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Safety & Tolerability1

The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects.

Most common adverse events for Tivicay:1

The most commonly seen treatment emergent adverse reactions were:1

Nausea (13%)

Diarrhoea (18%)

Headache (13%)

Paediatric Population:1

Based on limited available data in children and adolescents (6 to less than 18 years of age and weighing at least 15 kg), there were no additional types of adverse reactions beyond those observed in the adult population.
 

Contraindications1

Hypersensitivity to the active substance or to any of the excipients
Co-administration with dofetilide
 

Pregnancy:1

Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir. WOCBP who are taking dolutegravir should use effective contraception throughout treatment.

 

For further information on the safety profile on Tivicay please see the Tivicay Summary of Product Characteristics

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Tivicay is registered trademark of the GlaxoSmithKline Group of Companies.