rotavirus oral vaccine, live (Rx)

Brand and Other Names:Rotarix, RotaTeq

Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and rotavirus oral vaccine, live

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      Serious - Use Alternative

        Significant - Monitor Closely

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            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 (66)

            • 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.

            • ritlecitinib

              ritlecitinib, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during or shortly before initiating ritlecitinib. No data are available on vaccination response in ritlecitinib treated patients. Before initiating, review patient immunization status (including herpes zoster) and immunize accordingly in agreement with current immunization guidelines.

            • 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 (7)

            • 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. .

            • delandistrogene moxeparvovec

              delandistrogene moxeparvovec, rotavirus oral vaccine, live. Other (see comment). Use Caution/Monitor. Comment: Consider patient vaccination status before initiating corticosteroid regimen required before delandistrogene moxeparvovec administration. If possible, ensure patients are current with all immunizations according to immunization guidelines. Complete vaccinations at least 4 weeks before starting corticosteroid regimen. High-dose or long-term corticosteroids may decrease immungenicity of vaccines.

            • leniolisib

              leniolisib decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • 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.

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            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

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            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
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            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.

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            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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            Images

            No images available for this drug.
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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.