ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children [see Clinical Studies].

Reconstitution Instructions for Oral Administration

For oral use only. Not for injection.

Reconstitute only with accompanying diluent. Do not mix ROTARIX (rotavirus vaccine, live, oral suspension) with other vaccines or solutions. Inspect vials visually for any cracks prior to administration. If any cracks exist, the vaccine should not be administered.

Remove vial cap and push transfer adapter onto vial (lyophilized vaccine).

Shake diluent in oral applicator (white, turbid suspension). Connect oral applicator to transfer adapter.

Push plunger of oral applicator to transfer diluent into vial. Suspension will appear white and turbid.

Withdraw vaccine into oral applicator.

Twist and remove the oral applicator.

Ready for oral administration.

Do not use a needle with ROTARIX (rotavirus vaccine, live, oral suspension) . Not for injection.

Recommended Dose and Schedule

The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose. The 2-dose series should be completed by 24 weeks of age.

Safety and effectiveness have not been evaluated if ROTARIX were administered for the first dose and another rotavirus vaccine were administered for the second dose or vice versa.

In the event that the infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be considered at the same vaccination visit.

Infant Feeding

Breast-feeding was permitted in clinical studies. There was no evidence to suggest that breast-feeding reduced the protection against rotavirus gastroenteritis afforded by ROTARIX (rotavirus vaccine, live, oral suspension) . There are no restrictions on the infant's liquid consumption, including breast-milk, either before or after vaccination with ROTARIX (rotavirus vaccine, live, oral suspension) .

Dosage Forms And Strengths

ROTARIX (rotavirus vaccine, live, oral suspension) is available as a vial of lyophilized vaccine to be reconstituted with a liquid diluent in a prefilled oral applicator.

Each 1-mL dose contains a suspension of at least 106.0 median Cell Culture Infective Dose (CCID₅₀) of live, attenuated human G1P[8] rotavirus after reconstitution.

Storage And Handling

ROTARIX (rotavirus vaccine, live, oral suspension) is available as a vial of lyophilized vaccine, a prefilled oral applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution.

Supplied as:

NDC 58160-805-11 (package of 10)

Storage Before Reconstitution

• Vials: Store the vials of lyophilized ROTARIX (rotavirus vaccine, live, oral suspension) refrigerated at 2° to 8°C (36° to 46°F). Protect vials from light.
• Diluent: The diluent may be stored at a controlled room temperature 20° to 25°C (68° to 77°F). Do not freeze. Discard if the diluent has been frozen.

Storage After Reconstitution

ROTARIX (rotavirus vaccine, live, oral suspension) should be administered within 24 hours of reconstitution. It may be stored refrigerated at 2° to 8°C (36° to 46°F) or at room temperature up to 25°C (77°F), after reconstitution. Discard the reconstituted vaccine if not used within 24 hours in biological waste container. Do not freeze. Discard if the vaccine has been frozen.

Manufactured by: GlaxoSmithKline Biologicals, Rixensart, Belgium. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. October 2008

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.