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RotaTeq

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RotaTeq

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Immunocompromised Populations

No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq 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 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 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.

Vaccine virus transmission from vaccine recipient to non-vaccinated contacts has been reported [see Shedding and Transmission].

Intussusception

Following administration of a previously licensed live rhesus rotavirus reassortant vaccine, an increased risk of intussusception was observed.1

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. [See ADVERSE REACTIONS]

In worldwide passive post-marketing surveillance, cases of intussusception have been reported in temporal association with RotaTeq. [See ADVERSE REACTIONS]

Gastrointestinal Illness

No safety or efficacy data are available for administration of RotaTeq 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, and abdominal surgery. Caution is advised when considering administration of RotaTeq to these infants.

Shedding And Transmission

Shedding of vaccine virus was evaluated among a subset of subjects in the Rotavirus Efficacy and Safety Trial (REST) 4 to 6 days after each dose and among all subjects who submitted a stool antigen rotavirus positive sample at any time. RotaTeq 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 of vaccine virus was not evaluated in phase 3 studies.

Transmission of vaccine virus strains from vaccinees to non-vaccinated contacts has been observed post-marketing.

The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.

Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient close contacts such as:

  • Individuals with malignancies or who are otherwise immunocompromised;
  • Individuals with primary immunodeficiency; or
  • Individuals 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 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.

Incomplete Regimen

The clinical studies were not designed to assess the level of protection provided by only one or two doses of RotaTeq.

Limitations Of Vaccine Effectiveness

RotaTeq may not protect all vaccine recipients against rotavirus.

Post-Exposure Prophylaxis

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

Patient Counseling Information

See FDA-Approved Patient Labeling (PATIENT INFORMATION).

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 WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

RotaTeq 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. It is also not known whether RotaTeq can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RotaTeq 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 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 in infants with controlled gastroesophageal reflux disease.9

REFERENCES

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.

Last reviewed on RxList: 9/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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