irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.triamcinolone acetonide extended-release injectable suspensionMonitor Closely (1)triamcinolone acetonide extended-release injectable suspension decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.triamcinolone acetonide injectable suspensionMonitor Closely (1)triamcinolone acetonide injectable suspension decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.triptorelinMonitor Closely (1)triptorelin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.tuberculin purified protein derivativeSerious - Use Alternative (1)dengue vaccine decreases effects of tuberculin purified protein derivative by unspecified interaction mechanism. Avoid or Use Alternate Drug. Dengue vaccine may cause temporary depression of tuberculin purified protein derivative (PPD) test sensitivity, leading to false negative results. Perform PPD test before administering dengue vaccine or at least 1 month after vaccination.ublituximabMonitor Closely (1)ublituximab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.upadacitinibSerious - Use Alternative (1)upadacitinib decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.valrubicinMonitor Closely (1)valrubicin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.vandetanibMonitor Closely (1)vandetanib decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.varicella virus vaccine liveMonitor Closely (1)dengue vaccine, varicella virus vaccine live. unspecified interaction mechanism. Use Caution/Monitor. Data are not available to establish safety and immunogenicity of coadministration of dengue vaccine with recommended adolescent vaccines.vemurafenibMonitor Closely (1)vemurafenib decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.voclosporinSerious - Use Alternative (1)voclosporin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines. Avoid live vaccines for at least 3 months after immunosuppressants.vorinostatMonitor Closely (1)vorinostat decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine. 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 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 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 reportedPregnancy 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. 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 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 No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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