DENGVAXIA(Dengue Tetravalent Vaccine, Live)Suspension for Subcutaneous Injection(三)
ard the vial if the solution iscloudy 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 andHandling (16.2).]
DENGVAXIA should not be mixed in the same syringe with other parenteral products.
2.3 Administration
After reconstitution, withdraw 0.5 mL of DENGVAXIA and administer subcutaneouslyimmediately or store refrigerated at 2C to 8C (36F to 46F) and use within 30 minutes. Do notadminister DENGVAXIA by intramuscular injection.
3 DOSAGE FORMS AND STRENGTHS
DENGVAXIA is a suspension for injection (supplied as a lyophilized powder to be reconstitutedwith the supplied diluent, 0.4% NaCl). A single dose, afterreconstitution, is 0.5 mL.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Do not administer DENGVAXIA to individuals with a history of severe allergic reaction to aprevious dose of DENGVAXIA or to any component of DENGVAXIA. [See Description (11).]
4.2 Immunocompromised Individuals
Do not administer DENGVAXIA to individuals with severe immunodeficiency orimmunosuppression due to disease or therapy.
5 WARNINGS AND PRECAUTIONS
5.1 Increased Risk of Severe Dengue Disease Following DENGVAXIA in
Persons not Previously Infected with Dengue VirusIn unvaccinated individuals, first dengue infections rarely cause severe dengue, while second
dengue infections with a different serotype are associated with an increased risk of severedengue. DENGVAXIA administration to individuals not previously infected by dengue virus isassociated with an increased risk of severe dengue disease when the vaccinated individual issubsequently infected with any dengue virus serotype. Therefore, healthcare professionals musteva luate individuals for prior dengue infection to avoid vaccinating individuals who have notbeen previously infected by dengue virus.
Previous infection by dengue virus can be eva luated through a medical record of previouslaboratory-confirmed dengue infection or through serotesting prior to vaccination.
There is no FDA cleared test available to determine a previous dengue infection. Availablenon-FDA cleared tests may yield false positive results (e.g., due to cross-reactivity with otherflaviviruses).
5.2 Management of Acute Allergic Reactions
DENGVAXIA may cause hypersensitivity reactions, including anaphylaxis. Appropriate medicaltreatment and supervision must be available following administration of DENGVAXIA.
5.3 Limitations of Vaccine Effectiveness
Vaccination with DENGVAXIA may not protect all individuals. It is recommended to continuepersonal protection measures against mosquito bites after vaccination.
5.4 Syncope
Syncope (fainting) can occur following, or even before, vaccination with DENGVAXIA as apsychogenic response to injection with a needle. Procedures should be in place to prevent injuryfrom falling and to manage syncopal reactions.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a vaccine cannot be directly compared to rates in the clinicaltrials of another vaccine and may not reflect the rates observed in practice.
The safety of DENGVAXIA in subjects 9 through 16 years of age was eva luated in 9randomized, placebo-controlled, multicenter c |
