FDA update labels for dolutegravir and dolutegravir-based FDCs to reflect potential risk of neural tube defects
19 September 2018. Related: Antiretrovirals.
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).