Dengvaxia

Dengvaxia

Manufacturer:

sanofi pasteur

Distributor:

DKSH
Concise Prescribing Info
Contents
Dengue tetravalent vaccine (live, attenuated) (4.5-6 log10 CCID50 of each CYD dengue virus serotypes 1, 2, 3 & 4)
Indications/Uses
Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 & 4 in individuals 12-45 yr w/ test-confirmed previous dengue infection.
Dosage/Direction for Use
SC Primary vaccination 3 inj of 0.5 mL at 6-mth interval.
Contraindications
Hypersensitivity or history of severe allergic reaction (including to those w/ other similar-component vaccines). Postpone vaccination in individuals suffering from moderate to severe febrile or acute disease. Congenital or acquired immune deficiency that impairs cell-mediated immunity, including immunosuppressive therapies (eg, chemotherapy or high doses of systemic corticosteroids generally given for ≥2 wk). Symptomatic or asymptomatic HIV infection when accompanied by evidence of impaired immune function. Pregnancy & lactation.
Special Precautions
Not for intravascular inj. May not protect all vaccinees; continue personal protection measures against mosquito bites after vaccination. Follow-up & appropriately manage any vaccines w/ signs & symptoms of dengue fever w/ particular attention to dengue warning signs (eg, high fever, severe abdominal pain or tenderness, persistent vomiting, mucosal bleeding, somnolence & hyperactivity). Not to be used on individuals not previously infected by the dengue virus; increased risk of hospitalization for dengue & clinically severe dengue in individuals not previously infected by dengue virus. Confirm previous infection by a test before vaccination in the absence of documented prior dengue virus infection. Limit testing prior to vaccination to individuals who have been in potential contact w/ dengue virus (eg, individuals who lived before or had recurrent stay in endemic areas) & who are likely to be exposed to dengue in the future. Wait until immune function has recovered in patients receiving high doses of systemic corticosteroids given for ≥2 wk. Not recommended for individuals living in non-endemic areas, who have not been in potential contact w/ dengue virus & who only occasionally travel to endemic areas. Individuals w/ a history of serious or severe reactions w/in 48 hr after a prior administration. Syncope may occur following or before any vaccination; place procedures to prevent injury from falling & to manage syncopal reactions. Women of childbearing age should avoid becoming pregnant for 4 wk after vaccination. Not to be administered in childn <12 yr.
Adverse Reactions
Headache; myalgia; inj site pain, malaise, asthenia, fever. Inj site reactions (erythema, hematoma, swelling, pruritus).
Drug Interactions
Not to be mixed w/ any other injectable vaccines or medications. Advise patients receiving Ig or blood products containing Ig (eg, blood or plasma) to wait for at least 6 wk preferably 3 mth following the end of treatment prior to vaccination.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BX - Other viral vaccines ; Used for active immunizations.
Presentation/Packing
Form
Dengvaxia powd for inj
Packing/Price
(+ 0.5 mL solvent pre-filled syringe) 1 dose x 1's
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