Drug Detail:Dengue vaccine live (monograph) (Dengvaxia)
Drug Class:
Usual Pediatric Dose for Infection Prophylaxis
6 to 16 years: 0.5 mL subcutaneously at months 0, 6, and 12 (3 doses total)
Comments:
- Not approved for use in individuals not previously infected by any dengue serotype or for whom information is unknown.
- Limitation of use: The safety and effectiveness of this vaccine have not been established in individuals living in dengue nonendemic areas who travel to dengue endemic areas.
Use: Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in patients with laboratory-confirmed previous dengue infection and living in endemic areas
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS:
- History of a severe allergic reaction to a previous dose of this vaccine or to any of the components
- Individuals with severe immunodeficiency or immunosuppression due to disease or therapy
Safety and efficacy have not been established in patients younger than 6 years or older than 65 years old.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- For subcutaneous use only
- Do not mix in the same syringe with other parenteral products
Storage requirements:
- After reconstitution, administer immediately or refrigerate at 2C to 8C (36F to 46F) and use within 30 minutes.
- Do not freeze.
- Protect from light.
- Do not use after expiration date
Reconstitution/preparation techniques:
- The manufacturer product information should be consulted.
General:
- Instruct vaccine recipients to report adverse reactions to their healthcare provider.
- Limitations of Use: This vaccine is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. Those not previously infected are at increased risk for severe dengue disease when vaccinated and subsequently infected with dengue virus.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
Frequently asked questions
- Why can't the dengue vaccine Dengvaxia be used in people who haven't already had dengue?