Update to Rotarix prescribing information

GlaxoSmithKline Australia (GSK) has updated the prescribing information (PI) for Rotarix®, its rotavirus vaccine. The update includes new Australian data about the rates of intussusception (IS), a known and rare adverse event.

GlaxoSmithKline Australia (GSK) has updated the prescribing information (PI) for Rotarix®, its rotavirus vaccine. The update includes new Australian data about the rates of intussusception (IS), a known and rare adverse event.

IS occurs in both vaccinated and unvaccinated children. In Australia, the risk of IS without vaccination is 80 cases annually per 100,000.1 The new data suggests that there may be approximately 6 additional annual cases per 100,000 attributable solely to rotavirus vaccination, for a total incidence rate of 86 cases per 100,000 children or 14 additional cases in Australia annually. Whether there is an increase in the overall risk in all children (vaccinated and unvaccinated) is unknown at this stage.2

This new data shows specific occurrence rates of IS around the time of vaccination, with a relative risk of IS in the weeks following rotavirus vaccination of approximately six cases of IS per 100,000 vaccinated infants.2

A summary of the new data is provided on the TGA website.

IS remains rare and the risk of IS being caused by rotavirus vaccination is outweighed by the benefit of vaccination preventing rotavirus infections.2 Before the introduction of the current rotavirus vaccines there were an estimated 10,000 hospitalisations annually in Australian children under 5 years due to rotavirus gastroenteritis (GE).2

Since the introduction of the current rotavirus vaccines on to the National Immunisation Program (NIP) in July 2007 emergency department visits for acute gastroenteritis in young children have declined and hospitalisations for rotavirus gastroenteritis in the under 5 year age group have been reduced by over 70%.3,4

Based on the established benefits of rotavirus vaccination and the rare occurrence of IS, both the World Health Organization (WHO) and the Australian Technical Advisory Group on Immunisation (ATAGI) have recommended the continued use of rotavirus vaccine for infants.2

Patient safety is GSK`s number one priority and we continually review the safety of our medicines and vaccines. The risk of intussusception is rare. Parents should speak to their healthcare professional if their child experiences any side effects following vaccination.

Based on all information currently available, including the significant reduction in infant hospitalisations for rotavirus gastroenteritis, GSK believes the benefit-risk profile of Rotarix remains positive.

1. Immunisation Handbook 2012 (viewed 29 August 2013)
2. TGA Website 2013 (viewed 29 August 2013)
3. Macartney KK, Porwal M, Dalton D, Cripps T et al. Decline in rotavirus hospitalisations following introduction of Australia's national rotavirus immunisation programme. J Paediatr Child Health 2011; 2011;47(5):266-70.
4. Lambert SB, Faux CE, Hall L, Birrell FA et al. Early evidence for direct and indirect effects of the infant rotavirus vaccine program in Queensland. Med J Aust 2009; 191: 157-160.

MINIMUM PI for Rotarix

Human rotavirus (live attenuated oral vaccine) oral liquid

Indications: Prevention of rotavirus gastroenteritis. Contraindications: Hypersensitivity to any components of the vaccine or to a previous rotavirus vaccine; history of chronic gastrointestinal disease, including any uncorrected congenital malformation, such as Meckel’s diverticulum; subjects with a predisposition or history of intussusception, acute severe febrile illness; Severe Combined Immunodeficiency (SCID) disorder. Precautions: Diarrhoea or vomiting, gastrointestinal illnesses; immunodeficiency states (primary and secondary); potential for transmission of excreted vaccine virus to non‐vaccinated contacts; pregnancy (Category B2), lactation. Not intended for use in children older than 24 weeks, adolescents, adults or the elderly. Increased incidence of intussusception (IS) shortly after Doses 1 and 2* (see adverse reactions); whether Rotarix affects overall IS risk has not been established. Advise parents to seek medical attention promptly where IS signs/symptoms evident (severe abdominal pain or distress, persistent vomiting, bloody stools, palpable abdominal mass, abdominal bloating and/or high fever). A protective immune response may not be elicited in all vaccinees. Rotarix does not protect against gastroenteritis due to other pathogens. Rotarix should never be injected. Interactions: Rotarix can be given concomitantly with these vaccines: diphtheria‐tetanus pertussis (DTPa) vaccine, Haemophilus influenzae type b (Hib) vaccine, inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hexavalent vaccine DTPa-HBV-IPV/Hib, pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine. Adverse events: Clinical trials: Irritability, appetite loss, fever, fatigue, vomiting, diarrhoea, flatulence, abdominal pain, cough/runny nose and dermatitis. Post-marketing: Increased risk of IS within 21-31 days (mostly within 7 days) of Dose 1, and some evidence for increased risk within 7 days of Dose 2.* The overall incidence of IS remains rare. Other events reported post-marketing: idiopathic thrombocytopenic purpura, haematochezia, Kawasaki disease; gastroenteritis and viral shedding in infants with SCID. This is not a full list. Dosage and Administration: The vaccination course consists of two 1.5ml doses. The first dose should be 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. Rotarix is for oral use only, and should never be injected. Storage: Store between +2°C and +8°C. DO NOT FREEZE. Store in the original package to protect from light.

For further details, please refer to the Full PI.

* Please note changes in Product Information
PBS Information: This Product is listed on the National Immunisation Program (NIP) Schedule. Refer to NIP Schedule and your State or Territory Health Department for details.
This product is not listed on the PBS

Please review Rotarix product information before prescribing
Full Product Information is available at www.gsk.com.au/rotarix

For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, Vic. Rotarix is a registered trade mark of the GlaxoSmithKline group of companies.