• RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks.
• 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.

Select safety information

• RotaTeq should not be administered to infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine.
• Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of RotaTeq should not receive further doses of RotaTeq.
• No safety or efficacy data are available for the administration of RotaTeq to infants who are potentially immunocompromised or to infants with a history of gastrointestinal disorders.
• Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts. RotaTeq is a solution of live reassortant rotaviruses and can potentially be transmitted to persons who have contact with the vaccine. The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus. Transmission was not evaluated in clinical trials.
• Over 71,000 infants were evaluated in 3 placebo-controlled clinical trials. Serious adverse events occurred in 2.4% of recipients of RotaTeq when compared to 2.6% of placebo recipients within the 42-day period of a dose of RotaTeq. Hematochezia reported as a serious adverse event for RotaTeq compared to placebo was <0.1% vs <0.1%. The most frequently reported serious adverse events for RotaTeq compared to placebo were bronchiolitis (0.6% vs 0.7%), gastroenteritis (0.2% vs 0.3%), pneumonia (0.2% vs 0.2%), fever (0.1% vs 0.1%), and urinary tract infection (0.1% vs 0.1%).
• In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6% vs 42.8%). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of RotaTeq as compared with placebo recipients were diarrhea (24.1% vs 21.3%), vomiting (15.2% vs 13.6%), otitis media (14.5% vs 13.0%), nasopharyngitis (6.9% vs 5.8%), and bronchospasm (1.1% vs 0.7%).
• 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, please read the Prescribing Information
and Patient Product Information.

RotaTeq is a registered trademark of Merck & Co., Inc.