rotavirus oral vaccine, live (Rx)

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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
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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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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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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            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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