Clinical Information
Gen. Code and Des.
65226 rotavirus vac,live att, 89-12 ORAL ORAL SUSP 10E6/1.5ML
GCN and Des.
24276 rotavirus vac,live att, 89-12 ORAL ORAL SUSP 10E6/1.5ML
Strength
Dose Form
SUSPENSION, ORAL (FINAL DOSE FORM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
11498 rotavirus vacc,live oral, 89-12 strain,g1p(8) type
Inactive Ingredients
11039 sodium bicarbonate 144558
2598 sucrose 57501
8921 latex
915 dextrose 5996101
9277 pork derived (porcine)
These highlights do not include all the information needed to use ROTARIX safely and effectively. See full prescribing information for ROTARIX.
ROTARIX (Rotavirus Vaccine, Live, Oral)
Suspension, for oral use
Initial U.S. Approval: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2, 2.3)
11/2022
INDICATIONS AND USAGE
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 and up to 24 weeks of age. (1)
DOSAGE AND ADMINISTRATION
FOR ORAL USE ONLY.
ROTARIX is supplied as either:
•
Vial and oral dosing applicator presentation: The vial contains the lyophilized vaccine component and the oral dosing applicator contains the diluent. The contents of the vial must be reconstituted with the diluent to form ROTARIX prior to administration (2.1), or
•
Oral dosing applicator only presentation: The oral dosing applicator contains ROTARIX and does NOT require reconstitution or dilution before use. (2.1)
Schedule
•
Administer first dose to infants beginning at 6 weeks of age. (2.3)
•
Administer second dose after an interval of at least 4 weeks and up to 24 weeks of age. (2.3)
DOSAGE FORMS AND STRENGTHS
Suspension for oral use.
•
Vial and oral dosing applicator presentation: a single dose is 1 mL. (3)
•
Oral dosing applicator only presentation: a single dose is 1.5 mL. (3)
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)
WARNINGS AND PRECAUTIONS
•
The tip caps of the prefilled oral dosing applicators 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 reactions included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2022
