Adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic reaction occur.
No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to: 1. immunocompromised patients such as individuals with malignancies or who are otherwise immunocompromised; individuals receiving immunosuppressive therapy; 2. individuals infected with HIV; or 3. individuals who have received a blood transfusion or blood products, including immunoglobulins within 42 days.
No fecal shedding of vaccine strains was seen in a small subset of infants with serious medical conditions (e.g., cystic fibrosis, failure to thrive, cancer, congenital heart disease, and neutropenia) that were diagnosed after enrollment in the study. Health care providers may want to consider these data when assessing the benefits and potential risks of administering RotaTeq to infants with serious medical conditions while keeping in mind nearly all children are infected with naturally occurring rotavirus by age 5 years.
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 one vaccine recipient (0.3%) after dose 3. Transmission of vaccine virus strains to non-vaccinated contacts has been observed post-marketing. RotaTeq should be administered with caution to individuals with immunodeficient close contacts such as: 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 health care 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.
In worldwide post-marketing surveillance, cases of intussusception have been reported in temporal association with RotaTeq. (See Post-marketing Reports under Side Effects.)
Any acute infection or febrile illness may be 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 clinical studies were not designed to assess the level of protection provided by only 1 or 2 doses of RotaTeq. Post hoc analyses of data from a large clinical study suggest that RotaTeq provides protection against hospitalizations and emergency department visits for rotavirus gastroenteritis during administration of the 3-dose vaccination series starting from 14 days post dose 1.
No clinical data are available for RotaTeq when administered after exposure to rotavirus.
Post-marketing safety data from Australia have identified the likelihood of a small increased risk of intussusception shortly after the administration of the first dose of RotaTeq. No increased risk of intussusception was observed among infants receiving RotaTeq in two large post-marketing safety studies conducted in the United States. No increased risk of intussusception was observed in clinical trials following administration of RotaTeq compared with placebo. As a precaution, healthcare professionals should follow-up on any symptoms suggestive of intussusception (severe abdominal pain or distress, persistent vomiting, bloody stools, abdominal bloating and/or high fever). Parents/guardians should be advised to seek medical advice promptly where these signs/symptoms are evident.
Use in Children: RotaTeq has been shown to be generally well tolerated and highly efficacious in preventing rotavirus gastroenteritis when administered to infants 6 weeks through 32 weeks of age. (See Dosage & Administration for the recommended dosage schedule.)
Safety and efficacy have not been established in infants less than 6 weeks of age.