Rotarix

— THERAPEUTIC DISORDERS TREATED —
  • Vaccines

Rotarix Generic Name & Formulations

General Description

Live, attenuated human G1P[8] rotavirus vaccine; lyophilized pwd for oral administration after reconstitution; preservative-free.

How Supplied

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

Manufacturer

Generic Availability

NO

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. 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.

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 (Cat.C): not applicable.

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

See Literature

Rotarix Note

Notes

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

Rotarix Patient Counseling

See Literature