FDA update labels for dolutegravir and dolutegravir-based FDCs to reflect potential risk of neural tube defects

19 September 2018. Related: Antiretrovirals.

Polly Clayden, HIV i-Base

On 6 September 2018, the US FDA approved revisions to the dolutegravir (Tivicay), abacavir/dolutegravir/lamivudine (Triumeq) and dolutegravir/rilpivirine (Juluca) labels to include information on the risk of neural tube defects.

These changes include:

• Pregnancy testing before starting dolutegravir in adolescent and adult women of childbearing potential.
• Advise pregnant adolescents and adults of the potential risk to the embryo exposed to dolutegravir from the time of conception through the first trimester of pregnancy.
• If there are plans to become pregnant or if pregnancy is confirmed within the first trimester while on dolutegravir, if possible, switch to an alternative regimen.
• Advise adolescents and adults of childbearing potential to consistently use effective contraception.
• Register patients who become pregnant to the Antiretroviral Pregnancy Registry (APR).
• Weight gain was also added to the postmarketing experience subsection for each label.

The updated labels are available at drugs@fda, (listed by trade name).

Link

Updated dolutegravir label (Tivicay).
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204790s016s018lbl.pdf (PDF)