Is DRG-0004 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use DRG-0004? Is DRG-0004 safe for nursing mother and child? Does DRG-0004 extracts into breast milk? Does DRG-0004 has any long term or short term side effects on infants? Can DRG-0004 influence milk supply or can DRG-0004 decrease milk supply in lactating mothers?

Anti-HIV drug. It is used to decrease the risk of vertical transmission in newborns. 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. DRG-0004 has been well studied during breastfeeding. 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) DRG-0004, lamivudine and efavirenz; 2) DRG-0004, 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] Breastfed infants whose mothers receive a highly active antiretroviral (HAART) regimen containing DRG-0004 have higher rates of neutropenia during the first month and severe anemia during the first 6 months of life.

A study assigned pregnant women to DRG-0004 alone or highly-active antiretroviral therapy (HAART: DRG-0004, lamivudine and nevirapine) to prevent maternal-to-child transmission of HIV infection. After delivery, All infants received one month of DRG-0004 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.[12] A study compared the rates of severe anemia in 3 groups of infants who received postpartum prophylaxis with DRG-0004 for prevention of maternal-to-child transmission of HIV infection. Through 6 months of age, breastfed infants whose mothers received HAART had a higher rate of severe anemia (7.4%) than breastfed infants whose mothers received only DRG-0004 (5.3%). Formula-fed infants had the lowest rate of severe anemia (2.5%). The anemia generally responded well to iron and multivitamin supplementation, and discontinuation of DRG-0004.[13]