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Dengue Tetravalent Vaccine (Live)

Medically reviewed by Drugs.com. Last updated on Jul 16, 2020.

Pronunciation

(den GE te tre VA lent vak SEEN live)

Index Terms

  • Dengvaxia

Pharmacologic Category

  • Vaccine
  • Vaccine, Live (Viral)

Pharmacology

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 of Action

Efficacy of 77% to 81% was demonstrated over a period of 12 months.

Use: Labeled Indications

Dengue disease, prevention: Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in patients 9 to 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Limitations of use: 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.

Contraindications

Severe hypersensitivity to dengue tetravalent vaccine (live) or any component of the formulation; severe immunodeficiency or immunosuppression due to disease or therapy

Dosing: Pediatric

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.

Storage

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.

Drug Interactions

AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Brexucabtagene Autoleucel: May enhance the adverse/toxic effect of Vaccines (Live). Brexucabtagene Autoleucel may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone >2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines prior to therapy whenever possible. Exceptions: Deflazacort. Consider therapy modification

Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Deflazacort: May enhance the adverse/toxic effect of Vaccines (Live). Deflazacort may diminish the therapeutic effect of Vaccines (Live). Management: Administer all vaccines according to immunization guidelines prior to initiating deflazacort. Live vaccines should be administered at least 4 to 6 weeks prior to initiating deflazacort. Consider therapy modification

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. Monitor therapy

Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Guselkumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Consult full interaction monograph for dose interval recommendations. This interaction does not apply to oral Ty21a typhoid vaccine or others listed as exceptions. Consider therapy modification

Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Deflazacort; DexAMETHasone (Systemic); Fludrocortisone; Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination

Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification

Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Consider therapy modification

Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

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. Consider therapy modification

Risankizumab: May enhance the adverse/toxic effect of Vaccines (Live). 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). Avoid combination

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, do administer a scheduled PPD skin test for at least 4-6 weeks following administration of the vaccine. Simultaneous administration of a parenteral live vaccine and PPD skin test is acceptable. 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. Exceptions: Adenovirus (Types 4, 7) Vaccine; Cholera Vaccine; Rotavirus Vaccine. Monitor therapy

Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination

Adverse Reactions

>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

Warnings/Precautions

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 [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]).

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 [Ezeanolue 2020]).

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 [Ezeanolue 2020]).

Monitoring Parameters

Observe for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Considerations

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.

Patient Education

What is this drug used for?

• It is used to prevent dengue.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Muscle pain

• Headache

• Loss of strength and weakness

• Injection site pain, redness, or swelling

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Dizziness

• Passing out

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Related questions

More about dengue vaccine

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Other brands: Dengvaxia