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Rotavirus Vaccine Live
- Lyophilized powder for suspension, oral rotavirus vaccine derived from human 89-12 strain (G1P type) and contains at least 10 6 cell culture infective dose per 1 mL (after reconstitution)
- Solution, oral rotavirus outer capsid proteins from the human rotavirus parent strain and the attachment protein (2.2 × 10 6 infectious units of G1, 2.8 × 10 6 infectious units of G2, 2.2 × 10 6 infectious units of G3, 2 × 10 6 infectious units of G4) and 2.3 × 10 6 infectious units of rotavirus attachment protein P1A per 2 mL
Rotavirus vaccine is a live viral vaccine that replicates in the small intestine and induces immunity against rotavirus.
Indications and UsageRotarix
Prevention of rotavirus gastroenteritis in infants 6 to 24 weeks of age caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series.RotaTeq
Prevention of rotavirus gastroenteritis in infants 6 to 32 weeks of age caused by serotypes G1, G2, G3, and G4 when administered as a 3-dose series.
Hypersensitivity to any component of the product; severe combined immunodeficiency disease (SCID); history of uncorrected congenital malformation of the GI tract (eg, Meckel diverticulum) that would predispose the infant for intussusception ( Rotarix only); history of intussusception ( Rotarix only).
Dosage and AdministrationRotarix
Infants 6 to 24 weeks of age
PO 2 doses of 1 mL. Administer the first dose beginning at 6 weeks of age. The interval between the first and second dose should be at least 4 weeks. The 2-dose series should be completed by 24 weeks of age.RotaTeq
Infants 6 to 32 weeks of age
PO Three 2 mL doses administered at 4- to 10-week intervals starting at 6 to 12 weeks of age. Third dose should not be given after 32 weeks of age.
- For oral use. Not for injection.
- Administer without regard to food or liquid, including breast milk.
- Do not dilute or mix with any other oral vaccines or solutions.
- May be coadministered with other licensed pediatric vaccines.
- Reconstitute only with accompanying diluent.
- Administer within 24 h of reconstitution.
- In the event that the infant spits out or regurgitates most of the dose, a single replacement dose may be considered at the same vaccination visit.
- Administer vaccine as soon as possible after removing from refrigerator.
- Do not administer a replacement dose if an incomplete dose is administered for any reason (eg, infant spits out or regurgitates vaccine) because such dosing was not studied. The infant should continue to receive any remaining doses in the recommended series.
Store vials between 36° and 46°F and diluent between 68° and 77°F. Protect vials from light. After reconstitution, may be stored at up to 77°F. Discard reconstituted vaccine if not used within 24 h. Do not freeze. Discard if diluent and/or vaccine has been frozen.RotaTeq
Store between 36° and 46°F. Protect from light.
Drug InteractionsAntineoplastic agents (eg, busulfan), docetaxel, epothilones (eg, ixabepilone), melphalan, nitrosoureas (eg, carmustine), paclitaxel, thiopurines (eg, mercaptopurine), thiotepa
The risk of live rotavirus vaccine–induced severe adverse reactions may be increased by coadministration of live rotavirus vaccine with these agents. Concurrent use of live rotavirus vaccine with 1 of these agents is not recommended under most circumstances. Defer administration of live rotavirus vaccine.Immunosuppressive therapies (eg, alkylating agents, antimetabolites, corticosteroids, cytotoxic drugs, irradiation)
Immune response to vaccines may be reduced. Use with caution.
Irritability (11%); seizure.
Otitis media (15%); nasopharyngitis (7%).
Diarrhea (24%); vomiting (15%); flatulence (2%); gastroenteritis (including severe diarrhea and prolonged shedding of vaccine virus in infants with SCID), hematochezia, intussusception (including death), recurrent intussusception (including death) (postmarketing).
Fever (25%); idiopathic thrombocytopenic purpura, Kawasaki disease, maladministration, transmission of vaccine virus strains to nonvaccinated contacts, urticaria (postmarketing).
Prior to administration, determine current health status and previous vaccination history of the infant, including whether there has been a reaction to a previous dose of this rotavirus vaccine or other types of rotavirus vaccines (eg, rhesus rotavirus–based product).
Category C . Not indicated in women of childbearing age.
Do not administer to breast-feeding women.
Safety and efficacy not established in infants younger than 6 weeks or older than 24 weeks.RotaTeq
Safety and efficacy not established in infants younger than 6 weeks or older than 32 weeks.
Infants developing hypersensitivity symptoms after receiving a dose should not receive further doses.
Delay administration of rotavirus vaccine during febrile illness (fever higher than 100.5°F) unless a health care provider determines that withholding the vaccine entails a greater risk.
Delay administration in infants suffering from acute diarrhea or vomiting. Use with caution in infants with history of GI disorders (eg, abdominal surgery, active acute GI illness, chronic diarrhea, congenital abdominal disorders, failure to thrive, intussusception).
No safety and efficacy data are available for administration of rotavirus vaccine to infants who are potentially immunocompromised.
Immunodeficient close contacts of vaccine recipient
Use caution when considering administration of vaccine to persons with immunodeficient close contacts.
Cases have been reported in temporal association with rotavirus vaccine.
Oral applicator tip cap may contain latex rubber that may cause allergic reactions in latex-sensitive persons.
Level of protection
Level of protection provided by only 1 or 2 doses of RotaTeq has not been established.
There are no clinical data regarding administration of rotavirus vaccine after exposure to rotavirus.
Shedding and transmission
Theoretical risk that live virus vaccine can be transmitted to nonvaccinated contacts. Weigh theoretical risk of vaccine virus transmission against risk of acquiring and transmitting natural rotavirus.
None well documented.
- Provide and review the Vaccine Information Statements prior to immunization.
- Advise parent or caregiver to review the patient information leaflet before vaccine is administered.
- Review immunization schedule.
- Provide parent or guardian with an immunization history record and log this immunization in the patient's immunization record.
- Instruct parent or guardian to immediately report any signs and/or symptoms of intussusception.
- Instruct parent or guardian to contact their health care provider immediately or to go to an emergency department if the infant experiences bloody bowel movements, high fever, severe diarrhea or vomiting, or severe stomach pain.
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