Rotarix

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  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Rotarix Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Live, attenuated human G1P[8] rotavirus vaccine contains at least 106.0 CCID50 per dose; lyophilized pwd for oral use after reconstitution (vial and oral dosing applicator presentation); susp for oral use (oral dosing applicator only presentation); preservative-free.

    How Supplied

    Vials—10 (w. prefilled diluent in oral applicator); Prefilled oral dosing applicator—10

    How Supplied

    Rotarix Vial and Oral Dosing Applicator Presentation

    • The Rotarix vial and oral dosing applicator presentation is supplied as single-dose vials of lyophilized vaccine component, accompanied by a prefilled oral dosing applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution.

    • Supplied as an outer package of 10 doses containing:

      • Inner package of 10 vials of lyophilized vaccine component

      • Oral dosing applicator of diluent

    Rotarix Oral Dosing Applicator Only Presentation

    • The Rotarix oral dosing applicator only presentation is supplied as a single 1.5 mL dose in a prefilled oral dosing applicator with a plunger stopper in a carton of 10.

    Storage

    Rotarix Vial and Oral Dosing Applicator Presentation

    • Storage before reconstitution

      • Lyophilized vaccine component in vials: Store refrigerated at 2° to 8°C (36° to 46°F). Protect vials from light.

      • Diluent in oral dosing applicators: Store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Do not freeze. Discard if the diluent has been frozen.

    • Storage after reconstitution

      • Administer within 24 hours after reconstitution.

      • After reconstitution, store at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Discard if not used within 24 hours. Do not freeze. Discard if the reconstituted vaccine has been frozen.

    Rotarix Oral Dosing Applicator Only Presentation

    • Store refrigerated at 2° to 8°C (36° to 46°F). Do not freeze. Discard if the vaccine has been frozen. Keep in original package to protect from light.

    Manufacturer

    GlaxoSmithKline

    Generic Availability

    NO

    Mechanism of Action

    Rotarix contains a live, attenuated human rotavirus that replicates in the small intestine and induces immunity.

    Rotarix Indications

    Indications

    Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children.

    Rotarix Dosage and Administration

    Adult

    Not applicable.

    Children

    <6 weeks or >24 weeks of age: not recommended. Each oral dose is 1mL (in vial and oral dosing applicator) or 1.5mL (in oral dosing applicator only). Give 1st dose beginning at 6 weeks of age, 2nd dose at least 4 weeks later; complete 2-dose series by 24th week of age. May give a replacement dose at same vaccination visit if dosing is incomplete or regurgitated.

    Children

    Dosing and Schedule

    • <6 weeks or >24 weeks of age: not recommended. 

    • Each oral dose is 1mL (in vial and oral dosing applicator) or 1.5mL (in oral dosing applicator only). 

    • Give 1st dose beginning at 6 weeks of age, 2nd dose at least 4 weeks later; complete 2-dose series by 24th week of age. 

    • Safety and efficacy have not been established if Rotarix were administered for the first dose and another rotarix vaccine were administered for the second dose or vice versa.

    • May give a replacement dose at same vaccination visit if dosing is incomplete or regurgitated.

    Infant Feeding

    • In clinical studies, breastfeeding was permitted.

    • Evidence did not suggest that breastfeeding reduced the protection against rotavirus gastroenteritis afforded by Rotarix. There are no restrictions on the infant’s liquid consumption, including breast milk, either before or after vaccination with Rotarix.

    Administration

    For oral use only. Reconstitute with accompanying diluent. Do not mix with other vaccines or solutions. If infant spits out or regurgitates most of vaccine dose, a single replacement dose may be considered at the same vaccination visit.

    Nursing Considerations

    For oral use only. Reconstitute with accompanying diluent. Do not mix with other vaccines or solutions. If infant spits out or regurgitates most of vaccine dose, a single replacement dose may be considered at the same vaccination visit. Discard reconstituted vaccine if not used within 24hrs.

    Rotarix Contraindications

    Contraindications

    Uncorrected congenital GI tract malformation (eg, Meckel's diverticulum) (increased risk of intussusception). History of intussusception. Severe combined immunodeficiency disease.

    Rotarix Boxed Warnings

    Not Applicable

    Rotarix Warnings/Precautions

    Warnings/Precautions

    Acute diarrhea or vomiting (delay immunization). Chronic GI disorders. Immunodeficiency or immunosuppressed close contacts (live virus shedding may allow transmission to others). Latex allergy. Pregnancy: not applicable.

    Warnings/Precautions

    Latex

    • The tip caps of the prefilled oral dosing applicators contain natural rubber latex which may cause allergic reactions.

    Gastrointestinal Disorders

    • Delay administration of Rotarix in infants suffering from acute diarrhea or vomiting.

    • Safety and effectiveness of Rotarix have not been evaluated in infants with chronic GI disorders.

    Altered Immunocompetence

    • Safety and effectiveness of Rotarix have not been established in infants with known primary or secondary immunodeficiencies, including infants with HIV, infants on immunosuppressive therapy, or infants with malignant neoplasms affecting the bone marrow or lymphatic system.

    Shedding and Transmission

    • Rotavirus shedding in stool occurs after vaccination with peak excretion occurring around Day 7 after Dose 1.

    • Weight the potential for transmission of vaccine virus after administration against the risk of acquiring and transmitting natural rotavirus.

    • Use caution when administering to individuals with immunodeficient close contacts (eg, those with malignancies, primary immunodeficiency, or receiving immunosuppressive therapy).

    Intussusception

    • Increased risk for intussusception after administration. 

    • In postmarketing observational studies, there were cases of intussusception observed in temporal association after the first dose of Rotarix, with a clustering of cases in the first 7 days.

    Post-Exposure Prophylaxis

    • Safety and effectiveness of Rotarix when administered after exposure to rotavirus have not been evaluated.

    Pediatric Considerations

    • Safety and effectiveness of Rotarix in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated.

    Rotarix Pharmacokinetics

    See Literature

    Rotarix Interactions

    Interactions

    May give with concomitant vaccines (eg, DTaP, Hep B, Inactivated Poliovirus Vaccine Combined, Hib conjugate). Immunosuppressants (eg, irradiation, chemotherapy, high-dose steroids): may get suboptimal response.

    Rotarix Adverse Reactions

    Adverse Reactions

    Fussiness/irritability, cough/runny nose, fever, loss of appetite, vomiting, diarrhea, dehydration, pneumonia; rare: Kawasaki disease.

    Rotarix Clinical Trials

    Clinical Trials

    Efficacy was evaluated using the reconstituted lyophilized formulation. These data are relevant to the liquid formulation because both formulations contain the same live, attenuated rotavirus strain and are manufactured using a similar process.

    Efficacy Studies

    Study 5

    • The randomized, double-blind, placebo-controlled study was conducted in 6 European countries which included 3994 healthy infants who received a 2-dose series of Rotarix (n=2646) or placebo (n=1348). The first dose was administered from 6 to 14 weeks of age then the second dose was administered at least 4 weeks after. The 2-dose series was completed by 24 weeks of age.

    • The primary endpoint was prevention of any grade of severity of rotavirus gastroenteritis caused by naturally occurring rotavirus from 2 weeks after the second dose through one rotavirus season (according to protocol, ATP). Analyses were also done to evaluate the efficacy of Rotarix against rotavirus gastroenteritis among infants who received at least one vaccination (total vaccinated cohort, TVC).

    • The vaccine efficacy of Rotarix was 87.1% (95% CI, 79.6-92.1) against any grade of severity of rotavirus gastroenteritis through one rotavirus season. The TVC efficacy was 87.3% (95% CI, 80.3-92.0).

    • The vaccine efficacy of Rotarix was 95.8% (95% CI, 89.6-98.7) against severe rotavirus gastroenteritis through one rotavirus season. The TVC efficacy was 96.0% (95% CI, 90.2-98.8).

    • The protective effect of Rotarix against any grade of severity of rotavirus gastroenteritis observed immediately following Dose 1 administration and prior to Dose 2 was 89.8% (95% CI, 8.9-99.8).

    • 100% (95% CI, 81.8-100) vaccine efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through one rotavirus season. The TVC efficacy was 100% (95% CI, 81.7-100). Rotarix reduced hospitalizations for all-cause gastroenteritis regardless of presumed etiology by 74.7% (95% CI, 45.5-88.9).

    Study 8

    • The randomized, double-blind, placebo-controlled study was conducted in 11 countries in Latin America and Finland which included 63,225 healthy infants who received a 2-dose series of Rotarix (n=10,159) or placebo (n=10,010). The first dose was administered from 6 to 13 weeks of age then the second dose was administered at least 4 weeks after. The 2-dose series was completed by 24 weeks of age.

    • The primary endpoint was prevention of severe rotavirus gastroenteritis caused by naturally occurring rotavirus from 2 weeks after the second dose through one year (ATP). Analyses were done to evaluate the efficacy of Rotarix against severe rotavirus gastroenteritis among infants who received at least one vaccination (TVC).

    • The vaccine efficacy of Rotarix was 84.7% (95% CI, 71.7-92.4) against severe rotavirus gastroenteritis through 1 year. The TVC efficacy was 81.1% (95% CI, 68.5-89.3).

    • The vaccine efficacy of Rotarix was 85.0% (95% CI, 69.6-93.5) in reducing hospitalizations for rotavirus gastroenteritis through 1 year. The TVC efficacy was 80.8% (95% CI, 65.7-90.0).

    Efficacy through Two Rotavirus Seasons

    Study 5

    • The vaccine efficacy of Rotarix was the following:

      • 78.9% (95% CI, 72.7-83.8) against any grade of severity of rotavirus gastroenteritis through 2 rotavirus seasons.

      • 71.9% (95% CI, 61.2-79.8) in preventing any grade of severity of rotavirus gastroenteritis cases occurring only during the second season post-vaccination.

      • 90.4% (95% CI, 85.1-94.1) against severe rotavirus gastroenteritis through 2 rotavirus seasons.

      • 85.6% (95% CI, 75.8-91.9) in preventing severe rotavirus gastroenteritis cases occurring only during the second season post-vaccination.

      • 96.0% (95% CI, 83.8-99.5) in reducing hospitalizations for rotavirus gastroenteritis through 2 rotavirus seasons.

    Study 8

    • The vaccine efficacy of Rotarix was the following:

      • 80.5% (95% CI, 71.3-87.1) against severe rotavirus gastroenteritis through 2 rotavirus seasons.

      • 79.0% (95% CI, 66.4-87.4) in preventing severe rotavirus gastroenteritis cases occurring only during the second season post-vaccination.

      • 83.0% (95% CI, 73.1-89.7) in reducing hospitalizations for rotavirus gastroenteritis through 2 rotavirus seasons.

    Efficacy against Specific Rotavirus Types

    • Rotarix achieved statistically significant type-specific efficacy through one year against any grade of severity and severe rotavirus gastroenteritis caused by G1P[8], G3P[8], G4P[8], G9P[8], and combined non-G1 (G2, G3, G4, G9) types. 

    • Rotarix achieved statistically significant type-specific efficacy through 2 years against any grade of severity and severe rotavirus gastroenteritis caused by G1P[8], G2P[4], G3P[8], G4P[8], G9P[8], and combined non-G1 (G2, G3, G4, G9) types.

    Immunogenicity

    Studies 5 and 8

    • In Study 5, 1 to 2 months after a 2-dose series, 86.5% of 787 recipients of Rotarix reconstituted  lyophilized formulation seroconverted vs 6.7% of 420 placebo recipients.

    • In Study 8, 1 to 2 months after a 2-dose series, 76.8% of 393 recipients of ROTARIX reconstituted lyophilized formulation seroconverted compared with 9.7% of 341 placebo recipients, respectively.

    Study 9

    • The study compared seroconversion rates and Geometric Mean Concentraions (GMCs) after administration of Rotarix liquid formulation (n=984) or the Rotarix reconstituted lyophilized formulation (n=329).

    • According to primary analyses, the liquid formulation achieved noninferiority to the reconstituted lyophilized formulation for IgA seroconversion rates and GMCs at 1 to 2 months post-vaccination.

    Study 10

    • This study found that the liquid formulation achieved comparable anti-rotavirus IgA antibodies (concentration ≥20 U/mL) to the reconstituted lyophilized formulation 3 months after a 2-dose series.

    Concomitant Vaccine Administration

    Study 18

    • The US concomitant vaccine administration study found that there was no evidence of interference in the immune responses to any of the antigens when Rotarix was administered with Pediarix, a US-licensed 7-valent pneumococcal conjugate vaccine, and a US-licensed Haemophilus b conjugate vaccine compared with administering Rotarix separately.

    Study 10

    • The concomitant administration of Rotarix liquid formulation was noninferior to Rotarix reconstituted lyophilized formulation when administered with Pediarix, Hiberix, and a US-licensed 13-valent pneumococcal vaccine regarding the immune response to each of the antigens.

    Rotarix Note

    Notes

    Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.

    Rotarix Patient Counseling

    Patient Counseling

    Provide the following information to the parent or guardian: 

    • Inform of the potential benefits and risks of immunization with Rotarix, and of the importance of completing the immunization series. 

    • Inform about the potential for adverse reactions that have been temporally associated with administration of Rotarix or other vaccines containing similar components. 

    • Instruct to immediately report any signs and/or symptoms of intussusception to their healthcare provider. 

    • Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

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