RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age.

Dosage and Administration For RotaTeq

The only rotavirus vaccine in a ready-to-use oral formulation

Fully liquid, ready to use, no reconstitution

The Only Rotavirus Vaccine in a Ready-to-Use Oral Formulation

  1. Specially designed tube for
    direct oral administration
  2. Ready-to-use liquid formulation
  3. Peel-off labels for record
    keeping
  4. Package has 2-D barcoding

RotaTeq is for oral use only. Not for injection.

Ease of Administration Video: RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)

RotaTeq: Ease of Administration

Use With Other Vaccines

In clinical trials, RotaTeq was routinely administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus vaccine, Haemophilus influenzae type b conjugate vaccine, hepatitis B vaccine, and pneumococcal conjugate vaccine. There was no evidence for reduced antibody responses to the vaccines that were concomitantly administered with RotaTeq.

3-dose vaccine series that aligns with routine well-baby visits.1,2

  • The 4- to 10-week interval between each dose can provide flexibility to complete the 3-dose series.
  • Based on the dosing schedule for RotaTeq, the 3-dose series can be completed as early as 14 weeks of age (eg, doses given at 6, 10, and 14 weeks of age).

Sample vaccination schedule for RotaTeq

The Dosing Schedule for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent): 3 Dose Vaccine Series Aligns With Well-Baby Visits at 2, 4, and 6 Months of Age
  1. aThe first dose of RotaTeq should be administered orally starting at 6 to 12 weeks of age, with subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.

The safety and efficacy of RotaTeq have not been established in infants less than 6 weeks of age or greater than 32 weeks of age.

ref1

Reference

  1. Centers for Disease Control and Prevention (CDC). Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States 2019. https://www.cdc.gov/vaccines/schedules/ downloads/child/0-18yrs-child-combined-schedule.pdf. Published February 22, 2019. Accessed October 22, 2019.
ref2

Reference

  1. Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices, Vaccines for Children program, Vaccines to prevent rotavirus gastroenteritis. https://www.cdc.gov/vaccines/programs/vfc/downloads/ resolutions/0608-rotavirus.pdf. Published June 25, 2008. Accessed October 22, 2019.

Indications and Usage for RotaTeq

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age.

The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.

RotaTeq, should not be administered to infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine.
Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent), should not be administered to infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine.

Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.

Infants with a history of intussusception should not receive RotaTeq.

No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised.

In a post-marketing observational study in the US, cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.

No safety or efficacy data are available for administration of RotaTeq to infants with a history of gastrointestinal disorders.

Vaccine virus transmission from vaccine recipient to nonvaccinated contacts has been reported. Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.

In clinical trials, the most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.

In post-marketing experience, intussusception (including death) and Kawasaki disease have been reported in infants who have received RotaTeq.

RotaTeq may not protect all vaccine recipients against rotavirus.

Before administering RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent), please read the Prescribing Information. The Patient Product Information also is available.

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age.

The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.


US-ROT-00187 03/20