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

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).


Updated dolutegravir label (Tivicay). (PDF)

Links to other websites are current at date of posting but not maintained.