Rotarix Special Precautions

It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
As with other vaccines, administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses. Administration of Rotarix may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
The risk of intussusception has been evaluated in a large safety trial (including 63,225 infants) conducted in Latin America and Finland. No increased risk of intussusception was observed in this clinical trial following administration of Rotarix when compared with placebo.
However, post-marketing safety studies indicate a transient increased incidence of intussusception after vaccination mostly within 7 days of the first dose and, to a lesser extent, the second dose. The overall incidence of intussusception remains rare. Whether Rotarix affects the overall risk of intussusception has not been established.
As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever). Parents/guardians should be advised to promptly report such symptoms.
For subjects with a predisposition for intussusception, see Contraindications.
Administration of Rotarix in immunosuppressed infants, including infants on immunosuppressive therapy, should be based on careful consideration of potential benefits and risks (see Pharmacology: Pharmacodynamics under Actions).
Excretion of the vaccine virus in the stools is known to occur after vaccination and lasts for 10 days on average with peak excretion around the 7th day (see Pharmacology: Pharmacodynamics under Actions). In clinical trials, cases of transmission of excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptoms. Rotarix should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or receiving immunosuppressive therapy. Contacts of recent vaccinees should be advised to observe careful hygiene (including washing their hands) when changing children's nappies.
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see Pharmacology: Pharmacodynamics under Actions).
The extent of protection that Rotarix might provide against rotavirus strains that have not been circulating in clinical trials is currently unknown (see Pharmacology: Pharmacodynamics under Actions).
Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus.
ROTARIX SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.
Effects on Ability to Drive and Use Machines: Rotarix is not intended for use in adults.