Shingrix Dosage

​2.1 SHINGRIX Presentations

​SHINGRIX is supplied in two presentations, a vial and vial presentation and a prefilled syringe presentation.

​Vial and Vial Presentation

​The vial and vial presentation includes a vial of Lyophilized gE Antigen Component and a vial of Adjuvant Suspension Component. Reconstitute the Lyophilized gE Antigen Component with the Adjuvant Suspension Component to form SHINGRIX prior to administration.

Prefilled Syringe Presentation

​The prefilled syringe contains SHINGRIX and does not require reconstitution before use.

Preparation

Reconstitution Instructions for SHINGRIX Vial and Vial Presentation

​Reconstitute the Lyophilized gE Antigen Component (a sterile white powder) with the accompanying Adjuvant Suspension Component (an opalescent, colorless to pale brownish liquid) to form SHINGRIX. Use only the supplied Adjuvant Suspension Component for reconstitution. See Figures 1 through 4.

Figure 1. Cleanse both vial stoppers. Using a sterile needle appropriate for administering a vaccine intramuscularly and a sterile syringe, withdraw the entire contents of the vial containing the Adjuvant Suspension Component (liquid) by slightly tilting the vial. Vial 1 of 2.	Figure 2. Slowly transfer entire contents of syringe into the Lyophilized gE Antigen Component vial (powder). Vial 2 of 2.	Figure 3. Gently swirl the vial until powder is completely dissolved. Do not shake vigorously.	Figure 4. After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine and administer intramuscularly.

​After reconstitution, administer SHINGRIX immediately or store refrigerated between 2° and 8°C (36° and 46°F) and use within 6 hours. Discard reconstituted vaccine if not used within 6 hours.

​Instructions for SHINGRIX Prefilled Syringe Presentation

​Attach a sterile needle to the prefilled syringe and administer SHINGRIX intramuscularly.

Administration Instructions

For intramuscular use.

SHINGRIX is an opalescent, colorless to pale brownish liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Administer a single 0.5‑mL dose by intramuscular injection. The preferred site for intramuscular injection is the deltoid region of the upper arm.

Dose and Schedule

Administer two doses (0.5 mL each) intramuscularly according to the following schedules:

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A first dose at Month 0 followed by a second dose administered 2 to 6 months later.

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For individuals who are or will be immunodeficient or immunosuppressed and who would benefit from a shorter vaccination schedule: A first dose at Month 0 followed by a second dose administered 1 to 2 months later.