Dengvaxia

— THERAPEUTIC DISORDERS TREATED —
  • Vaccines

Dengvaxia Generic Name & Formulations

General Description

Dengue tetravalent vaccine, live; susp for SC inj after reconstitution (contains 4.5–6.0 log10CCID50 of each chimeric yellow fever dengue (CYD) virus serotypes 1, 2, 3, 4); per 0.5mL; preservative-free.

How Supplied

Single-dose vial—1 (w. diluent)

Manufacturer

Generic Availability

NO

Dengvaxia Indications

Indications

Immunization against dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9–16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Limitations of Use

Not for use if not previously infected by any dengue virus serotype or for whom this information is unknown. Safety and efficacy have not been established in individuals living in dengue non-endemic areas who travel to dengue endemic areas.

Dengvaxia Dosage and Administration

Adult

>16yrs: not established.

Children

<9yrs: not established. Give by SC inj only. ≥9yrs to ≤16yrs: one 0.5mL dose at month 0, 6, and 12.

Dengvaxia Contraindications

Contraindications

Severe immunodeficiency or immunosuppression due to disease or therapy.

Dengvaxia Boxed Warnings

Not Applicable

Dengvaxia Warnings/Precautions

Warnings/Precautions

Increased risk of severe dengue infection following Dengvaxia if not previously infected by dengue virus. Evaluate for prior dengue infection; avoid vaccination if not previously infected or unknown. Have appropriate medical treatment and supervision available to manage allergic reactions. Limitations of vaccine effectiveness; advise to continue personal protection measures against mosquito bites after vaccination. Labor & delivery. Pregnancy. Nursing mothers.

Dengvaxia Pharmacokinetics

See Literature

Dengvaxia Interactions

Interactions

Immunosuppressants (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose steroids) may reduce immune response to Dengvaxia. May cause false (–) results of tuberculin purified protein derivative (PPD) test sensitivity; give tuberculin test before or ≥1month after Dengvaxia vaccine.

Dengvaxia Adverse Reactions

Adverse Reactions

Headache, inj site pain, malaise, asthenia, myalgia; hypersensitivity reactions, syncope.

Dengvaxia Clinical Trials

See Literature

Dengvaxia Note

Not Applicable

Dengvaxia Patient Counseling

See Literature

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