Dengue disease (fever) prevention (immunization): Note: Should only be used in individuals with previous dengue disease (laboratory-confirmed) and living in endemic areas. Administration to individuals without previous infection increases the risk of severe dengue disease.
Children ≥9 years and Adolescents ≤16 years: SubQ: 0.5 mL/dose for 3 doses administered at 0, 6, and 12 months.
There are no dosing adjustments provided in the manufacturer's labeling.
There are no dosing adjustments provided in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Subcutaneous [preservative free]:
Dengvaxia: (1 ea)
No
Dengvaxia is only available in dengue disease endemic areas.
Parenteral: SubQ: Use within 30 minutes following reconstitution; keep suspension refrigerated until use. Administer by SubQ injection into the anterolateral arm; not for intradermal, IV, or IM administration. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, children and adolescents should be vaccinated while seated or lying down (ACIP [Kroger 2021]).
Store lyophilized vaccine antigen and diluent refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. After reconstitution, use immediately or store refrigerated for up to 30 minutes; discard if not used within 30 minutes of reconstitution.
Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in individuals with laboratory-confirmed previous dengue infection and living in endemic areas (FDA approved in ages 9 to 16 years).
Limitations of use: Not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. Safety and effectiveness of dengue tetravalent vaccine (live) have not been established in individuals living in dengue non-endemic areas who travel to dengue endemic areas.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Headache (30%), malaise (19% to 21%)
Local: Pain at injection site (23% to 32%)
Neuromuscular & skeletal: Myalgia (20% to 29%), asthenia (18% to 25%)
1% to 10%: Local: Swelling at injection site (2% to 4%)
<1%, postmarketing, and/or case reports: Abdominal pain, anaphylaxis, dyspnea, erythema of skin, hematoma at injection site, hypersensitivity reaction, injection site pruritus, local anesthesia (injection site), status asthmaticus, urticaria, vertigo, vomiting
Severe hypersensitivity to dengue tetravalent vaccine (live) or any component of the formulation; severe immunodeficiency or immunosuppression due to disease or therapy
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2021]).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2021]).
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Kroger 2021]).
Special populations:
• Adults: Not intended for use in patients >16 years of age.
• Altered immunocompetence: Use is contraindicated in severely immunocompromised patients (eg, patients receiving chemo-/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination or may have an adverse event secondary to replication.
• Persons not previously infected with dengue virus: Do not administer to persons not previously infected with dengue virus; administration to these persons is associated with an increased risk of severe dengue disease when the vaccinated individual is subsequently infected with any dengue virus serotype. Prior to vaccination, evaluate individuals for prior dengue infection (ie, documentation of previous laboratory-confirmed infection or perform serotesting).
Other warnings/precautions:
• Appropriate use: Only for use in patients with laboratory-confirmed previous dengue infection and living in endemic areas.
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2021]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Methotrexate: May enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Methotrexate may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Rabies Immune Globulin (Human): May diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. Risk D: Consider therapy modification
RiTUXimab: May enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. RiTUXimab may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Teplizumab: May enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification
Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Risk C: Monitor therapy
Information related to the use of dengue tetravalent vaccine (live) in pregnancy is limited (Skipetrova 2018). It is not known if the live virus from this vaccine can be transmitted from mother to fetus; however, vertical transmission of dengue virus has been reported in infected females with viremia at delivery
Maternal infection with dengue virus may increase the risk of adverse pregnancy outcomes.
Data collection to monitor pregnancy and infant outcomes following maternal immunization with dengue tetravalent vaccine (live) is ongoing. Healthcare providers are encouraged to enroll females vaccinated during pregnancy in the Pregnancy Registry (800-822-2463); females may also enroll themselves.
Observe for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2021]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Dengue tetravalent vaccine is a live vaccine that offers active immunization against dengue serotypes 1, 2, 3 and 4 in individuals previously infected with dengue fever.
Efficacy: In patients 9 to 16 years of age seropositive for dengue at baseline, the dengue tetravalent vaccine demonstrated 77% to 81% efficacy to any dengue virus serotypes after the third dose.
Duration: Efficacy of 77% to 81% was demonstrated over a period of 12 months.
