- Use Alternative (1)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. .tocilizumabSerious - Use Alternative (1)tocilizumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.tralokinumabSerious - Use Alternative (1)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 suspensionSerious - Use Alternative (1)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.ublituximabMonitor Closely (1)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.upadacitinibSerious - Use Alternative (1)upadacitinib decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.ustekinumabContraindicated (1)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 (1)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.vedolizumabSerious - Use Alternative (1)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.voclosporinSerious - Use Alternative (1)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. 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 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 Category: Not for use in adults Lactation: Not for use in adultsPregnancy 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. 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 No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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