Dosage Forms
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; bovine and 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]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
Onset of Action
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 of Action
Following administration of rotavirus vaccine, efficacy of protecting against any grade of rotavirus gastroenteritis through two seasons was 71% to 79%.
Use: Labeled Indications
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]).
Contraindications
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
Dosage and Administration
Dosing: Pediatric
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 2017]).
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: Infants 6 to 24 weeks of age: Oral: 1 mL per dose for 2 doses, the first dose given at 6 weeks of age, followed by the second dose given ≥4 weeks later. 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, 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.
Canadian labeling: Rotarix: Infants 6 to 24 weeks of age: Oral: A total of two 1.5 mL doses, the first dose given at 6 weeks of age, followed by the second dose given ≥4 weeks later. The 2-dose series should be completed by 24 weeks of age.
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 3 doses. The series should not be started in infants ≥15 weeks and 0 days. 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 and 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.
Dietary Considerations
May be administered before or after food, milk, or breast milk.
Storage
Rotarix: Store intact vials under refrigeration at 2°C to 8°C (36°F to 46°F); diluent may be stored under refrigeration at 2°C to 8°C (36°F to 46°F) or at room temperature up to 25°C (77°F). Protect vaccine from light; discard diluent if frozen. Following reconstitution, may be refrigerated at 2°C to 8°C (36°F to 46°F) or stored at room temperature up to 25°C (77°F) for up to 24 hours. Discard if frozen. Note: In Canada, Rotarix is available as an oral suspension ready for use and does not need to be reconstituted. The oral suspension may be stored at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light.
RotaTeq: Store and transport under refrigeration at 2°C to 8°C (36°F to 46°F). Use as soon as possible once removed from refrigerator. Protect from light. Canadian labeling suggests that once the vaccine is removed from refrigeration, it may be stored at temperatures up to 25°C (77°F) for up to 4 hours; do not freeze. Protect from light.
Drug Interactions
Axicabtagene Ciloleucel: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of infection may be increased. Axicabtagene Ciloleucel may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live virus vaccines for at least 6 weeks prior to initiation of lymphodepleting therapy, during axicabtagene ciloleucel infusion, and after treatment until full immune recovery is achieved. Consider therapy modification
AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification
Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification
Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination
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: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this. Consider therapy modification
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Guselkumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; DexAMETHasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination
Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification
Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification
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. Consider therapy modification
Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Risankizumab: May enhance the adverse/toxic effect of Vaccines (Live). 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). Avoid combination
Tisagenlecleucel: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of infection may be increased. Tisagenlecleucel may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live virus vaccines for two weeks prior to initiation of lymphodepleting therapy, during tisagenlecleucel infusion, and after treatment until full immune recovery is achieved. Consider therapy modification
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. Consider therapy modification
Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination
Test Interactions
Tuberculin tests: Rotavirus vaccine may diminish the diagnostic effect of tuberculin tests.
Adverse Reactions
Ranges reported; actual percentage may vary between products.
>10%:
Central nervous system: Irritability (≤52%)
Gastrointestinal: Diarrhea (4% to 24%), vomiting (3% to 15%)
Otic: Otitis media (15%)
Miscellaneous: Fussiness (≤52%)
1% to 10%:
Gastrointestinal: Flatulence (2%)
Respiratory: Nasopharyngitis (7%), bronchospasm (1%)
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, gastroenteritis (with severe diarrhea and prolonged vaccine viral shedding in infants with SCID), hematochezia, immune thrombocytopenia (ITP), intussusception, Kawasaki syndrome, secondary infection (transmission of vaccine virus from recipient to nonvaccinated contacts), seizure, urticaria
Warnings/Precautions
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 2017]).
- 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. Defer 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 2017]).
- 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 inactivated) for which a person is eligible at a single clinic 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 2017]).
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 2017]). 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 2017]). 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. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2017]).
- Postexposure prophylaxis: Information is not available for use in postexposure prophylaxis.
Pregnancy
Pregnancy Considerations
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]).
Patient Education
- Discuss specific use of vaccine and side effects with caregiver as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience irritability, runny nose, lack of appetite, vomiting, abnormal crying, diarrhea, or sore throat. Have caregiver report immediately to prescriber ear pain, wheezing, cough, signs of bowel problems (black, tarry, or bloody stools; fever; mucus in stools; vomiting; vomiting blood; severe abdominal pain; constipation; or diarrhea), or signs of Kawasaki disease (high fever, rash, red eyes or mouth, swollen glands, or swelling in the arms or legs) (HCAHPS).
- Educate caregiver about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Caregiver should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
