Rotarix_Liquid_DDA

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INDICATIONROTARIX 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 INFORMATIONContraindications 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 reactionsAdministration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluatedSafety 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 establishedRotavirus 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 contactsA 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 2Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluatedIn clinical studies, common (≥5%) solicited adverse reactions among recipients of ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomitingSafety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluatedThe effectiveness of ROTARIX in pre-term infants has not been establishedVaccination with ROTARIX may not result in protection in all vaccine recipientsPlease see full Prescribing Information for ROTARIX.

Dosing Schedule for ROTARIXThe vaccination series consists of two doses administered orally. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age. Each 1.5-mL dose is administered orally with a prefilled oral dosing applicatorAdminister first dose to infants beginning at 6 weeks of ageThere should be an interval of at least 4 weeks between the first and second doseThe 2-dose series should be completed by 24 weeks of ageSafety 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. INDICATIONROTARIX 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 INFORMATIONContraindications 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 reactionsAdministration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluatedSafety 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 establishedRotavirus 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 contactsA 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 2Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluatedIn clinical studies, common (≥5%) solicited adverse reactions among recipients of ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomitingSafety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluatedThe effectiveness of ROTARIX in pre-term infants has not been establishedVaccination with ROTARIX may not result in protection in all vaccine recipientsPlease see full Prescribing Information for ROTARIX.

Dosing Schedule for ROTARIXThe vaccination series consists of two doses administered orally. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age. Each 1.5-mL dose is administered orally with a prefilled oral dosing applicatorAdminister first dose to infants beginning at 6 weeks of ageThere should be an interval of at least 4 weeks between the first and second doseThe 2-dose series should be completed by 24 weeks of ageSafety 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. INDICATIONROTARIX 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 INFORMATIONContraindications 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 reactionsAdministration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluatedSafety 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 establishedRotavirus 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 contactsA 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 2Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluatedIn clinical studies, common (≥5%) solicited adverse reactions among recipients of ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomitingSafety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluatedThe effectiveness of ROTARIX in pre-term infants has not been establishedVaccination with ROTARIX may not result in protection in all vaccine recipientsPlease see full Prescribing Information for ROTARIX.