Can you take darunavir while breastfeeding?
What LactMed says
The National Library of Medicine’s own summary, quoted in full. We do not write a verdict of our own on this question, and we do not compress theirs into a label.
Limited information indicates that maternal doses of darunavir up to 800 mg daily with ritonavir produce low to unmeasurable levels in milk and would not be expected to cause any adverse effects in breastfed infants. The combination of darunavir and cobicistat is expected to produce similar results. Achieving and maintaining viral suppression with antiretroviral therapy decreases breastfeeding transmission risk to less than 1%, but not zero. Individuals with HIV who are on antiretroviral therapy with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision. If a viral load is not suppressed, banked pasteurized donor milk or formula is recommended.
Quoted from Darunavir — Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, revised November 15, 2025.
How much darunavir gets into breastmilk
Maternal Levels. Two mothers taking darunavir 800 mg plus ritonavir 100 mg once daily provided 4 milk samples at a median of 15.4 hours after a dose. The median drug concentration in milk was 316 mcg/L, which resulted in an estimated infant dosage of 50 mcg/kg daily and a relative infant dose of 0.12% of the maternal weight-adjusted dosage.
In a retrospective study in a German hospital of mothers who were receiving antiretroviral prophylaxis, one mother was receiving darunavir 800 mg with ritonavir 100 mg once daily. Breastmilk levels obtained at unspecified times with respect to the dose at 1, 4, and 6 months postpartum were all <250 mcg/L.
Infant Levels. An infant was breastfed by a mother taking darunavir 800 mg plus ritonavir 100 mg once daily, although the extent of breastfeeding was not sated. The infant’s serum concentrations taken 16 hours after maternal drug intake at 1 month of age was undetectable.
In a retrospective study in a German hospital, one mother who was receiving darunavir 800 mg with ritonavir 100 mg once daily exclusively breastfed her infant. Infant serum concentrations obtained at unspecified times at 2 weeks and 1, 4 and 6 months of age were all <50 mcg/L.
What has been seen in breastfed infants
Relevant published information was not found as of the revision date.
Effects on milk supply
Gynecomastia has been reported among men receiving highly active antiretroviral therapy. Gynecomastia is unilateral initially, but progresses to bilateral in about half of cases. No alterations in serum prolactin were noted and spontaneous resolution usually occurred within one year, even with continuation of the regimen. Some case reports and in vitro studies have suggested that protease inhibitors might cause hyperprolactinemia and galactorrhea in some male patients, although this has been disputed. The relevance of these findings to nursing mothers is not known. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Frequently asked questions
Can you take darunavir while breastfeeding?
What the NIH's Drugs and Lactation Database says about Darunavir while breastfeeding — quoted in full. The full record is quoted on this page, and the decision is one to make with the person who prescribed it — LactMed itself states it is not a substitute for professional judgement.
Does darunavir pass into breastmilk?
LactMed's measured drug levels for darunavir are quoted in full on this page, under "How much gets into breastmilk".
Do I need to pump and dump after taking darunavir?
LactMed does not frame its records that way — it reports measured drug levels in milk and what has been observed in breastfed infants, which is what this page quotes. "Pump and dump" advice for a specific drug and dose should come from your clinician or a pharmacist, not from a general rule.
More on darunavir
LactMed states that the information it presents is not a substitute for professional judgement, and that you should consult your healthcare provider for breastfeeding advice related to your particular situation. Nothing on this page is medical advice.