May 24, 2017
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How Supplied


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 [see Clinical Studies]. ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.


Reconstitution Instructions For Oral Administration

For oral use only. Not for injection.

Reconstitute only with accompanying diluent. Do not mix ROTARIX with other vaccines or solutions.

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

Remove vial cap and push transfer adapter onto vial - Illustration

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

Oral applicator - Illustration

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

Push plunger of oral applicator - Illustration

Withdraw vaccine into oral applicator.

Withdraw vaccine into oral applicator - Illustration

Twist and remove the oral applicator.

Twist and remove the oral applicator - Illustration

Ready for oral administration.

Oral administration - Illustration

Do not use a needle with ROTARIX.

Not for injection.

Do not use a needle with ROTARIX - Illustration

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. There are no restrictions on the infant's liquid consumption, including breast-milk, either before or after vaccination with ROTARIX.


Dosage Forms And Strengths

ROTARIX 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 1060 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P[8] rotavirus after reconstitution.

Storage And Handling

ROTARIX is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution.

Supplied as an outer package of 10 doses (NDC 58160-854-52) containing:

NDC 58160-851-01 vial of lyophilized vaccine in package of 10: NDC 58160-851-10

NDC 58160-853-02 oral applicator of diluent (10 applicators)

Storage Before Reconstitution
  • Vials: Store the vials of lyophilized ROTARIX 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 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, US License 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/13/2017

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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