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Dosing and Administration

Watch a brief demonstration of ROTARIX reconstitution and storage information here.

 

Complete the Rotavirus Vaccination Series in Just 2 Oral Doses1,2

DOSING SCHEDULE FOR ROTARIX1
Graph of dosing schedule for ROTARIX
  • Fewer doses. Only 2 doses to complete the series1-3
  • Flexible timing of administration. Can be used up to 24 hours after mixing1
  • 1-mL volume per dose1

Important Dosing Information1

  • Each 1-mL dose is administered orally with a prefilled applicator
  • Administer first dose 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
  • 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

ROTARIX is administered via an oral applicator1

Infant ready for oral administration

Ready for oral administration.

Do not use a needle with ROTARIX

Do not use a needle with ROTARIX. Not for injection.

 

Storage and Handling

ROTARIX package

Each package of ROTARIX contains1

  • 10 vials of lyophilized vaccine
  • 10 oral applicators prefilled with diluent
  • 10 transfer adapters

The tip caps of the prefilled oral applicators of diluent contain natural rubber latex, which may cause allergic reactions.1

Storage before reconstitution1

  • Lyophilized vaccine in vials: Store refrigerated at 2° to 8°C (36° to 46°F). Protect vials from light
  • Diluent in oral applicators: Store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Do not freeze. Discard if the diluent has been frozen

Storage after reconstitution1

  • ROTARIX should be administered within 24 hours of reconstitution
  • After reconstitution, store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Discard the reconstituted vaccine in biological waste container if not used within 24 hours
  • Do not freeze. Discard if the reconstituted vaccine has been frozen

References:

  1. Prescribing Information for ROTARIX.
  2. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2021. Centers for Disease Control and Prevention. Updated February 12, 2021. Accessed June 9, 2021. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
  3. Prescribing Information for RotaTeq.

Indications for ROTARIX

ROTARIX is a vaccine 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. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.

Important Safety Information for ROTARIX

  • Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine; uncorrected congenital malformation of the gastrointestinal tract (such as Meckel’s diverticulum) that would predispose the infant to intussusception; intussusception (in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose); or Severe Combined Immunodeficiency Disease (SCID)
  • The tip caps of the prefilled oral applicators of diluent contain natural rubber latex, which may cause allergic reactions
  • Administration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluated
  • Safety and effectiveness in infants with known primary or secondary immunodeficiencies, including infants with human immunodeficiency virus (HIV), infants on immunosuppressive therapy, or infants with malignant neoplasms affecting the bone marrow or lymphatic system have not been established
  • Rotavirus shedding in stool occurs after vaccination with peak excretion occurring around Day 7 after Dose 1. One clinical trial demonstrated that vaccinees transmit vaccine virus to healthy seronegative contacts. Caution is advised when considering whether to administer ROTARIX to individuals with immunodeficient close contacts
  • A study conducted after approval of ROTARIX showed an increased risk of intussusception in the 31 days after the first dose of ROTARIX, especially in the first 7 days. In other reports, an increased risk of intussusception has been observed within 7 days after dose 2
  • Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluated
  • In clinical studies, common (≥5%) solicited adverse reactions among recipients of ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting
  • Safety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated
  • The effectiveness of ROTARIX in pre-term infants has not been established
  • Vaccination with ROTARIX may not result in protection in all vaccine recipients
  • Please see full Prescribing Information for ROTARIX.