St. Michael’s Hospital Researchers Reveal Ranibizumab & Aflibercept May Pose Risk to Infants Via Breast Milk

Sep 15, 2019 | Opthomology, Retina

St. Michael’s Hospital Researchers Reveal Ranibizumab & Aflibercept May Pose Risk to Infants Via Breast Milk

St. Michael’s Hospital’s Li Ka Shing Knowledge Institute conducted a first-of-its-kind study and has uncovered that ranibizumab and aflibercept, medications used to treat retinal diseases, may put developing infants at risk as the drugs are excreted into breast milk.

What are Ranibizumab and Aflibercept?

Ranibizumab and Aflibercept are drugs used to treat multiple retinal diseases. They contain an agent called anti-vascular endothelial growth factor (anti-VEGF), which blocks the eye’s production of VEGF. A protein that simulates the development of blood vessels, VEGF is associated with retinal diseases in high quantities.

Ranibizumab (Lucentis) was developed by Genentech (Roche) and marketed by them in the United States and elsewhere by Novartis (Lucentis). Aflibercept, invented by Regeneron Pharmaceuticals, is sold under the name Eylea and Zaltrap. It is being co-developed for cancer treatment by Sanofi and Regeneron and with Bayer for eye diseases.

The Issue with VEGF

Present in breast milk, it plays and important role in the development of an infant’s digestive system. As a result, anti-VEGF drugs in a nursing mother raise concerns about possible adverse events in a developing infant if the drugs were to pass into breast milk and suppress VEGF.

The Study

Investigators from St. Michaels measured concentrations of retinal medications in the breast mil of three lactating patients following injection of anti-VEGF therapy. Each patient represented a different scenario—one continued to breastfeed while receiving therapy; one discontinued breastfeeding and one never started.

The Results:

The team found that the drugs were excreted into the breast milk within the first couple days following injection, with a corresponding reduction in VEGF levels. They also found that the amount of medication dedicated in the patient who continued to breastfeed was much lower than the other two patients, suggesting that the medication was constantly excreted and ingested by the infant.

Co-investigator Dr. Juncal noted “These results definitely show us that the drug reaches the breast milk.”

A First Look

This is the first study to evaluate the presence of Health Canada approved anti-VEGF therapy in human breast milk, and these results offer a resource for ophthalmologists and retina specialists counseling pregnant and nursing patients.

About St. Michael’s Hospital Li Ka Shing Knowledge Institute

The hospital is home to the Li Ka Shing Knowledge institute, with a state-of-the-art research center. The center aims to bring together the areas of research and education to advance patient care.

The Institute 

Lead Research/Investigator

Dr. Rajeev Muni, co-lead author


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