Singapore : Important safety update on dolutegravir (TIVICAY/ TRIUMEQ): Neural tube defects reported in Tsepamo Study, Botswana (English Only)
In Singapore, Health Sciences Authority (HSA) announced that GlaxoSmithKline Pte Ltd, on behalf of ViiV Healthcare, was informing healthcare professionals of a potential safety issue of neural tube defect (NTD) in infants born to women exposed to dolutegravir-containing regimens at the time of conception. This safety concern was identified from a preliminary analysis of the Tsepamo study where 4 NTD cases out of 426 pregnancies on dolutegravir were observed, representing an incidence of 0.9% compared with an expected background rate of 0.1%. This study is ongoing and further data will be captured during the ongoing surveillance. While this safety signal is being evaluated, ViiV Healthcare recommends that pregnancy testing be performed before initiation of treatment in women of child bearing potential (WOCBP). WOCBP who are taking dolutegravir should avoid getting pregnant and to use effective contraception throughout treatment. In WOCBP who are actively seeking to become pregnant, it is recommended to avoid dolutegravir, unless a suitable alternative treatment is not available. If a woman becomes pregnant while taking dolutegravir, it is recommended to switch to an alternative regimen. GlaxoSmithKline Pte Ltd is working with HSA to update the package insert and further information will be communicated as appropriate. 

Please refer to the following website in HSA for details: 

In Hong Kong, there are 2 registered pharmaceutical products containing dolutegravir, namely Tivicay Tablets 50mg (HK-63516) and Triumeq Tablets (HK-64012). Both products are registered by GlaxoSmithKline Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to dolutegravir, but these cases were not related to birth defects. 

Related news was previously issued by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Therapeutic Goods Administration (TGA) and was posted on the Drug Office website on 19 May 2018 and 1 June 2018. Letters to inform local healthcare professionals of the above safety information were issued by the DH on 21 May 2018. The DH will keep vigilant on any further update from the FDA, EMA, TGA, HSA and other health authorities for consideration of any action deemed necessary. 

Ends/Tuesday, June 5, 2018 
Issued at HKT 12:45 

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