FREQUENTLY ASKED QUESTIONS

• RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 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.

• The vaccination series consists of three 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.

• FOR ORAL USE ONLY. NOT FOR INJECTION.

• The vaccination series consists of three 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 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.

RotaTeq is fully liquid and ready-to-use. It is administered orally. Please see the Dosage and Administration page for full details.

Most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

• Store and transport refrigerated at 2-8°C (36-46°F). RotaTeq should be administered as soon as possible after being removed from refrigeration. For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.

• Protect from light.

• RotaTeq should be discarded in approved biological waste containers according to local regulations.

• The product must be used before the expiration date.

The CPT Code for RotaTeq is 90680.¹⁶

RotaTeq is porcine circoviruses (PCV) free, preservative free, and the plastic dosing tube and cap do not contain latex.

RotaTeq includes 5 live rotavirus strains (G1, G2, G3, G4, and P1A[8]).

Sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, and also trace amounts of fetal bovine serum.

RotaTeq is a 3-dose series that aligns with routine 2-, 4- and 6-month well-baby visits. The first dose of RotaTeq should be administered orally between 6 to 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. Based on the dosing schedule for RotaTeq, the 3-dose series can be completed as early as 14 weeks of age (eg, doses given at 6, 10, and 14 weeks of age).^6,7

The CDC guidelines recommend routine rotavirus vaccination (minimum age: 6 weeks) for RotaTeq^® (Rotavirus Vaccine, Live, Oral, Pentavalent) as a 3-dose series at 2, 4, and 6 months and Rotarix as a 2-dose series at 2 and 4 months.

If any dose in the series is either RotaTeq or unknown, default to the 3-dose series.⁶

The maximum age for the final dose is 8 months, 0 days.⁶

In REST (Study 006), RotaTeq demonstrated efficacy that was robust^a-c

• 98% efficacy against severe RGE caused by G1, G2, G3, and G4
  • (95% CI: 88.3, 100.0); (n=5673: 2834 vaccine; 2839 placebo)
• 74% efficacy against mild, moderate, and severe RGE caused by types G1-4 in Season 1
  • (95% CI: 66.8, 79.9); (n=5673: 2834 vaccine; 2839 placebo)
• 71% efficacy against mild, moderate, and severe RGE caused by types G1-4 through Season 2
  • (95% CI: 64.7, 76.9)
• 96% reduction in hospitalizations due to RGE caused by types G1, G2, G3, and G4 through 2 years postvaccination
  • (95% CI: 90.5, 98.2); (n=68 038: 34 035 vaccine; 34 003 placebo)
• 100% reduction in hospitalizations or ED visits due to RGE caused by G9 through 2 years postvaccination per the post hoc analysis of REST (Study 006)
  • (95% CI: 69.6, 100.0); (n=68 038: 34 035 vaccine; 34 003 placebo)

Study Design for the Rotavirus Efficacy and Safety Trial (Study 006)

REST (Study 006) was a double-blind, placebo-controlled, randomized, multinational trial conducted from 2001 to 2004. Healthy infants 6 to 12 weeks of age were randomized to receive 3 oral doses of RotaTeq or placebo at 4- to 10-week intervals. The primary end point was safety with regard to intussusception (N=68 038), with nested safety (N=9605) and clinical efficacy (N=5673: RotaTeq n=2834, placebo n=2839) substudies.⁹

In Study 029, RotaTeq demonstrated⁸

• 74.5% efficacy against mild, moderate, and severec RGE caused by G1, G2, G3, G4, and G-serotypes associated with type P1A[8] (eg, G9)
  • (95% CI: 39.9, 90.6); (n=761: 380 vaccine; 381 placebo)

Study Design for Study 029

A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial conducted in Japan. Healthy infants 6 to 12 weeks of age were randomized to receive 3 doses of RotaTeq or placebo at 4- to 10-week intervals with the third dose given by 32 weeks of age. The primary end point was efficacy against RGE caused by rotavirus types present in the vaccine (ie, G1, G2, G3, G4, and G-serotypes associated with P1A[8] [eg, G9]), occurring at least 14 days post dose 3.⁸

^aPer protocol analysis.
^bEfficacy end point applies to season 1.
^cSevere gastroenteritis defined by a clinical scoring system based on intensity and duration of symptoms of fever, vomiting, diarrhea, and behavioral changes.

The vaccination series consists of three 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.

Yes, in most states, RotaTeq is available through the Vaccines for Children (VFC) Program for children who qualify. Check with your state or local VFC program to learn more about the specific products available to your practice.

Stocking RotaTeq at your practice does not have to be complicated. Simply register or log in to your account at ordering.merckvaccines.com to get started. You can also begin ordering by calling into the Merck Vaccines Customer Care line 877.VAX.MERCK (877.829.6372), or through your preferred wholesaler/distributor. For a list of Merck authorized distributors please go to Authorized distributors – Merck.com.

If for any reason an incomplete dose is administered (eg, infant spits or regurgitates the vaccine), a replacement dose is not recommended, since such dosing was not studied in the clinical trials. The infant should continue to receive any remaining doses in the recommended series.