Is AG-1343 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use AG-1343? Is AG-1343 safe for nursing mother and child? Does AG-1343 extracts into breast milk? Does AG-1343 has any long term or short term side effects on infants? Can AG-1343 influence milk supply or can AG-1343 decrease milk supply in lactating mothers?

• DrLact safety Score for AG-1343 is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of AG-1343 may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that AG-1343 may cause moderate to high side effects or may affect milk supply in lactating mother.
• Our suggestion is to use safer alternate options rather than using AG-1343 .
• It is recommended to evaluate the advantage of not breastfeeding while using AG-1343 Vs not using AG-1343 And continue breastfeeding.
• While using AG-1343 Its must to monitor child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
• Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Anti-HIV drug. There is not experience on children younger than 2 years old. Mothers must be adviced that transmission of HIV infection through breastfeeding has been documented.

In the United States and other developed countries, HIV-infected mothers should generally not breastfeed their infants. Published experience with AG-1343 during breastfeeding is limited. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, World Health Organization guidelines recommend that all women with an HIV infection who are pregnant or breastfeeding should be maintained on antiretroviral therapy for at least the duration of risk for mother-to-child transmission. Mothers should exclusively breastfeed their infants for the first 6 months of life; breastfeeding with complementary feeding should continue through at least 12 months of life up to 24 months of life.[1] The first choice regimen for nursing mothers is tenofovir, efavirenz and either lamivudine or emtricitabine. If these drugs are unavailable, alternative regimens include: 1) zidovudine, lamivudine and efavirenz; 2) zidovudine, lamivudine and nevirapine; or 3) tenofovir, nevirapine and either lamivudine or emtricitabine. Exclusively breastfed infants should also receive 6 weeks of prophylaxis with nevirapine.[2][3]

A study compared the frequency of rash, hepatotoxicity, and hyperbilirubinemia among 464 breastfed infants whose mothers were taking either AG-1343 (n = 206) or nevirapine (n = 258) 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 AG-1343. Rash occurred at a median of 2 weeks postpartum. Four infants (1.9%) exposed to AG-1343 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.[8]

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.[9][10][11] Some case reports and in vitro studies have suggested that protease inhibitors might cause hyperprolactinemia and galactorrhea in some male patients,[12][13] although this has been disputed.[14] 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.