Product: Rotarix
Company: GlaxoSmithKline
Pharmacologic class: Vaccine
Active ingredient: Live, attenuated human G1P[8] rotavirus vaccine; lyophilized powder for oral administration
after reconstitution; preservative-free.
Indication: Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9)
in infants and children.
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Pharmacology: Before rotavirus immunization programs were put into effect, most children became in-fected with this virus before age 5 years. Severe, dehydrating rotavirus gastroenteritis occurred in young children, mostly in those who were 3-35 months old; about 20% of cases before age 6 months resulted in hospitalization. Rotarix contains a live, attenuated rotavirus that replicates in the small intestine and induces immunity.
Clinical trials: The efficacy of Rotarix in preventing rotavirus gastroenteritis was demonstrated in two clinical studies conducted in Europe and Latin America involving more than 24,000 infants. In these studies, oral polio vaccine was not administered concurrently, although other childhood vaccines could be co-administered. A randomized, double-blind, placebo-controlled clinical trial involving 3,994 infants was conducted in Europe. Either Rotarix or placebo was administered to healthy infants as a two-dose series. The primary efficacy end point was the prevention of any grade of rotavirus gastroenteritis caused by natural rotavirus from two weeks after the second dose through one rotavirus season. The efficacy of Rotarix against gastroenteritis of any severity through one rotavirus season was 87.1%, while the efficacy against severe gastroenteritis was 95.8%. The protective effect of Rotarix against gastroenteritis of any severity observed in the time period immediately following the first dose and before the second dose was 89.8%. The efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through one rotavirus season was 100%.
Adults: Not applicable.
Children: <6 weeks or >24 weeks of age: not recommended. Each oral dose is 1 mL. Give first dose beginning at six weeks of age, second dose at least four weeks later; complete two-dose series by 24th week of age. May give a replacement dose at same vaccination visit if dosing is incomplete or regurgitated.
Contraindications: Uncorrected congenital GI tract malformation (e.g., Meckel’s diverticulum) (increased risk of intussusception).
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. regnancy (Cat. C): not applicable.
Interactions: May give with concomitant vaccines (e.g., diphtheria, tetanus, and acellular pertussis; hepatitis B; inactivated polio-virus vaccine combined; Hemophilus influenzae type b conjugate). Immunosuppressants (e.g., irradiation, chemotherapy, high-dose steroids): may get suboptimal response.
Adverse reactions: Fussiness/irritability, cough/runny nose, fever, loss of appetite, vomiting, diarrhea, dehydration, pneumonia; rare: Kawasaki disease.
Note: Report adverse events to VAERS at 800.822.7967 and to GlaxoSmithKline at 888.825.5249.
How supplied: Vials—10 (with prefilled diluent in oral applicator)
For more information, call 888.825.5249 or visit www.Rotarix.com.
