Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 04 September 2018

Indication(s)

ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9). ROTARIX is approved for use in infants 6 weeks to 24 weeks of age. (1)

Full Prescribing information

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Advisory information

contraindications

• A demonstrated history of hypersensitivity to the vaccine or any component of the vaccine. (4.1, 11)
• History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. (4.2)
• History of intussusception. (4.3)
• History of Severe Combined Immunodeficiency Disease (SCID). (4.4, 6.2)

Special warnings and precautions

• The tip caps of the prefilled oral applicators of diluent contain natural rubber latex which may cause allergic reactions. (5.1)
• Administration of ROTARIX in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness of ROTARIX in infants with chronic gastrointestinal disorders have not been evaluated. (5.2)
• Safety and effectiveness of ROTARIX in infants with known primary or secondary immunodeficiencies have not been established. (5.3)
• In a postmarketing study, cases of intussusception were observed in temporal association within 31 days following the first dose of ROTARIX, with a clustering of cases in the first 7 days. (5.5, 6.2)

Adverse reactions
Common (≥5%) solicited adverse events included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. (6.1)

Usage information

Dosing and administration

FOR ORAL USE ONLY. (2.1)
• Each dose is 1 mL administered orally. (2.2)
• Administer first dose to infants beginning at 6 weeks of age. (2.2)
• Administer second dose after an interval of at least 4 weeks and prior to 24 weeks of age. (2.2)

More information

Category Value
Authorisation number BLA125265
Orphan designation No
Product NDC 58160-854
Date First Approved 13-01-2013
Marketing authorisation holder GlaxoSmithKline Biologicals