Is Nevirapine safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Nevirapine. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
A study assigned pregnant women to zidovudine alone or highly-active antiretroviral therapy (HAART: zidovudine, lamivudine and nevirapine) to prevent maternal-to-child transmission of HIV infection. After delivery, all infants received one month of zidovudine prophylaxis; some infants were breastfed and others were formula fed. A higher percentage of infants in the HAART-exposed group had neutropenia than those in the unexposed group at 1 month of age (15.9 and 3.7%, respectively). Hematologic toxicity was transient and asymptomatic. From 2 to 6 months postpartum, no differences in hematologic toxicity were seen between breastfed and formula-fed infants. No statistical difference in hepatic toxicity was seen between the breastfed and formula-fed infants.[ 28 ] A study compared the frequency of rash, hepatotoxicity, and hyperbilirubinemia among 464 breastfed infants whose mothers were taking either nevirapine (n = 258) or nelfinavir (n = 206) along with zidovudine and lamivudine for HIV infection during pregnancy and postpartum. Infants were examined during the first, second and sixth weeks postpartum. Moderate rash occurred in 7 (2.7%) of the infant exposed to nevirapine and one (0.5%) infant exposed to nelfinavir. Rash occurred at a median of 2 weeks postpartum. Four infants (1.9%) exposed to nelfinavir developed hepatotoxicity (3 moderate and 1 severe) and none exposed to nevirapine. Twenty-one infants (4.5%) developed high-risk hyperbilirubinemia, all prior to 48 hours of age, but there was no difference in exposure between the two drugs.[ 29 ]
Effects on milk supply
Hyperprolactinemia and galactorrhea occurred in a woman on a combination antiretroviral regimen after nevirapine was substituted for nelfinavir. Galactorrhea ceased rapidly after nevirapine was discontinued.[ 30 ] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Levels in milk
Maternal Levels. Four breastmilk samples were obtained from 3 mothers who were taking nevirapine either 100 mg or 200 mg daily. Milk concentrations averaged 76% (range 54 to 104%) of maternal serum concentrations.[ 11 ] Twenty-one women received a single 200 mg oral dose of nevirapine during labor. Milk samples were collected 48, 72 and 168 hours after the dose. Breastmilk concentration of nevirapine were 454 mcg/L (range 219 to 972 mcg/L) at 48 hours postpartum and declined to 103 mcg/L (range 25 to 309 mcg/L) at 7 days postpartum. Milk levels declined in parallel with the maternal serum concentration with a half-life averaging 61 hours.[ 12 ] Three women were receiving nevirapine 200 mg twice daily as part of a highly active antiretroviral combination regimen. During the first 5 days postpartum milk was collected just before and 2 hours after the dose of nevirapine. Breastmilk nevirapine concentrations from milk samples ranged between 68 and 90% of the maternal serum concentration. Further details on the timing, or actual breastmilk concentrations were not provided.[ 13 ] Twenty women who were receiving oral nevirapine 200 mg twice daily as part of a combination antiretroviral regimen had their milk analyzed at either 2 or 5 months postpartum. Milk samples were provided at a median of 4 hours (range 1 to 8.5 hours) after the last dose. The median nevirapine concentration in breastmilk was 6.8 mg/L.[ 14 ] Forty women were given postpartum prophylaxis with unstated dosages of lamivudine, nevirapine and zidovudine (or stavudine if the hemoglobin 8 g/dL). Blood and milk samples were collected once during the first 3 days postpartum and once at 7 days postpartum. The median times after a dose that samples were collected were 5.3 hours (range 0 to 99 hours) for the first sample and 6 hours (range 4.3 to 20 hours) for the 7-day sample. Average breastmilk nevirapine concentrations were calculated only for samples that had detectable ( 50 mcg/L) concentrations of nevirapin
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.