Is ONO 4538 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use ONO 4538? Is ONO 4538 safe for nursing mother and child? Does ONO 4538 extracts into breast milk? Does ONO 4538 has any long term or short term side effects on infants? Can ONO 4538 influence milk supply or can ONO 4538 decrease milk supply in lactating mothers?

• DrLact safety Score for ONO 4538 is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of ONO 4538 may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that ONO 4538 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 ONO 4538 .
• It is recommended to evaluate the advantage of not breastfeeding while using ONO 4538 Vs not using ONO 4538 And continue breastfeeding.
• While using ONO 4538 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.

Recombinant immunoglobulin G4 monoclonal antibody which is indicated in certain cases of melanoma. At latest update no published data on excretion into breast milk were found. Its high molecular weight and protein nature make it theoretically impossible any excretion into breastmilk as well as the intestinal absorption by the infant gut: its low oral bioavailability hinders the pass to infant plasma from ingested breastmilk, except in premature and early newborn period, in which there may be an increased intestinal permeability. Although it would be possibly safe during breastfeeding, a long elimination half-life (26,7días) and the likelihood of side effects make prudent to avoid breastfeeding until more published data on this drug is available.The period to “washout" (time-period it takes for the drug to be completely eliminated from the body) that should be expected to resume breastfeeding would be about 134 days (5 half-lives) since the last dose.

No information is available on the clinical use of ONO 4538 during breastfeeding. Because ONO 4538 is a large protein molecule with a molecular weight of 146,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, ONO 4538 should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during ONO 4538 therapy.