who are pregnant.
• In clinical trials with ProQuad involving children 12 to 23 months of age, the most frequently reported injection-site adverse experiences (>1% of children) were pain/tenderness/soreness, erythema, swelling, ecchymosis, and rash. The most frequently reported systemic vaccine-related adverse experiences (>1% of children) were fever (>102°F), irritability, measles-like rash, varicella-like rash, rash (not otherwise specified), upper respiratory infection, viral exanthema, and diarrhea.
• In these trials, the only systemic vaccine-related adverse experiences that were reported at a significantly greater rate in individuals who received ProQuad than in individuals who received M-M-R^®_II and VARIVAX^® [Varicella Virus Vaccine Live (Oka/Merck)] were fever (>102°F [>38.9°C] oral equivalent or abnormal) (21.5% versus 14.9%, respectively), and measles-like rash (3.0% versus 2.1%, respectively).
• Febrile seizures have been reported in children receiving ProQuad. Consistent with clinical study data on the timing of fever and measles-like rash, an interim analysis of a postmarketing observational study in children (N = 14,263) receiving their first dose of vaccine has shown that febrile seizures occurred more frequently 5–12 days following vaccination with ProQuad (0.5 per 1000) when compared with data from children in a historical, age- and gender-matched, control group vaccinated with M-M-R^®_II and VARIVAX (N = 14,263) concomitantly (0.2 per 1000). In the 0–30 day time period following vaccination, the incidence of febrile seizures with ProQuad (1.0 per 1000) was not greater than that observed in children receiving M-M-R^®_II and VARIVAX concomitantly (1.3 per 1000).
• The duration of protection from measles, mumps, rubella, and varicella infections after vaccination with ProQuad is unknown.
• Vaccination with ProQuad may not offer 100% protection from measles, mumps, rubella, and varicella infection.
• Before administering ProQuad, please read the Prescribing Information.

Reference: 1. Centers for Disease Control and Prevention. Vaccine storage and handling (Appendix C). In Atkinson W, Hamborsky J, McIntyre L, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 10th ed. Washington DC: Public Health Foundation; 2007:C1–C20.

ProQuad, M-M-R^®_II, and VARIVAX are registered trademarks of Merck & Co., Inc.