Version May 2024
(For additional information see "Rotavirus vaccines (RV1 and RV5): Pediatric drug information")
Note: Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) for additional information, including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2022]).
Primary immunization:
The ACIP recommends completing the vaccine series with the same product whenever possible. If continuing with same product will cause vaccination to be deferred, or if product used previously is unknown, vaccination should be completed with the product available. If RotaTeq was used in any previous doses, or if the specific product used was unknown, a total of 3 doses should be given (CDC/ACIP [Cortese 2009]).
Rotarix: Note: Product is available in 2 formulations, a ready-to administer oral dose formulation (oral dosing applicator only) and a vial that requires reconstitution prior to administration; dosing varies based on formulation; use caution.
Ready-to-administer formulation (does not require reconstitution): Infants 6 to 24 weeks of age: Oral: 1.5 mL per dose for 2 doses; the first dose may be administered beginning at 6 weeks of age, and the second dose should be administered ≥4 weeks after the first. The 2-dose series should be completed by 24 weeks of age.
Powder for reconstitution (vial for oral use; requires reconstitution): Infants 6 to 24 weeks of age: Oral: 1 mL per dose for 2 doses; the first dose may be administered beginning at 6 weeks of age, and the second dose should be administered ≥4 weeks after the first. The 2-dose series should be completed by 24 weeks of age.
RotaTeq: Infants 6 to 32 weeks of age: Oral: 2 mL per dose for 3 doses, with the first dose given at 6 to 12 weeks of age, followed by subsequent doses at 4- to 10-week intervals. Administer all doses by 32 weeks of age.
ACIP recommendations (CDC/ACIP [Cortese 2009]): The first dose can be given at 6 weeks through 14 weeks 6 days of age. The series should not be started in infants ≥15 weeks. The final dose in the series should be administered by 8 months 0 days of age. The minimum interval between doses is 4 weeks. Rotarix should be given in 2 doses administered at 2 and 4 months of age. RotaTeq should be given in 3 doses administered at 2, 4, and 6 months of age. For infants inadvertently administered rotavirus vaccine at ≥15 weeks of age, the vaccine series may be completed according to schedule. Infants who have had rotavirus gastroenteritis before getting the full course of vaccine should still initiate or complete the recommended schedule; initial infection provides only partial immunity.
Catch-up immunization: ACIP recommendations (CDC/ACIP [Cortese 2009]): Oral: Note: Do not restart the series. If doses have been given, begin the catch-up schedule at the applicable dose number and separate doses by 4 weeks; total of 3 doses. The series should not be started in infants ≥15 weeks 0 days of age. The final dose in the series should be administered by 8 months 0 days of age. For infants inadvertently administered rotavirus vaccine at ≥15 weeks of age, the vaccine series should be completed according to schedule and prior to 8 months 0 days of age. If RotaTeq was used in any previous doses, or if the specific product used was unknown, a total of 3 doses should be given.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in infants.
>10%:
Gastrointestinal: Diarrhea (4% to 24%), vomiting (3% to 15%)
Nervous system: Irritability (11%)
1% to 10%:
Gastrointestinal: Flatulence (2%)
Respiratory: Bronchospasm (1%), nasopharyngitis (7%)
<1%: Gastrointestinal: Intestinal intussusception
Frequency not defined: Nervous system: Seizure
Postmarketing:
Cardiovascular: Kawasaki syndrome
Dermatologic: Urticaria
Gastrointestinal: Hematochezia
Hematologic: Immune thrombocytopenia (Siddiqui 2010)
Hypersensitivity: Anaphylaxis, angioedema
Hypersensitivity to rotavirus vaccine or any component of the formulation; history of uncorrected congenital malformation of the GI tract (such as Meckel diverticulum) that would predispose the infant for intussusception (Rotarix only); history of intussusception; severe combined immunodeficiency disease
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine administration (ACIP [Kroger 2023]).
• Intussusception: An increased risk of intussusception was observed with a previously licensed rotavirus vaccine. Cases have been noted in postmarketing reports and a temporal association has been observed in postmarketing observational studies with current vaccines. Cases were noted within 21 to 31 days of the first dose, with a clustering of cases within the first 7 days following administration. An increased risk was also observed within the first 7 days of the second dose. Use of RotaTeq and Rotarix is contraindicated with a history of intussusception. In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose.
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).
• GI disease: Use with caution in infants with history of GI disorders, acute mild GI illness, chronic diarrhea, failure to thrive, congenital abdominal disorders, and abdominal surgery; vaccine may be used with controlled gastroesophageal reflux disease. ACIP recommends that the vaccine should generally not be administered to infants with acute moderate or severe gastroenteritis (CDC/ACIP [Cortese 2009]). Rotarix is contraindicated with a history of an uncorrected congenital malformation of the GI tract; RotaTeq and Rotarix are contraindicated with a history of intussusception.
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or non-live) for which a person is eligible at a visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2023]).
Special populations:
• Adults: Not intended for use in adults.
• Immunocompromised family members: Virus from live virus vaccines may be transmitted to nonvaccinated contacts; use with caution in the presence of immunocompromised family members. Viral shedding occurs within the first weeks of administration; peak viral shedding generally occurs ~7 days after the first dose. The ACIP recommends vaccination of infants living in households with persons who are immunocompromised (CDC/ACIP [Cortese 2009]).
• Immunocompromised infants: Severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) generally should not receive live vaccines; may have a reduced response to vaccination or may have an adverse event secondary to replication. May be administered with topical corticosteroids or inhaled steroids, or to infants with primary and acquired immunodeficiencies (including HIV/AIDS, cellular immune deficiencies, hypogammaglobulinemic and dysgammaglobulinemic states). Household and close contacts of persons with altered immunocompetence may receive most age-appropriate vaccines. Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live vaccines should not be administered for at least 3 months after immunosuppressive therapy (ACIP [Kroger 2023]). Specific recommendations for use of this vaccine in immunocompromised patients as well as contacts of immunocompromised patients are available from the IDSA (IDSA [Rubin 2014]).
Dosage form specific issues:
• Latex: Some packaging may contain natural latex/natural rubber.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Administration errors have been reported. This vaccine is for oral administration only; doses inadvertently administered by injection are not considered valid and an oral replacement dose should be given according to the appropriate age and schedule (CDC [Hibbs 2014]).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
• Postexposure prophylaxis: Information is not available for use in postexposure prophylaxis.
Safety data with Rotarix in preterm neonates (≤36 weeks GA) showed a similar incidence of serious adverse effects compared to placebo (5.2% vs 5%); no deaths or cases of intussusception were reported in this population. Eye splashes to the provider, parent, or infant have been reported; to minimize risk of coughing, sneezing, and spitting, administer gently inside the cheek (CDC [Hibbs 2014]).
Although the incidence is very low, Kawasaki disease has been observed more frequently in rotavirus vaccine (Rotarix) treatment groups than placebo; based on data from 16 trials, Kawasaki disease was reported in 0.035% of recipients (n=18) of Rotarix group and 0.021% of placebo recipients (n=9). Specific to the placebo-controlled trials, Kawasaki disease was reported in 17 recipients of Rotarix and 9 placebo recipients (RR, 1.71; 95% CI, 0.71 to 4.38). Eleven percent of cases were reported within 30 days postvaccination (range: 3 days to 19 months after vaccine dose). Direct causality has not been established; patients with suspicious clinical presentation should be monitored closely with appropriate diagnostic workup.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Powder, for suspension, oral [preservative free; human derived]:
Rotarix: G1P[8] ≥106 CCID50 per 1 mL [contains sorbitol, sucrose; supplied with diluent which may contain natural rubber/natural latex in packaging]
Solution, oral [preservative free]:
Rotarix: G1P[8] ≥106 CCID50 per 1.5 mL [contains sucrose; packaging of applicators contain nautral rubber latex; human derived]
RotaTeq: G1 ≥2.2 x 106 infectious units, G2 ≥2.8 x 106 infectious units, G3 ≥2.2 x 106 infectious units, G4 ≥2 x 106 infectious units, and P1A [8] ≥2.3 x 106 infectious units per 2 mL (2 mL) [contains sucrose; bovine and human derived]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, oral [human derived]:
Rotarix: ≥106 CCID50 per 1.5 mL (1.5 mL)
Oral: Oral use only; not for injection. May be administered before or after food, milk, or breast milk. To avoid potential eye splashes caused by coughing, sneezing, and spitting, administer gently inside the cheek (CDC [Hibbs 2014]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
Note: Although the Rotarix prescribing information states that a regurgitated or spit out dose may be repeated, the ACIP, AAP, and the RotaTeq prescribing information do not recommend readministering doses. Any remaining dose(s) should be administered on schedule (AAP 2009; ACIP [Kroger 2022]; CDC/ACIP [Cortese 2009]).
Rotarix: Note: The ready-to-administer Rotarix formulation is provided in an oral dosing applicator with an applicator tip cap. The tip cap presents a potential choking hazard and should be removed prior to administration.
Ready-to-administer formulation (does not require reconstitution): Remove tip cap from oral dosing applicator. Infant should be in reclining position. Using oral applicator, administer contents into infant's inner cheek. Dispose of applicator and vaccine vial in biologic waste container.
Vial for reconstitution and oral dosing applicator presentation: Reconstitute vaccine prior to administration. Infant should be in reclining position. Using oral applicator, administer contents into infant's inner cheek. Dispose of applicator and vaccine vial in biologic waste container.
RotaTeq: Gently squeeze dose from ready-to-use dosing tube into infant's mouth toward the inner cheek until dosing tube is empty. After use, dispose of the empty tube and cap in a biologic waste container. Do not mix or dilute vaccine with any other vaccine or solution.
In the US, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient prior to administering each dose of this vaccine; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/rotavirus.html.
Rotavirus gastroenteritis prevention:
Rotarix: Prevention of rotavirus gastroenteritis in infants 6 to 24 weeks of age caused by the serotypes G1, 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 the serotypes G1, G2, G3, G4, and G9 when administered as a 3-dose series.
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all infants (CDC/ACIP [Cortese 2009]).
Rotavirus vaccines (Rotarix and RotaTeq) are only available for ORAL administration. The live oral rotavirus vaccines have been inadvertently administered as an injection, thereby making the vaccine ineffective (ISMP 2014). Avoid the administration of oral rotavirus vaccines as an injection. An oral dose should still be given if the dose was inadvertently administered as an injection (CDC [Hibbs 2014]).
Rotarix is available as 2 formulations; one requires dilution prior to administration and the other is a ready-to-administer prefilled oral syringe.
The ready-to-administer Rotarix formulation is provided in an oral dosing applicator with an applicator tip cap. The tip cap presents a potential choking hazard and should be removed prior to administration (ISMP 2022).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Cladribine: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Cladribine may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider therapy modification
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Teplizumab: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification
Rotavirus vaccine is not indicated for use in women of reproductive age. Infants living in households with pregnant women may be vaccinated (CDC/ACIP [Cortese 2009]).
Infants receiving vaccine may be breastfed (CDC/ACIP [Cortese 2009]).
May be administered before or after food, milk, or breast milk.
A live vaccine; replicates in the small intestine and promotes active immunity to rotavirus gastroenteritis. Rotarix is specifically indicated for prevention of rotavirus gastroenteritis caused by serotypes G1, G3, G4, and G9 and RotaTeq is specifically indicated for prevention of rotavirus gastroenteritis caused by serotypes G1, G2, G3, G4, and G9. However, these vaccines may provide immunity to other rotavirus serotypes.
Note: There is no established relationship between antibody response and protection against gastroenteritis.
Seroconversion:
Rotarix: Antirotavirus IgA antibodies were noted 1 to 2 months following completion of the 2-dose series in 77% to 87% of infants.
RotaTeq: A threefold increase in antirotavirus IgA was noted following completion of the 3-dose regimen in 93% to 100% of infants.
Duration: Following administration of rotavirus vaccine, efficacy of protecting against any grade of rotavirus gastroenteritis through two seasons was 71% to 79%
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