Is Raltegravir safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Raltegravir. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. A woman infected with HIV was receiving raltegravir 800 mg, emtricitabine 200 mg and tenofovir disoproxil 245 mg once daily. She exclusively breastfed her infant for 4 months, then partially until 9 months postpartum. Breastmilk samples were taken over 12- to 24-hour periods at 4 and 8 months postpartum. At 4 months postpartum, the average milk concentration over 12 hours was 0.66 mg/L with an estimated daily infant dose of 0.099 mg/kg or 0.8% of the approved daily raltegravir dosage for infants. At 8 months postpartum, a peak milk level of about 6 mg/L occurred at about 6 hours after the dose. The level fell to about 0.3 mg/L at 24 hours after the dose.[ 3 ] Milk samples were obtained from 10 mothers taking raltegravir either 400 mg twice daily or 1200 mg once daily. Three milk samples were obtained from others taking 400 mg twice daily at a median of 3.6 hours after a dose. The median drug concentration in milk was 1635 mcg/L, which resulted in an estimated infant dosage of 0.25 mg/kg daily and a relative infant dose of 4.1% of the maternal weight-adjusted dosage. Mothers taking raltegravir 1200 mg once daily provided 14 milk samples at a median of 13.7 hours after a dose. The median drug concentration in milk was 111 mcg/L, which resulted in an estimated infant dosage of 20 mcg/kg daily and a relative infant dose of 0.28% of the maternal weight-adjusted dosage.[ 4 ] In a retrospective study in a German hospital of mothers who were receiving antiretroviral prophylaxis, one mother was receiving raltegravir 400 mg twice daily. Breastmilk levels obtained at unspecified times with respect to the dose were 1757 mcg/L at 14 days postpartum, 293 mcg/L at 1 month postpartum and 168 mcg/L at 4 months postpartum.[ 5 ] Infant Levels. A woman infected with HIV was receiving raltegravir 800 mg, emtricitabine 200 mg and tenofovir disoproxil 245 mg once daily. She exclusively breastfed her infant for 4 months, then partially until 9 months postpartum. Single blo
Alternatives LactMed lists
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.