live attenuated rotavirus vaccine: clinical use

Prescribing considerations

• Review medical history, current illness, immune status, maternal biological therapy and the newborn SCID screening result before administration.
• Postpone during acute severe febrile illness, diarrhoea or vomiting; a minor infection alone is not a contraindication.
• Use particular caution in suspected immunodeficiencies and seek input from the clinician managing the underlying condition.
• Consider respiratory monitoring after vaccination in very premature infants, particularly with respiratory immaturity.
• Counsel carers about vaccine-virus shedding and hand hygiene after nappy changes.

Contraindications and cautions

• Hypersensitivity to the vaccine, an excipient or a previous rotavirus vaccination
• Previous intussusception
• Uncorrected gastrointestinal malformation that predisposes to intussusception
• Severe combined immunodeficiency
• Rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
• Relevant maternal exposure to immunomodulating biological therapy, according to current UK immunisation guidance

Monitoring

• Ensure treatment for anaphylaxis is immediately available.
• Advise carers to seek prompt assessment for symptoms suggestive of intussusception, especially soon after vaccination.
• Record product name and batch number.
• Consider post-vaccination respiratory observation in very premature infants at risk of apnoea.

Clinical pharmacology

A live attenuated human rotavirus RIX4414 vaccine administered orally. It induces protective immunity against rotavirus gastroenteritis; conventional pharmacokinetic assessment is not applicable.

Formulation and product differences

• Clear, colourless, ready-to-use oral suspension in a squeezable tube.
• No reconstitution or dilution is required; do not mix with other medicines or solutions.
• Contains sucrose, sodium, glucose and phenylalanine-containing culture medium components.
• Store refrigerated, protect from light and do not freeze; use immediately after opening.