Dengvaxia Dosage

Dose

Three doses (0.5 mL each) 6 months apart (at month 0, 6, and 12).

Preparation

The package contains a vial of lyophilized vaccine antigen and a vial of saline diluent (0.4% NaCl).

After removing the "flip-off" caps, cleanse the lyophilized vaccine antigen and diluent vial stoppers with a suitable germicide. Do not remove the vial stoppers or metal seals holding them in place.

To reconstitute DENGVAXIA, use a sterile needle and syringe to withdraw 0.6 mL from the diluent vial and inject it into the vial of the lyophilized vaccine antigen. Swirl the vial gently.

Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.

Figure 1	Figure 2	Figure 3	Figure 4
Insert the syringe needle through the stopper of the vial of diluent and withdraw 0.6 mL liquid content.	Insert the syringe needle through the stopper of the vial of lyophilized vaccine antigen and inject the liquid into the vial.	Swirl vial gently. The syringe needle is not removed while swirling the vial.	After reconstitution, withdraw 0.5 mL. DENGVAXIA should be used immediately after reconstitution.

After reconstitution, the suspension is colorless and may develop trace amounts of white to translucent endogenous proteinaceous particles. [See Description (11).]

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy or contains particles other than trace amounts of white to translucent particles.

Discard reconstituted vaccine if not used within 30 minutes. [See How Supplied/Storage and Handling (16.2).]

DENGVAXIA should not be mixed in the same syringe with other parenteral products.

Administration

After reconstitution, withdraw 0.5 mL of DENGVAXIA and administer subcutaneously immediately or store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 30 minutes. Do not administer DENGVAXIA by intramuscular injection.