ROTARIX

What it is

ROTARIX is a liquid suspension of the live attenuated RIX4414 strain of human rotavirus of the G1P[8] type for use in the prevention of rotavirus gastroenteritis. ROTARIX is presented as a clear, colourless liquid, free of visible particles, for oral administration only. Each 1.5 mL dose of the vaccine contains not less than 10^6.0 CCID50 (cell culture infectious dose 50%) of the RIX4414 strain of human rotavirus.

Approved indications

— Prevention of rotavirus gastroenteritis.

Dosing overview

The vaccination course consists of two doses, with the first dose given between 6 and 14 weeks of age. The interval between the two doses should not be less than 4 weeks. The vaccine course should be completed by the age of 24 weeks as safety has not been assessed in older children. In the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.

Key safety warnings

Safety has not been assessed in children older than 24 weeks of age. The manufacture of this product includes exposure to bovine derived materials at the very early steps of the production process, though no bovine materials are used in routine production. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. Excipients of known effect include phenylalanine and sucrose.

Regulatory history

ROTARIX was first listed on the Australian Register of Therapeutic Goods (ARTG 146776) on 27 August 2008. A tube formulation (ARTG 326141) was subsequently listed on 19 February 2020.