Rotateq

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  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Rotateq Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Pentavalent, live rotavirus vaccine; oral susp; contains fetal bovine serum (trace); preservative-free.

    How Supplied

    Single-use tube (2mL)—10, 25

    Storage

    • Store and transport refrigerated at 2-8°C (36-46°F). RotaTeq should be administered as soon as possible after being removed from refrigeration. Protect from light.

    Manufacturer

    Merck & Co., Inc.

    Mechanism of Action

    The exact immunologic mechanism by which RotaTeq protects against rotavirus gastroenteritis is unknown. RotaTeq is a live viral vaccine that replicates in the small intestine and induces immunity.

    Rotateq Indications

    Indications

    Rotavirus gastroenteritis vaccination in infants 6–32 weeks of age.

    Rotateq Dosage and Administration

    Adult

    Not recommended.

    Children

    <6 weeks or >32 weeks: not established. Each dose is 1 tube. Give 1st dose orally at 6–12 weeks of age; give 2nd and 3rd dose at 4–10 week intervals for a total of 3 doses. If incomplete dose is given, do not give replacement dose; continue with remaining doses in the recommended series.

    Rotateq Contraindications

    Contraindications

    Severe combined immunodeficiency disease. History of intussusception.

    Rotateq Boxed Warnings

    Not Applicable

    Rotateq Warnings/Precautions

    Warnings/Precautions

    Immunocompromised (blood dyscrasias, leukemia, lymphomas, or other malignancies; primary and acquired immunodeficiency states, HIV/AIDS; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states; received blood transfusion or blood products, including immunoglobulins within 42 days). Febrile illness. Active or history of GI disorders. Chronic diarrhea. Failure to thrive. History of congenital abdominal disorders. Abdominal surgery. Risk of intussusception. Immunodeficient close contacts. Pregnancy (Cat. C), women of child-bearing potential: not recommended.

    Warnings/Precautions

    Managing Allergic Reactions

    • Have appropriate medical treatment and supervision available to manage possible anaphylactic reactions following administration.

    Immunocompromised Populations

    • Safety and effectiveness of RotaTeq have not been established in infants who are potentially immunocompromised including:

      • Infants with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system.

      • Infants on immunosuppressive therapy (including high-dose systemic corticosteroids). RotaTeq may be administered to infants who are being treated with topical corticosteroids or inhaled steroids.

      • Infants with known primary or secondary immunodeficiencies, including HIV/AIDS or other clinical manifestations of infection with HIV; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. 

      • Infants who have received a blood transfusion or blood products, including immunoglobulins within 42 days.

    • Transmission of vaccine virus from recipient to nonvaccinated contacts have been reported.

    Intussusception

    • Increased risk of intussusception.

    • In postmarketing observational studies, there were cases of intussusception observed in temporal association with RotaTeq, with a clustering of cases in the first 7 days.

    Gastrointestinal Illness

    • Safety and effectiveness of RotaTeq have not been evaluated in infants with a history of GI disorders including those with active acute GI illness, infants with chronic diarrhea and failure to thrive, and infants with a history of congenital abdominal disorders, and abdominal surgery.

    • Use caution when considering administration of RotaTeq to these infants.

    Shedding and Transmission

    • Weight the potential for transmission of vaccine virus after administration against the risk of acquiring and transmitting natural rotavirus.

    • Use caution when administering to individuals with immunodeficient close contacts (eg, those with malignancies or immunocompromised, primary immunodeficiency, or receiving immunosuppressive therapy).

    Febrile Illness

    • Febrile illness may be reason for delaying use of RotaTeq, except when in the opinion of the physician, withholding the vaccine causes greater risk.

    • Low-grade fever (<100.5°F [38.1°C]) itself and mild upper respiratory infection do not preclude vaccination with RotaTeq.

    Limitations of Vaccine Effectiveness

    • May not protect all vaccine recipients against rotavirus.

    Post-Exposure Prophylaxis

    • No available data for RotaTeq when administered after exposure to rotavirus.

    Pregnancy Considerations

    • Not approved for individuals 32 weeks of age and older.

    • No available data to assess vaccine-associated risks in pregnancy.

    Nursing Mother Considerations

    • No available data to assess the impact of RotaTeq on milk production, its presence in breast milk, or its effect on the breastfed infant.

    Pediatric Considerations

    • Safety and efficacy of RotaTeq have not been established in infants <6 weeks of age or >32 weeks of age.

    Rotateq Pharmacokinetics

    See Literature

    Rotateq Interactions

    Interactions

    Immunosuppressants (eg, irradiation, chemotherapy, high-dose steroids): may get suboptimal response. Concomitant vaccines: see full labeling; oral polio vaccine: not recommended.

    Interactions

    Immunosuppressive Therapy

    • Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids [used in greater than physiologic doses]) may reduce the immune response to vaccines.

    Concomitant Vaccine Administration

    • In clinical trials, there was no evidence for reduced antibody responses when RotaTeq was concomitantly administered with diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine.

    Rotateq Adverse Reactions

    Adverse Reactions

    Diarrhea, vomiting, irritability, otitis media, nasopharyngitis, bronchospasm; rare: intussusception, hematochezia, seizures, Kawasaki disease.

    Rotateq Clinical Trials

    Clinical Trials

    • 4 placebo-controlled phase 3 studies conducted in 12 countries evaluated the efficacy of RotaTeq in preventing rotavirus gastroenteritis in 73,086 healthy infants. Patients received a 3-dose series of RotaTeq with the first dose administered between 6 and 12 weeks of age then the 2 additional doses at 4- to 10-week intervals. Oral polio vaccine administration was not permitted.

    • The primary efficacy analyses included cases of rotavirus gastroenteritis caused by types G1, G2, G3, G4 (and G types containing P1A8 (in Study 029 only)) that occurred at least 14 days after the third dose through the first rotavirus season post vaccination. 

    • Analyses were also done to evaluate the efficacy of RotaTeq against rotavirus gastroenteritis caused by any of types G1, G2, G3, and G4 (and G types containing P1A8 (in Study 029 only)) at any time following the first dose through the first rotavirus season post-vaccination among infants who received at least one vaccination (Intent-to-treat, ITT).

    Rotavirus Efficacy and Safety Trial (Study 006)

    • Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring types G1, G2, G3, or G4 through the first rotavirus season after vaccination was 74.0% (95% CI, 66.8-79.9) and the ITT efficacy was 60.0% (95% CI, 51.5-67.1).

    • Primary efficacy against severe rotavirus gastroenteritis caused by naturally occurring types G1, G2, G3, or G4 through the first rotavirus season after vaccination was 98.0% (95% CI, 88.3-100.0), and ITT efficacy was 96.4% (95% CI, 86.2-99.6).

    • The vaccine efficacy of RotaTeq was 95.8% (95% CI, 90.5-98.2) in reducing hospitalizations for rotavirus gastroenteritis caused by types G1, G2, G3, and G4 through the first two years after the third dose. The ITT efficacy was 94.7% (95% CI, 89.3-97.3).

    Study 007

    • Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring types G1, G2, G3, or G4 through the first rotavirus season after vaccination was 72.5% (95% CI, 50.6-85.6) and the ITT efficacy was 58.4% (95% CI, 33.8-74.5).

    • Primary efficacy against severe rotavirus gastroenteritis caused by naturally occurring types G1, G2, G3, or G4 through the first rotavirus season after vaccination was 100% (95% CI, 13.0-100.0) and ITT efficacy against severe rotavirus disease was 100% (95% CI, 30.2-100.0).

    Multiple Rotavirus Seasons – Study 006

    • Efficacy against any grade of severity of rotavirus gastroenteritis caused by rotavirus types G1, G2, G3, and G4 through the two rotavirus seasons after vaccination was 71.3% (95% CI, 64.7-76.9). 

    • The efficacy of RotaTeq in preventing cases occurring only during the second rotavirus season post-vaccination was 62.6% (95% CI, 44.3-75.4).

    Rotavirus Gastroenteritis Regardless of Type

    • In Study 006, the efficacy of RotaTeq against any grade of severity of naturally occurring rotavirus gastroenteritis regardless of type was 71.8% (95% CI, 64.5-77.8) and efficacy against severe rotavirus disease was 98.0% (95% CI, 88.3-99.9). The ITT efficacy starting at dose 1 was 50.9% (95% CI, 41.6-58.9) for any grade of severity of rotavirus disease and was 96.4% (95% CI, 86.3-99.6) for severe rotavirus disease.

    • In Study 007, the primary efficacy of RotaTeq against any grade of severity of rotavirus gastroenteritis regardless of type was 72.7% (95% CI, 51.9-85.4) and efficacy against severe rotavirus disease was 100% (95% CI, 12.7-100). The ITT efficacy starting at dose 1 was 48.0% (95% CI, 21.6-66.1) for any grade of severity of rotavirus disease and was 100% (95% CI, 30.4-100.0) for severe rotavirus disease.

    Rotavirus Gastroenteritis by Type

    • In Study 029 (a Phase 3 randomized, blinded, placebo-controlled study conducted in Japan), efficacy on the pre-specified primary endpoint (rotavirus gastroenteritis caused by G1, G2, G3, G4, and G-serotypes associated with serotype P1A[8] (eg, G9)) was 74.5% (95% CI, 39.9-90.6). G9P1A[8]-associated gastroenteritis was observed in 0/356 and 5/354 subjects in the RotaTeq and placebo groups, respectively (100% [95% CI, -9.0, 100]).

    • In a post hoc analysis of health care utilization data from 68,038 infants (RotaTeq 34,035 and placebo 34,003) in Study 006, using a case definition that included culture confirmation, hospitalization and emergency departments visits for rotavirus gastroenteritis, cases due to G9P1A[8] were reduced (RotaTeq 0 cases: placebo 14 cases) by 100% (95% CI, 69.6-100.0).

    Immunogenicity

    • In phase 3 studies, 92.9% to 100% of 439 recipients of RotaTeq achieved a 3-fold or more rise in serum anti-rotavirus IgA after a three-dose regimen when compared to 12.3%-20.0% of 397 placebo recipients.

    Rotateq Note

    Not Applicable

    Rotateq Patient Counseling

    See Literature

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