Helping to Protect Your Baby From Rotavirus

About RotaTeq

 
 

In a large clinical trial, RotaTeq demonstrated 98% efficacy against severe rotavirus gastroenteritis (RGE) and 74% efficacy against RGE of any severity through the first rotavirus season after vaccination. Also, infants who were vaccinated with RotaTeq were 94% less likely to visit an emergency room and 96% less likely to be hospitalized through the first 2 years after the third dose, due to the types of rotavirus targeted by the vaccine.

When Should Your Baby Be Vaccinated?

How Is RotaTeq Given?

  • RotaTeq is not a shot; the vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later, and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.
RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) Is Given to Babies by Mouth

Nearly all children are infected by rotavirus by age 5. In the past, rotavirus had been responsible for more than 200,000 emergency room visits and 55,000 to 70,000 hospitalizations in the US each year.

RotaTeq is a vaccine that can help protect babies against common types of rotavirus. Rotavirus is a leading cause of severe diarrhea in infants.

IMPORTANT SAFETY INFORMATION

  • RotaTeq may not fully protect all children who get the vaccine.
  • RotaTeq should not be given to infants who are allergic to any part of the vaccine.
  • Your child should not get RotaTeq if he or she has Severe Combined Immunodeficiency Disease (SCID).
  • Your child should not get RotaTeq if he or she has ever had intussusception, a form of blockage in the intestines.
  • The most common side effects reported after taking RotaTeq were diarrhea, vomiting, fever, runny nose and sore throat, wheezing or coughing, and ear infection.
Read more Important Safety Information below

IMPORTANT SAFETY INFORMATION (continued)

Other reported side effects include: hives; Kawasaki disease (a serious condition that can affect the heart, symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet, and if untreated, can be life threatening).

Call your child’s doctor or go to the emergency department right away if your child has any of the following problems after getting RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent), even if it has been several weeks since the last dose, because these may be signs of a serious problem called intussusception:

  • bad vomiting
  • bad diarrhea
  • severe stomach pain
  • blood in the stool.

Intussusception happens when a part of the intestine gets blocked or twisted. Since FDA approval, reports of infants with intussusception following RotaTeq have been received by the Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some infants needed hospitalization, surgery on their intestines, or a special enema to treat this problem. Death due to intussusception has occurred. A study conducted after approval of RotaTeq showed an increased risk of intussusception in the 21 days after the first dose of RotaTeq, but especially in the first 7 days.

  • There are some important things your doctor needs to know about your baby. Tell your doctor if your baby:
  • – Is sick with fever, diarrhea, or vomiting
  • – Is not growing or gaining weight as expected
  • – Has a weakened immune system from a disease (such as cancer, HIV/AIDS or a blood disorder) or from medicine (such as steroids)
  • – Has received a blood transfusion or blood products recently
  • – Was born with gastrointestinal problems, had a blockage, or had abdominal surgery

The spread of vaccine virus to nonvaccinated contacts has been reported. Tell your doctor if you have someone in your household who has a weak immune system, cancer or is taking medications that can weaken the immune system so that your doctor can provide further advice.

Please read the accompanying Patient Information for RotaTeq and discuss it with your doctor. The physician Prescribing Information also is available.


  
  
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