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No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to: Immunocompromised patients eg, individuals with malignancies or who are otherwise immunocompromised; individuals receiving immunosuppressive therapy; or individuals infected with HIV; or individuals who have received a blood transfusion or blood products, including immunoglobulins within 42 days.
In clinical trials, RotaTeq was not administered to infants known to have immunodeficient household members. In these trials, RotaTeq was shed in the stools of 8.9% of vaccine recipients almost exclusively in the week after dose 1 and in only 1 vaccine recipient (0.3%) after dose 3. There is a theoretical risk that the live virus vaccine can be transmitted to non-vaccinated contacts. Therefore, RotaTeq should be administered with caution to individuals with immunodeficient close contacts eg, individuals with malignancies or who are otherwise immunocompromised; or individuals receiving immunosuppressive therapy.
However, because nearly all children are infected with naturally occurring rotavirus by the age of 5 years, vaccination of infants may decrease the risk of exposure of immunodeficient household contacts to naturally occurring rotavirus. The healthcare provider should assess the potential risks and benefits of administering RotaTeq to infants known to have immunodeficient close contacts.
Infants with active gastrointestinal illness, chronic diarrhea or growth retardation, or a history of congenital abdominal disorders or intussusception were not to be included in the clinical studies. Administration of RotaTeq may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Any acute infection or febrile illness may be a reason for delaying use of RotaTeq except when, in the opinion of the physician, withholding the vaccine entails a greater risk. Low-grade fever itself and mild upper respiratory infection are not contraindications to vaccination with RotaTeq.
As with any vaccine, vaccination with RotaTeq may not result in complete protection in all recipients.
The level of protection provided by only 1 or 2 doses of RotaTeq was not studied in clinical trials.
No clinical data are available for RotaTeq when administered after exposure to rotavirus.
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Carcinogenicity, Mutagenicity & Impairment of Fertility: RotaTeq has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.
Use in pregnancy: RotaTeq is a pediatric vaccine and is not indicated for use in adults. There have been no adequate, well-controlled studies in women or animals.
Use in lactation: As RotaTeq is a pediatric vaccine and is not indicated for use in adults, information on the safety of RotaTeq vaccine when used during lactation is not available.
Use in children: RotaTeq has been shown to be generally well tolerated and highly efficacious in preventing rotavirus gastroenteritis when administered to infants 6-32 weeks of age. (For the recommended dosage schedule, see Dosage & Administration.)
Safety and efficacy have not been established in infants <6 weeks of age.
Use in the elderly: RotaTeq is not indicated for use in adult populations.
