Dosing & Uses
Not indicated
Dosage Forms & Strengths
oral vaccine
Rotarix
- Monovalent
- 89-12 strain (G1P[8] type); ≥10^6 cell culture infective dose
RotaTeq
- Pentavalent
- G1 ≥2.2 × 10^6 infectious units
- G2 ≥2.8 × 10^6 infectious units
- G3 ≥2.2 × 10^6 infectious units
- G4 ≥2 × 10^6 infectious units
- P1A [8] ≥2.3 × 10^6 infectious units of rotavirus attachment protein
Rotavirus Gastroenteritis Prophylaxis
Live, attenuated oral vaccine indicated for immunization to prevent rotavirus gastroenteritis in infants and children
RotaTeq: 3 Dose Regimen
- Pentavalent vaccine; prevention of rotavirus gastroenteritis caused by the G1, G2, G3, and G4 serotypes, plus attachment protein serotype P7
- Total of three 2 mL doses administered orally
- First dose given at 6-12 weeks of age
- Subsequent doses administered at 4-10 week intervals
- Third dose should not be given after 32 weeks of age
Rotarix: 2-Dose Regimen
- Prevention of rotavirus gastroenteritis caused by G1 and non-G1 serotypes (G3, G4, and G9)
- Total of two 1 mL doses administered orally
- Administer first dose to infants beginning at 6 weeks of age
- Administer second dose after an interval of at least 4 weeks and prior to 24 weeks of age
Supporting Data
CDC researchers observed rotavirus-associated diarrhea decreased by 75% and hospitalizations for diarrhea by 33% during 2007-2008 following 2006 introduction of pentavalent rotavirus vaccine; diarrhea-related incidence also decreased among age-matched unvaccinated children (NEJM 2011 Sept22;365:1108-1117)
Up-to-date vaccination schedules available at www.cdc.gov/nip/publications
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (14)
- belimumab
belimumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- certolizumab pegol
certolizumab pegol decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.
- ibrutinib
ibrutinib decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.
- ifosfamide
ifosfamide decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.
- ixekizumab
ixekizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- lomustine
lomustine decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- mechlorethamine
mechlorethamine decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.
- melphalan
melphalan decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.
- methotrexate
methotrexate decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunization with live virus vaccines is generally not recommended.
- onasemnogene abeparvovec
onasemnogene abeparvovec decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.
- oxaliplatin
oxaliplatin decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.
- procarbazine
procarbazine decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.
- secukinumab
secukinumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Secukinumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating secukinumab, complete all age appropriate immunizations.
- ustekinumab
ustekinumab decreases effects of rotavirus oral vaccine, live by Mechanism: pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Serious - Use Alternative (65)
- abrocitinib
abrocitinib decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administration of live vaccines is not recommended during abrocitinib treatment and immediately before or after treatment.
- adalimumab
adalimumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- alefacept
alefacept decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- anakinra
anakinra decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- anifrolumab
anifrolumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- antithymocyte globulin equine
antithymocyte globulin equine decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- atoltivimab/maftivimab/odesivimab
atoltivimab/maftivimab/odesivimab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- axicabtagene ciloleucel
axicabtagene ciloleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.
- azathioprine
azathioprine decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- baricitinib
baricitinib decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- basiliximab
basiliximab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- brexucabtagene autoleucel
brexucabtagene autoleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.
- budesonide
budesonide decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- cabazitaxel
cabazitaxel decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.
- canakinumab
canakinumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ciltacabtagene autoleucel
ciltacabtagene autoleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- cortisone
cortisone decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- cyclosporine
cyclosporine decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Avoid live vaccines in immunocompromised patients due to the risk of developing a clinical infection from the live vaccine. Inadequate immune response to the vaccine may also occur in the presence of immunosuppressants. Avoid live vaccines for at least 3 months after cessation of immunosuppressant therapy unless the benefit of vaccine administration outweighs the potential risk.
- deflazacort
deflazacort decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
deflazacort decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. - dexamethasone
dexamethasone decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- elivaldogene autotemcel
elivaldogene autotemcel, rotavirus oral vaccine, live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- etanercept
etanercept decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- everolimus
everolimus decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- fingolimod
fingolimod decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.
- fludrocortisone
fludrocortisone decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- glatiramer
glatiramer decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- golimumab
golimumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- guselkumab
guselkumab, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- hydrocortisone
hydrocortisone decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hydroxyurea
hydroxyurea decreases effects of rotavirus oral vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- idecabtagene vicleucel
idecabtagene vicleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- infliximab
infliximab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- leflunomide
leflunomide decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- mercaptopurine
mercaptopurine decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- methylprednisolone
methylprednisolone decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- muromonab CD3
muromonab CD3 decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- mycophenolate
mycophenolate decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ocrelizumab
ocrelizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- ofatumumab SC
ofatumumab SC decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ofatumumab SC for live or live-attenuated vaccines, and whenever possible.
- ozanimod
ozanimod decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live-attenuated vaccines with ozanimod during treatment and for up to 3 months after discontinuing ozanimod. .
- ponesimod
ponesimod decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live attenuated vaccines at least 1 month before initiating, during, and for 1-2 weeks after treatment. Coadministration with live attenuated vaccines may increase infection risk.
- prednisolone
prednisolone decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- prednisone
prednisone decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- rilonacept
rilonacept decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- risankizumab
risankizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- rituximab
rituximab, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.
- rituximab-hyaluronidase
rituximab-hyaluronidase, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.
- sarilumab
sarilumab, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- satralizumab
satralizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.
- siponimod
siponimod decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.
- sirolimus
sirolimus decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
tacrolimus decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- temsirolimus
temsirolimus decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- teplizumab
teplizumab decreases effects of rotavirus oral vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.
- tildrakizumab
tildrakizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- tisagenlecleucel
tisagenlecleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- tocilizumab
tocilizumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tralokinumab
tralokinumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- upadacitinib
upadacitinib decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ustekinumab
ustekinumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- vedolizumab
vedolizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.
- voclosporin
voclosporin decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines. Avoid live vaccines for at least 3 months after immunosuppressants.
Monitor Closely (5)
- anthrax immune globulin
anthrax immune globulin decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Immune globulin administration may impair the efficacy of live attenuated vaccines. Defer vaccination with live virus vaccines until ~3 months after administration of anthrax IG. Revaccinate people who received anthrax IG shortly after live virus vaccination following 3 months after the administration of anthrax IG.
- belatacept
belatacept decreases effects of rotavirus oral vaccine, live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- betibeglogene autotemcel
betibeglogene autotemcel, rotavirus oral vaccine, live. Other (see comment). Use Caution/Monitor. Comment: Follow institutional guidelines for vaccine administration. Safety of live vaccines during or following treatment not studied. .
- obinutuzumab
obinutuzumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.
- ublituximab
ublituximab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.
Minor (1)
- chloroquine
chloroquine decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Minor/Significance Unknown.
Adverse Effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
Within 42 days of any dose
>10%
Diarrhea (24.1%)
Vomiting (15.2%)
Otitis media (14.5%)
Fever (17-43%)
Fussiness/irritability (3-52%)
1-10%
Nasopharyngitis (6.9%)
Bronchospasm (1.1%)
Faltulence (2%)
Postmarketing Reports
Gastroenteritis with vaccine viral shedding in infants with severe combined immunodeficiency disease (SCID)
Hematochezia
Thrombocytopenia (immune)
Urticaria
Intussusception within first 31 days following first dose (particularly within first 7 days)
Kawasaki disease
Warnings
Contraindications
Hypersensitivity
Immunosuppression
Infants with severe combined immunodeficiency disease (SCID)
Infants aged <6 weeks and >32 weeks
History of uncorrected congenital malformation of the GI tract that would predispose infant to intussusception
Infants with a history of intussusception
Cautions
Do not reconstitute or dilute
Pospone administration in moderate or severe acute illness (with or without fever)
Caution with history of GI disorders
Not for use in adults
Use caution when administered in presence of immunocompromised family members (viral shedding occurs within the first weeks of administration)
Safety and efficacy not established for use in immunocompromised infants
Postmarketing reports of Kawasaki disease in some recipient infants
Effectiveness unknown for postexposure prophylaxis
Vaccination may not result in effective immunity in all patients
Intussusception
- Postmarketing reports of intussusception and hematochezia; interim postmarketing safety data from study suggest increased risk of intussusception in the 31 days following first dose (most often within the first 7 days)
- Intussusception incidence in U.S. is estimated to be 1 to 5 cases per 100,000 vaccinees In a study of 1.5 million infants, the monovalent vaccine showed a relative risk of 8.4 and the pentavalent vaccine did not show increased risk compared with historical background rates of intussesception; N Engl J Med Jan 2014
- Another study observed an increased risk with the pentavalent vaccine, but was underpowered to evaluate the monovalent form and involved ~600,000 infant-years; N Engl J Med Jan 2014
Pregnancy & Lactation
Pregnancy Category: Not for use in adults
Lactation: Not for use in adults
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Live, attenuated vaccine; following immunization, immunogenicity occurs by antibody response; seroconversion is defined as antirotavirus IgA antibodies >20 U/mL post-vaccination; conveys active immunity via stimulation of production of endogenously produced antibodies
Replicates in small intestine and incudes immunity
Rotarix is indicated for prevention of rotavirus gastroenteritis caused by serotypes G1, G3, G4, and G9; RotaTeq is indicated for gastroenteritis caused by serotypes G1, G2, G3, and G4; both vaccines may provide immunity to other serotypes
Pharmacokinetics
Onset: Antirotavirus IgA antibodies noted 1-2 months in 77-87% of infants after 2 doses administered for Rotarix; antirotavirus antibodies noted after 3 doses in 93-100% of infants for RotaTeq
Duration: Efficacy was at 70-79% against any grade of rotavirus through two seasons
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