Tivicay® (dolutegravir): Reports of Neural Tube Defects

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Description:

There is a potential safety issue related to cases of Neural Tube Defects (NTD) in infants born to women who were treated with antiretroviral regimens containing dolutegravir at the time of conception. Unscheduled preliminary analysis of the Tsepamo Study, carried out in Botswana, revealed four (4) NTD cases out of 426 pregnancies on dolutegravir. However, no NTD cases were detected in infants born to women who started taking dolutegravir during pregnancy (after conception) [N= 0/2824].
While this safety signal is being evaluated further, the following recommendations have been issued:

  • Women of childbearing potential should be informed on the risk of NTD when dolutegravir is used at the time of conception and first month of pregnancy.
  • In women of childbearing potential, pregnancy testing should be performed and pregnancy must be excluded before initiation of treatment.
  • Effective contraception should be used by women of childbearing potential throughout dolutegravir treatment, and pregnancy should be avoided.
  • Dolutegravir should be avoided in women of childbearing potential who wish to become pregnant, unless no alternative treatment is available.
  • If pregnancy is confirmed in the first trimester, it is recommended to switch to an alternative treatment unless no suitable option is available.
  • Dolutegravir should not be used during pregnancy unless the expected benefit justifies the potential risk to the fetus.

A Direct Healthcare Professional Communication (DHPC) letter has been issued by GlaxoSmithKline Pharmaceutical Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to this DHPC for more information.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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  • Last Modified: Thursday 15 November 2018, 11:15:21.
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