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Pregnancy: Data on the use of dolutegravir in pregnant women are limited and its effect on human pregnancy is unknown. In animal studies, dolutegravir crossed the placenta; the studies do not indicate direct or indirect harmful effects.
Dolutegravir should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
Breast-feeding: It is not known if dolutegravir passes into human milk. Animal studies show that dolutegravir appears in milk. In rats receiving a single oral dose of 50 mg/kg 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.
Current recommendations on HIV and breast-feeding (e.g. those from the WHO) should be consulted before advising patients on this matter.
Preferred options may vary depending on the local circumstances.
Fertility: There are no data on dolutegravir's effects on human male or female fertility. Animal studies indicate no effects of dolutegravir on male or female fertility.
