dengue vaccine (Rx)

Brand and Other Names:Dengvaxia
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Dosing & Uses

AdultPediatric

See Pediatric Dosing

Dosage Forms & Strengths

injectable, lyophilized vaccine antigen for reconstitution

  • 4.5-6 log10 CCID-50 per vial
  • CCID-50 = 50% cell culture infectious dose

Dengue Disease Prevention

Vaccine indicated for prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 for individuals aged 9-16 yr with laboratory-confirmed previous dengue infection and living in endemic areas

3-dose series; aged 9-16 years: 0.5 mL SC x 3 doses administered 6 months apart

Dosing Considerations

Limitations of use

  • Not approved for 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
  • Previous dengue infection can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing prior to vaccination
  • Safety and effectiveness have not been established in individuals living in dengue nonendemic areas who travel to dengue endemic areas
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Interactions

Interaction Checker

and dengue vaccine

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    Contraindicated

      Serious - Use Alternative

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            Adverse Effects

            Adverse reactions within 7 days

            Reaction in children and adolescents aged 9-16 yr

            Any grade

            • Headache (29.6-39.9%)
            • Pain (22.5-32.4%)
            • Myalgia (20-29.2%)
            • Asthenia (16.3-24.6%)
            • Malaise (19.3-24.5%)
            • Fever (5.9-7.3%)
            • Swelling (1.6-3.5%)
            • Erythema (1.5-4.1%)

            Grade 3

            • Headache (2.1-5.1%)
            • Asthenia (1.3-2.7%)
            • Malaise (1.3-2.4%)
            • Myalgia (1.5-2.2%)
            • Fever (0.8-1.7%)
            • Pain (0.8-0.9%)
            • Erythema (<0.1%)

            Severe Dengue Infection

            From month 13 to month 60-72 in children and adolescents aged 9-16 yr

            Previous dengue infection (seropositive at month 13): 0.068% (HR 0.18)

            No previous dengue infection (seronegative at month 13): 0.38% (HR 6.25)

            Postmarketing Reports

            Immune system disorders: Allergic, including anaphylactic reactions

            Infections and infestations: Severe dengue infection, including hospitalization and death, in individuals for whom dengue infection status prior to vaccination was unknown and who were subsequently infected with dengue following vaccination

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            Warnings

            Contraindications

            Hypersensitivity

            Individuals with severe immunodeficiency or immunosuppression due to disease or therapy

            Cautions

            May cause hypersensitivity reactions, including anaphylaxis; appropriate medical treatment and supervision must be available following administration

            Vaccination may not protect all individuals; continue personal protection measures against mosquito bites after vaccination

            Syncope can occur following or before vaccination as a psychogenic response to injection with a needle; prevent injury from falling and manage syncopal reactions

            Uninfected individuals

            • Evaluate individuals for prior dengue infection to avoid vaccinating individuals who have not been previously infected by dengue virus
            • In unvaccinated individuals, first dengue infections rarely cause severe dengue, while second dengue infections with a different serotype are associated with an increased risk of severe dengue
            • Administration to individuals not previously infected by dengue virus is associated with increased risk of severe dengue disease when the vaccinated individual is subsequently infected with any dengue virus serotype
            • There is no FDA-cleared test available to determine previous dengue infection; available non-FDA-cleared tests may yield false-positive results owing to cross-reactivity with other flaviviruses

            Drug interaction overview

            • Data unavailable to establish safety and immunogenicity of coadministration with recommended adolescent vaccines
            • Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (greater than physiologic doses), may reduce the immune response to dengue vaccine
            • Dengue vaccine may cause temporary depression of tuberculin purified-protein derivative (PPD) test sensitivity, leading to false-negative results; perform tuberculin testing before immunization or at least 1 month following
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            Pregnancy

            Pregnancy

            Available data in pregnant women are not sufficient to determine the effects of dengue vaccine on pregnancy, embryo-fetal development, parturition, and postnatal development

            Pregnancy exposure registry: 1-800-VACCINE (1-800-822-2463)

            Limited number of inadvertent exposures during pregnancy reported during clinical studies; isolated adverse pregnancy outcomes (eg, stillbirth, intrauterine death, spontaneous abortion, blighted ovum) observed for these exposed pregnancies, with similar frequency and nature in the vaccinated individuals compared with control group, and with risk factors identified for all cases

            Clinical considerations

            • Pregnant women are at increased risk of complications associated with dengue infection compared with nonpregnant women
            • Pregnant women with dengue may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery
            • Vertical transmission of dengue virus from mothers with viremia at delivery to their infants reported

            Fetal/neonatal adverse effects

            • Vaccine viremia can occur 7-14 days after vaccination with a duration of <7 days
            • Potential for transmitting the vaccine virus from mother to infant is unknown

            Lactation

            Human data are not available to assess dengue vaccine impact on milk production, its presence in breast milk, or its effects on the breastfed child

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the vaccine and any potential adverse effects on the breastfed child from dengue vaccine or from the underlying maternal condition

            Vertical transmission of dengue virus, including potentially through breastmilk, has been reported

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Elicits dengue-specific immune responses against the 4 dengue virus serotypes (ie, serotypes 1, 2, 3, and 4)

            Exact mechanism of protection has not been determined

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            Administration

            SC Preparation

            Package contains vial of lyophilized vaccine antigen and vial of 0.4% NaCl diluent

            Withdraw 0.6 mL from the diluent vial and inject into the lyophilized vaccine antigen vial

            Without removing needle, swirl vial gently

            Once reconstituted, suspension should appear colorless and may develop trace amounts of white-to-translucent endogenous proteinaceous particles

            Discard vial if the solution is cloudy or contains particles other than trace amounts of white-to-translucent particles

            After reconstitution, withdraw 0.5 mL, and then change needle before administering

            Discard reconstituted vaccine if not used within 30 minutes

            Do not mix in the same syringe with other parenteral products

            SC Administration

            For SC administration only; do not administer IM

            Storage

            Lyophilized vaccine antigen: Refrigerate at 2-8°C (36-46°F); do not freeze; protect from light

            Reconstituted vial: If not immediately administered, may refrigerate at 2-8°C (36-46°F) for up to 30 minutes

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            Formulary

            FormularyPatient Discounts

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            Tier Description
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.