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Drug update
(dengue
vaccine)
DR MOHMMAD ISRAR
PG JR 1
GDMC DEHRADUN
 Qdenga powder and solvent for solution for
injection
 Qdenga powder and solvent for solution for
injection in pre-filled syringe Dengue
tetravalent vaccine (live, attenuated)
 Dengue tetravalent vaccine (live, attenuated)
 Qdenga is indicated for the prevention of dengue
disease in individuals from 4 years of age.
 Individuals from 4 years of age Qdenga should be
administered as a 0.5 mL dose at a two-dose (0 and 3
months) schedule. The need for a booster dose has
not been established.
After reconstitution, 1 dose (0.5 mL) contains:
 Dengue virus serotype 1 (live, attenuated)*: ≥ 3.3 log10
PFU**/dose
 Dengue virus serotype 2 (live, attenuated)#: ≥ 2.7 log10
PFU**/dose
 Dengue virus serotype 3 (live, attenuated)*: ≥ 4.0 log10
PFU**/dose
 Dengue virus serotype 4 (live, attenuated)*: ≥ 4.5 log10
PFU**/dose
Mechanism of action
 Mechanism of action Qdenga contains live
attenuated dengue viruses. The primary
mechanism of action of Qdenga is to replicate
locally and elicit humoral and cellular immune
responses against the four dengue virus
serotypes.
 Individuals from 4 years of age Qdenga should be
administered as a 0.5 mL dose at a two-dose (0 and 3
months) schedule.
 The need for a booster dose has not been
established.
Additional points
 18 months.
 Qdenga must be used within 2 hours.
 Store in a refrigerator (2°C to 8°C). Do not
freeze.
Contraindications
 Hypersensitivity
 Individuals with congenital or acquired immune deficiency,
including immunosuppressive therapies such as
chemotherapy or high doses of systemic corticosteroids (e.g.
20 mg/day or 2 mg/kg body weight/day of prednisone for 2
weeks or more) within 4 weeks prior to vaccination, as with
other live attenuated vaccines
 Pregnant
 Breast feeding
 In clinical studies, the most frequently reported
reactions in subjects 4 to 60 years of age were
injection site pain (50%), headache (35%), myalgia
(31%), injection site erythema (27%), malaise (24%),
asthenia (20%) and fever (11%).
Approved in Europe UK Brazil Argentina
Indonesia Thailand
Thank you

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Drug update (dengue vaccine).pptx

  • 1. Drug update (dengue vaccine) DR MOHMMAD ISRAR PG JR 1 GDMC DEHRADUN
  • 2.  Qdenga powder and solvent for solution for injection  Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)  Dengue tetravalent vaccine (live, attenuated)
  • 3.  Qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age.  Individuals from 4 years of age Qdenga should be administered as a 0.5 mL dose at a two-dose (0 and 3 months) schedule. The need for a booster dose has not been established.
  • 4. After reconstitution, 1 dose (0.5 mL) contains:  Dengue virus serotype 1 (live, attenuated)*: ≥ 3.3 log10 PFU**/dose  Dengue virus serotype 2 (live, attenuated)#: ≥ 2.7 log10 PFU**/dose  Dengue virus serotype 3 (live, attenuated)*: ≥ 4.0 log10 PFU**/dose  Dengue virus serotype 4 (live, attenuated)*: ≥ 4.5 log10 PFU**/dose
  • 5. Mechanism of action  Mechanism of action Qdenga contains live attenuated dengue viruses. The primary mechanism of action of Qdenga is to replicate locally and elicit humoral and cellular immune responses against the four dengue virus serotypes.
  • 6.
  • 7.
  • 8.  Individuals from 4 years of age Qdenga should be administered as a 0.5 mL dose at a two-dose (0 and 3 months) schedule.  The need for a booster dose has not been established.
  • 9. Additional points  18 months.  Qdenga must be used within 2 hours.  Store in a refrigerator (2°C to 8°C). Do not freeze.
  • 10. Contraindications  Hypersensitivity  Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g. 20 mg/day or 2 mg/kg body weight/day of prednisone for 2 weeks or more) within 4 weeks prior to vaccination, as with other live attenuated vaccines  Pregnant  Breast feeding
  • 11.  In clinical studies, the most frequently reported reactions in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%) and fever (11%).
  • 12. Approved in Europe UK Brazil Argentina Indonesia Thailand

Editor's Notes

  1. *Produced in Vero cells by recombinant DNA technology. Genes of serotype-specific surface proteins engineered into dengue type 2 backbone. This product contains genetically modified organisms (GMOs). #Produced in Vero cells by recombinant DNA technology **PFU = Plaque-forming units