RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent): Celebrating 10 Years of FDA Approval 2006-2016
We are excited to announce that RotaTeq is celebrating 10 years of FDA approval.
Thank you for your efforts in vaccinating appropriate patients against rotavirus gastroenteritis over these past 10 years. We look forward to celebrating more milestones with you in the future.
RotaTeq is the only rotavirus vaccine with an indication that includes the G2 serotype. G2 has been shown to be the second most common cause of RGE in the United States overall after G1, although rotavirus serotype distribution varied by region and year. 1,a
aAccording to the most recently published data.
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.
Selected 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 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 ® (Rotavirus Vaccine, Live, Oral, Pentavalent) 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, please read the accompanying Prescribing Information. The Patient Product Information also is available. For additional copies of the Prescribing Information, please call 800-672-6372, visit RotaTeq.com, or contact your Merck representative.
Sherif Salib Associate Director, Global Marketing US Pediatric Franchise
Reference: 1. Hull JJ, Teel EN, Kerin TK, et al; for National Rotavirus Strain Surveillance System. United States rotavirus strain surveillance from 2005 to 2008: genotype prevalence before and after vaccine introduction. Pediatr Infect Dis J. 2011;30 (suppl 1):S42–S47.
Posted by Chris Dixon on 26th February, 2016 | Comments | Trackbacks
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