Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception
New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.
Advice for healthcare professionals:
- do not prescribe dolutegravir to women who are trying to become pregnant
- exclude pregnancy in women of childbearing potential with pregnancy testing before starting dolutegravir
- advise women of childbearing potential to use effective contraception throughout treatment with dolutegravir
- if pregnancy is confirmed in the first trimester while a woman is taking dolutegravir, switch to an alternative treatment unless there is no suitable alternative
- advise any women taking dolutegravir for HIV to not stop taking their medicine without first consulting their doctor
- report any suspected adverse drug reactions associated with dolutegravir to the Yellow Card Scheme
Signal of increased risk of neural tube defects
An EU review has begun following preliminary results from an observational study suggesting an increased risk of neural tube defects in infants born to women who took dolutegravir at the time of conception.
The study, which looked at babies born to 11,558 women with HIV in Botswana, showed that 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a neural tube defect, compared with 0.1% of babies (14 of 11,173) whose mothers took other HIV medicines. No cases were reported in infants born to women who started dolutegravir later during pregnancy. Final results of the study are expected in about a year. The review will also investigate cases of birth defects in babies born to women who took dolutegravir during pregnancy reported, including two in the USA
A has been sent to healthcare professionals involved in the care of patients with HIV and to patient groups in the UK to advise of these recommendations. The European Medicines Agency has issued information to patients.
Further advice will be communicated as appropriate at the end of the review.
Background
▼Dolutegravir is an integrase inhibitor indicated in combination with other anti-retroviral medicinal products for the treatment of HIV in adults, adolescents, and children older than 6 years. In the EU, dolutegravir has been authorised since 2014. It is marketed on its own as Tivicay and in combination with lamivudine and abacavir as Triumeq or in combination with rilpivirine hydrochloride as Juluca. Further information on these medicines can be found on the EMA website or in the Summaries of Product Characteristics.
Report any suspected adverse drug reactions
Any suspected adverse drug reactions with dolutegravir (Tivicay▼, Triumeq▼, Juluca▼) should be reported without delay on a Yellow Card.
Reporting of suspected side effects in the mother or baby following medicine use in pregnancy is vital for the safe use of medicines. It is quick and easy to report online or via the Yellow Card app (download from the Apple App Store, or Google Play Store).
Further information
EMA press release. New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir. 18 May 2018.
. 23 May 2018.
Article citation: Drug Safety Update volume 11 issue 10; June 2018: 1.