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RotaTeq

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RotaTeq

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Immunocompromised Populations

No safety or efficacy data are available for the administration of RotaTeq (rotavirus vaccine, live, oral, pentavalent) to 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 (rotavirus vaccine, live, oral, pentavalent) may be administered to infants who are being treated with topical corticosteroids or inhaled steroids.
  • Infants with primary and acquired immunodeficiency states, including HIV/AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. There are insufficient data from the clinical trials to support administration of RotaTeq (rotavirus vaccine, live, oral, pentavalent) to infants with indeterminate HIV status who are born to mothers with HIV/AIDS.
  • Infants who have received a blood transfusion or blood products, including immunoglobulins within 42 days.

No data are available regarding potential vaccine virus transmission from vaccine recipient to non-vaccinated household or other contacts [see WARNINGS AND PRECAUTIONS].

Gastrointestinal Illness

No safety or efficacy data are available for administration of RotaTeq (rotavirus vaccine, live, oral, pentavalent) to infants with a history of gastrointestinal disorders including infants with active acute gastrointestinal illness, infants with chronic diarrhea and failure to thrive, and infants with a history of congenital abdominal disorders, abdominal surgery, and intussusception. Caution is advised when considering administration of RotaTeq (rotavirus vaccine, live, oral, pentavalent) to these infants.

Intussusception

Following administration of a previously licensed live rhesus rotavirus-based vaccine, an increased risk of intussusception was observed.1 In the Rotavirus Efficacy and Safety Trial [REST] (n=69,625), the data did not show an increased risk of intussusception for RotaTeq (rotavirus vaccine, live, oral, pentavalent) when compared to placebo. In post-marketing experience, cases of intussusception have been reported in temporal association with RotaTeq. [See ADVERSE REACTIONS.]

Shedding and Transmission

Shedding was evaluated among a subset of subjects in REST 4 to 6 days after each dose and among all subjects who submitted a stool antigen rotavirus positive sample at any time. RotaTeq (rotavirus vaccine, live, oral, pentavalent) was shed in the stools of 32 of 360 [8.9%, 95% CI (6.2%, 12.3%)] vaccine recipients tested after dose 1; 0 of 249 [0.0%, 95% CI (0.0%, 1.5%)] vaccine recipients tested after dose 2; and in 1 of 385 [0.3%, 95% CI ( < 0.1%, 1.4%)] vaccine recipients after dose 3. In phase 3 studies, shedding was observed as early as 1 day and as late as 15 days after a dose. Transmission was not evaluated.

Caution is advised when considering whether to administer RotaTeq (rotavirus vaccine, live, oral, pentavalent) to individuals with immunodeficient close contacts such as:

  • Individuals with malignancies or who are otherwise immunocompromised; or
  • Individuals receiving immunosuppressive therapy.

RotaTeq (rotavirus vaccine, live, oral, pentavalent) is a solution of live reassortant rotaviruses and can potentially be transmitted to persons who have contact with the vaccine. The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.

Febrile Illness

Febrile illness may be reason for delaying use of RotaTeq (rotavirus vaccine, live, oral, pentavalent) except when, in the opinion of the physician, withholding the vaccine entails a greater risk. Low-grade fever ( ≤ 100.5°F [38.1°C]) itself and mild upper respiratory infection do not preclude vaccination with RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Incomplete Regimen

The clinical studies were not designed to assess the level of protection provided by only one or two doses of RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Limitations of Vaccine Effectiveness

RotaTeq (rotavirus vaccine, live, oral, pentavalent) may not protect all vaccine recipients against rotavirus.

Post-Exposure Prophylaxis

No clinical data are available for RotaTeq (rotavirus vaccine, live, oral, pentavalent) when administered after exposure to rotavirus.

Patient Counseling Information

[See FDA-Approved Patient Labeling .]

Information for Parents/Guardians

Parents or guardians should be given a copy of the required vaccine information and be given the “Patient Information” appended to this insert. Parents and/or guardians should be encouraged to read the patient information that describes the benefits and risks associated with the vaccine and ask any questions they may have during the visit. See PRECAUTIONS and PATIENT INFORMATION.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

RotaTeq (rotavirus vaccine, live, oral, pentavalent) has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with RotaTeq (rotavirus vaccine, live, oral, pentavalent) . It is also not known whether RotaTeq (rotavirus vaccine, live, oral, pentavalent) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RotaTeq (rotavirus vaccine, live, oral, pentavalent) is not indicated in women of child-bearing age and should not be administered to pregnant females.

Pediatric Use

Safety and efficacy have not been established in infants less than 6 weeks of age or greater than 32 weeks of age.

Data are available from clinical studies to support the use of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in pre-term infants according to their age in weeks since birth [see ADVERSE REACTIONS].

Data are available from clinical studies to support the use of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in infants with controlled gastroesophageal reflux disease.

1. Murphy TV, Gargiullo PM, Massoudi MS et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001;344:564-572.

2. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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