Version May 2024
(For additional information see "Dengue tetravalent live vaccine: Pediatric drug information")
Note: According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).
Dengue disease prevention (immunization): Note: Should only be used in individuals with laboratory-confirmed previous dengue disease and who are living in endemic areas; not for use in individuals traveling to endemic areas. Administration to individuals without previous infection increases the risk of severe dengue disease.
Children ≥6 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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children and adolescents.
>10%:
Local: Pain at injection site (19% to 32%)
Nervous system: Asthenia (13% to 25%), headache (19% to 34%), malaise (19% to 21%)
Neuromuscular & skeletal: Myalgia (15% to 29%)
1% to 10%:
Local: Erythema at injection site (1% to 6%), swelling at injection site (1% to 6%)
Miscellaneous: Fever (8% to 9%)
<1%:
Dermatologic: Erythema of skin, urticaria
Gastrointestinal: Abdominal pain, vomiting
Local: Hematoma at injection site, injection-site pruritus, local anesthesia (injection site), skin discoloration at injection site
Nervous system: Acute disseminated encephalomyelitis, dizziness, seizure, vertigo
Respiratory: Dyspnea, status asthmaticus
Postmarketing: Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Severe hypersensitivity to dengue tetravalent vaccine (live) or any component of the formulation; severe immunodeficiency or immunosuppression due to disease or therapy (including patients with symptomatic HIV infection or CD4 count <200 cells/mm3); lack of laboratory evidence of previous dengue infection (ACIP [Kroger 2023]; ACIP/CDC [Paz-Bailey 2021]).
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 2023]).
• 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 2023]).
Disease-related concerns:
• Acute Illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone vaccination in individuals with moderate or severe acute illness (with or without fever). The presence of a mild acute illness (with or without fever) should not delay vaccination (ACIP [Kroger 2023]).
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 nonlive) for which a person is eligible at a single visit, unless contraindications exist (ACIP [Kroger 2023]).
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.
• Pediatrics: Do not administer to persons <6 years of age; administration to these persons is associated with an increased risk of severe dengue disease and hospitalization when the vaccinated individual is subsequently infected with any dengue virus serotype, regardless of previous dengue virus infection.
• 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 (ACIP [Kroger 2023]).
Dengvaxia is only available in dengue disease endemic areas.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Subcutaneous [preservative free]:
Dengvaxia: (1 ea)
No
Parenteral: SUBQ: Use within 30 minutes following reconstitution; keep suspension refrigerated until use. Administer by SUBQ injection (typically into the anterolateral arm, over the triceps area); 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 (Ref).
Dengue disease, prevention: Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in patients 6 to 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.
Limitations of use: Not approved for individuals <6 years of age; these individuals, regardless of previous infection, are at increased risk of severe dengue disease and hospitalization following vaccination and subsequent infection with any dengue virus serotype. Not approved for use in 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. The safety and effectiveness of dengue tetravalent vaccine (live) have not been established in individuals living in dengue nonendemic areas who travel to dengue endemic areas.
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.
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
Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
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
Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). 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
Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
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
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
Outcome data related to the use of dengue tetravalent vaccine (live) in pregnancy are 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 patients 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 patients vaccinated during pregnancy in the Pregnancy Registry (800-822-2463); patients may also enroll themselves.
It is not known if the live virus from this vaccine is present in breast milk.
Potential vertical transmission of dengue virus through breast milk has been reported in infected patients. According to the manufacturer, the decision to breastfeed following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of vaccination to the mother.
Observe for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2023]). 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.
Duration: Efficacy of 77% to 81% was demonstrated over a period of 12 months.
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