RotaTeq:
multiple serotypes…a
pentavalent vaccine
RotaTeq is a live, oral, pentavalent
vaccine that contains 5 live reassortant rotaviruses. It
is designed to include most
of the common rotavirus serotypes circulating in the United
States.
RotaTeq is indicated for the prevention of rotavirus
gastroenteritis (RGE) 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 first
dose of RotaTeq
should be administered between 6 and 12 weeks of age, with
subsequent doses administered at 4- to 10-week intervals. The
third dose should not be given after 32 weeks of age.
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.
High-level
efficacy
RotaTeq demonstrated substantial efficacy against
RGE caused by serotypes G1, G2, G3, and G4.3
> Learn
more about the efficacy of RotaTeq
Detailed safety profile
RotaTeq
was studied in the Rotavirus Efficacy & Safety
Trial (REST), one of the largest vaccine trials in history,
evaluating nearly 70,000 infants.3,4
> Learn more about
the safety profile of RotaTeq
Convenient
dosage and administration
No vials, no needles, no reconstitution.
The dosing schedule for RotaTeq aligns with well-baby visits
at 2, 4, and 6 months of age.
> Learn more about the dosing and ease of administration of RotaTeq
Established in your practice
Over 12 million doses have been distributed to health care
providers across the country since approval by the Food and
Drug Administration (FDA) in February 2006.5
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.
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.
In clinical trials, the most common adverse events
included diarrhea, vomiting, irritability, otitis media,
nasopharyngitis, and bronchospasm.
In post-marketing experience,
cases of intussusception 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.
|
