Vascular endothelial growth factor-A and drug level in serum and human breast milk of a lactating woman after intravitreal injection of ranibizumab: a case report.

Background: Evidence on the excretion of anti-VEGF drugs in human breast milk was very limited. Here we investigated the level of VEGF-A protein and free drug concentration of ranibizumab in serum and breast milk following intravitreal injection of ranibizumab in a young woman suffering from branch retinal vein occlusion (BRVO). Case presentation: A 30-year-old female, who was nursing her six-month-old son, was treated by intravitreal injection of ranibizumab (IVR) for cystoid macular edema owing to BRVO of her right eye. Serum and breast milk samples were collected before and within 4 weeks after injection. Levels of VEGF-A and free ranibizumab were evaluated in all the samples by the enzyme-linked immunosorbent assay (ELISA). Ranibizumab concentration in both serum and breast milk increased rapidly on day one, with ranibizumab level in serum peaked at 15.35 ng/mL and ranibizumab level in breast milk peaked at 3.14 ng/mL. The VEGF-A protein remained a very low level in serum, while decreased over the first three days from 29.49 ng/mL to 12.75 ng/mL, then slowly increased to almost pre-injection level in breast milk. Conclusion: Systemic exposure to ranibizumab was observable following intravitreal injection in a breastfeeding patient. While serum levels of VEGF-A remained stable following ranibizumab administration, the functional alterations resulting from variations in VEGF-A in breast milk and the implications for breastfeeding infants were ambiguous. When lactating women experience specific sight-threatening conditions, additional evaluations are required to ascertain the safety profile of anti-VEGF therapy for nursing infants.