Included as part of the PRECAUTIONS section.

Hypersensitivity Reactions

Review infant immunization history for hypersensitivity and other reactions to any component of ROTARIX, including latex rubber contained in the oral applicator. [See DESCRIPTION.]

Gastrointestinal Disorders

Administration of ROTARIX (rotavirus vaccine, live, oral suspension) should be delayed in infants suffering from acute diarrhea or vomiting.

Safety and effectiveness of ROTARIX (rotavirus vaccine, live, oral suspension) in infants with chronic gastrointestinal disorders have not been evaluated. [See CONTRAINDICATIONS.]

Altered Immunocompetence

Safety and effectiveness of ROTARIX (rotavirus vaccine, live, oral suspension) in infants with known primary or secondary immunodeficiencies, including infants with human immunodeficiency virus (HIV), infants on immunosuppressive therapy, or infants with malignant neoplasms affecting the bone marrow or lymphatic system have not been evaluated.

Shedding and Transmission

Rotavirus shedding in stool occurs after vaccination with peak excretion occurring around day 7 after dose 1. Live rotavirus shedding was evaluated in two studies among a subset of infants at day 7 after dose 1. In these studies, the estimated percentages of recipients of ROTARIX who shed live rotavirus were 25.6% (95% Confidence Interval [CI]: 10.2, 41.1) and 26.5% (95% CI: 15.5, 37.5), respectively. Transmission of virus was not evaluated. There is a possibility that the live vaccine virus can be transmitted to non-vaccinated contacts. The potential for transmission of vaccine virus following vaccination should be weighed against the possibility of acquiring and transmitting natural rotavirus.

Intussusception

Following administration of a previously licensed oral live rhesus rotavirus-based vaccine, an increased risk of intussusception was observed.¹ The risk of intussusception with ROTARIX (rotavirus vaccine, live, oral suspension) was evaluated in a safety study (including 63,225 infants) conducted in Latin America and Finland. No increased risk of intussusception was observed in this clinical trial following administration of ROTARIX (rotavirus vaccine, live, oral suspension) when compared with placebo. [See ADVERSE REACTIONS.]

Post-Exposure Prophylaxis

Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluated.

Patient Counseling Information

See FDA-approved patient labeling.

Patient Advice

• Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of immunization with ROTARIX (rotavirus vaccine, live, oral suspension) , and of the importance of completing the immunization series.
• The healthcare provider should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with administration of ROTARIX (rotavirus vaccine, live, oral suspension) or other vaccines containing similar components.
• The parent or guardian accompanying the recipient should be instructed to report any adverse events to their healthcare provider.
• The parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

ROTARIX (rotavirus vaccine, live, oral suspension) has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with ROTARIX (rotavirus vaccine, live, oral suspension) . It is also not known whether ROTARIX (rotavirus vaccine, live, oral suspension) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of ROTARIX (rotavirus vaccine, live, oral suspension) in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated.

The effectiveness of ROTARIX (rotavirus vaccine, live, oral suspension) in pre-term infants has not been established. Safety data are available in pre-term infants (ROTARIX (rotavirus vaccine, live, oral suspension) = 134, placebo = 120) with a reported gestational age ≤ 36 weeks. These pre-term infants were followed for serious adverse events up to 30 to 90 days after dose 2. Serious adverse events were observed in 5.2% of recipients of ROTARIX (rotavirus vaccine, live, oral suspension) as compared with 5.0% of placebo recipients. No deaths or cases of intussusception were reported in this population.

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: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.