HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DENGVAXIA safely and effectively. See full prescribing information for
DENGVAXIA.
DENGVAXIA(Dengue Tetravalent Vaccine, Live)Suspension for Subcutaneous Injection
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
DENGVAXIA is a vaccine indicated for the prevention of dengue diseasecaused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved foruse in individuals 9 through 16 years of age with laboratory-confirmedprevious dengue infection and living in endemic areas.
Limitations of use:
DENGVAXIA is not approved for use in individuals not previouslyinfected by any dengue virus serotype or for whom this information isunknown. Those not previously infected are at increased risk for severedengue disease when vaccinated and subsequently infected with denguevirus. (5.1)
Previous dengue infection can be assessed through a medicalrecord of a previous laboratory-confirmed dengue infection or throughserological testing prior to vaccination. (1)
The safety and effectiveness of DENGVAXIA have not been establishedin individuals living in dengue non-endemic areas who travel to dengueendemic areas. (1)
DOSAGE AND ADMINISTRATION
Three doses (0.5 mL each) 6 months apart (at month 0, 6, and 12). (2.1)

DOSAGE FORMS AND STRENGTHS
Suspension for injection (0.5 mL) supplied as a lyophilized powder to bereconstituted with the supplied diluent. (3)
CONTRAINDICATIONS
A history of severe allergic reaction to a previous dose of DENGVAXIAor to any component of DENGVAXIA. (4.1)
Immunocompromised individuals. (4.2)
WARNINGS AND PRECAUTIONS
In persons not previously infected by dengue virus, an increased risk ofsevere dengue disease can occur following vaccination withDENGVAXIA and subsequent infection with any dengue virus serotype.
There is no FDA-cleared test available to determine a previous dengueinfection. (5.1)
ADVERSE REACTIONS
The most frequently reported adverse reactions regardless of the dengueserostatus prior to vaccination were headache (40%), injection site pain (32%),malaise (25%), asthenia (25%) and myalgia (29%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact
Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive,Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at1-800-822-7967 or http://vaers.hhs.gov.
DRUG INTERACTIONS
False negative tuberculin purified protein derivative (PPD) test results mayoccur within 1 month following vaccination with DENGVAXIA. (7.3)
See 17 for PATIENT COUNSELING INFORMATION
Revised: [5/2019]
----------------------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose
2.2 Preparation
2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Immunocompromised Individuals
5 WARNINGS AND PRECAUTIONS
5.1 Increased Risk of Severe Dengue Disease FollowingDENGVAXIA in Persons not Previously Infected with Dengue
Virus
5.2 Management of Acute Allergic Reactions
5.3 Limitations of Vaccine Effectiveness
5.4 Syncope
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Data from Post-marketing Experience
7 DRUG INTERACTIONS
7.1 Concomitant Ad