"June 15, 2011 -- A vaccine that prevents the most common cause of severe diarrhea and dehydration in babies was associated with a potentially life-threatening bowel disorder in a large study from Mexico and Brazil, but the risk was small."...
The tip caps of the prefilled oral applicators of diluent may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
Administration of ROTARIX should be delayed in infants suffering from acute diarrhea or vomiting.
Safety and effectiveness of ROTARIX 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 established.
Shedding And Transmission
One clinical trial demonstrated that vaccinees transmit vaccine virus to healthy seronegative contacts [see CLINICAL PHARMACOLOGY].
The potential for transmission of vaccine virus following vaccination should be weighed against the possibility of acquiring and transmitting natural rotavirus. Caution is advised when considering whether to administer ROTARIX to individuals with immunodeficient close contacts, such as individuals with malignancies, primary immunodeficiency or receiving immunosuppressive therapy.
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 was evaluated in a pre-licensure randomized, placebo-controlled 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 when compared with placebo. [See ADVERSE REACTIONS]
In a postmarketing, observational study conducted in Mexico, cases of intussusceptions were observed in temporal association within 31 days following the first dose of ROTARIX, with a clustering of cases in the first 7 days. [See ADVERSE REACTIONS]
Other postmarketing observational studies conducted in Brazil and Australia also suggest an increased risk of intussusception within the first 7 days following the second dose of ROTARIX.2,3 [See ADVERSE REACTIONS]
In worldwide passive postmarketing surveillance, cases of intussusception have been reported in temporal association with ROTARIX [see ADVERSE REACTIONS].
Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluated.
Patient Counseling Information
See FDA-approved patient labeling (PATIENT INFORMATION). Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.
- Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of immunization with ROTARIX, 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 or other vaccines containing similar components.
- The parent or guardian should immediately report any signs and/or symptoms of intussusception.
- 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).
Carcinogenesis, Mutagenesis, Impairment Of Fertility
ROTARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Use In Specific Populations
Pregnancy Category C
Animal reproduction studies have not been conducted with ROTARIX. It is also not known whether ROTARIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Safety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated.
The effectiveness of ROTARIX in pre-term infants has not been established. Safety data are available in pre-term infants (ROTARIX = 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 as compared with 5.0% of placebo recipients. No deaths or cases of intussusception were reported in this population.
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. Carlin JB, Macartney KK, Lee KJ, et al. Intussusception Risk and Disease Prevention Associated with Rotavirus Vaccines in Australia's National Immunization Program. CID 2013;57(10): 1427-1434.
3. Patel MM, Lopez-Collada VR, Bulhoes MM, et al. Intussusception Risk and Health Benefits of Rotavirus Vaccination in Mexico and Brazil. NEngl J Med 2011;364:2283-2292.
Last reviewed on RxList: 9/26/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Rotarix Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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