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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. |
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The first dose of RotaTeq should be administered between 6 and 12 weeks of age. |
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RotaTeq should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine. |
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No safety or efficacy data are available for the administration of RotaTeq to infants who are potentially immunocompromised, or with a history of gastrointestinal disorders. |
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Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts. |
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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%). |
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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%). |
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In post-marketing experience, cases of intussusception and Kawasaki disease have been reported in infants who have received RotaTeq. |
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RotaTeq may not protect all vaccine recipients against rotavirus. |
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Before administering RotaTeq, please read the Prescribing Information and Patient Product Information. |
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| Educate your patients about rotavirus and RotaTeq. |
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| RotaTeq is fully liquid, ready to use, and has peel-off labels for easy record keeping. |
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