Administration

ROTARIX vaccination:

  • LIQUID FORMULATION: Supplied in an oral dosing applicator only presentation. A single dose is 1.5 mL1
  • LYOPHILIZED FORMULATION: Supplied in a vial and an oral dosing applicator presentation. A single dose is 1 mL1

Watch a brief demonstration of ROTARIX here.

Instructions for Administration via Prefilled Oral Dosing Applicator1

The oral dosing applicator only presentation contains ROTARIX and does NOT require reconstitution or dilution before use.

Step 1: Remove the protective Tip Cap from the oral dosing applicator.

STEP 1: Remove the protective Tip Cap from the oral dosing applicator. Vaccine appears clear and colorless.

      

Step 2: For oral administration only. Have the infant seated in a reclining position. Place the oral dosing applicator towards the inner cheek. Administer the entire contents of the oral dosing applicator into the infant’s mouth.

STEP 2: For oral administration only. Have the infant seated in a reclining position. Place the oral dosing applicator towards the inner cheek. Administer the entire contents of the oral dosing applicator into the infant's mouth.

           

Do not use a needle with ROTARIX. Do not inject.

Do not use a needle with
ROTARIX. Do not inject.

      

Instructions for Administration via Vial and Oral Dosing Applicator1

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.

 

Use accompanying diluent to reconstitute the lyophilized vaccine component to form ROTARIX. After reconstitution, each dose of 1 mL is administered orally.

Step 1: Remove vial cap and push transfer adapter onto vial (lyophilized vaccine component).

STEP 1: Remove vial cap and push transfer adapter onto vial (lyophilized vaccine component).

           

Step 2: Shake diluent in oral dosing applicator. The diluent appears white and turbid. Connect oral dosing applicator to transfer adapter.

STEP 2: Shake diluent in oral dosing applicator. The diluent appears white and turbid. Connect oral dosing applicator to transfer adapter.

           

Step 3: Push plunger of oral dosing applicator to transfer diluent in vial. After reconstitution, vaccine will appear white and turbid.

STEP 3: Push plunger of oral dosing applicator to transfer diluent into vial. After reconstitution, vaccine will appear white and turbid.

           

Step 4: Withdraw vaccine into oral dosing applicator..

STEP 4: Withdraw vaccine into oral dosing applicator.

           

STEP 5: Twist to remove oral dosing applicator.

STEP 5: Twist to remove oral dosing applicator.

           

Step 6: For oral administration only. Have the infant seated in a reclining position. Place the oral dosing applicator towards the inner cheek. Administer the entire contents of the oral dosing applicator into the infant’s mouth.

STEP 6: For oral administration only. Have the infant seated in a reclining position. Place the oral dosing applicator towards the inner cheek. Administer the entire contents of the oral dosing applicator into the infant’s mouth.

           

Do not use a needle with ROTARIX. Do not inject.

Do not use a needle with
ROTARIX. Do not inject.

           

INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION FOR ROTARIX

INDICATIONS

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 dosing applicators 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.

References

  1. Prescribing Information for ROTARIX.