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VACCINE PATIENT ASSISTANCE

CODING FOR GSK VACCINES

 

Dosing and Administration

Complete the Rotavirus Vaccination Series in Just 2 Oral Doses1,3

DOSING SCHEDULE FOR ROTARIX1
  • Fewer doses. Only 2 doses to complete the series1,3,4
  • Flexible timing of administration. Can be used up to 24 hours after mixing1,4
  • 1mL volume per dose with diluent stored at room temperature (diluent may be stored in refrigerator or at room temperature)1,4

Important Dosing Information

  • Each 1-mL dose is administered orally with a prefilled applicator1
  • Administer first dose to infants beginning at 6 weeks of age1
  • There should be an interval of at least 4 weeks between the first and second dose1
  • The 2-dose series should be completed by 24 weeks of age1

ROTARIX is administered orally with the ease of an oral applicator, offering precise delivery1

sized
sized

Ready for oral administration.

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

Storage and Handling1

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.

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. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007;370:1757-1763.
  3. Centers for Disease Control and Prevention. Recommended Immunization Schedules for Persons Aged 0 Through 18 Years—United States, 2016. http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed November 26, 2019.

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%) 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

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