Is Denosumab Safe in Breastfeeding
Question
I am a breastfeeding mother and i want to know if it is safe to use Denosumab? Is Denosumab safe for nursing mother and child? Does Denosumab extracts into breast milk? Does Denosumab has any long term or short term side effects on infants? Can Denosumab influence milk supply or can Denosumab decrease milk supply in lactating mothers?
Denosumab lactation summary
- DrLact safety Score for Denosumab is 3 out of 8 which is considered Low Risk as per our analyses.
- A safety Score of 3 indicates that usage of Denosumab may cause some minor side effects in breastfed baby.
- Our study of different scientific research indicates that Denosumab may cause moderate to no side effects in lactating mother.
- Most of scientific studies and research papers declaring usage of Denosumab low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
- While using Denosumab We suggest monitoring 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.
Answer by Dr. Ru: About Denosumab usage in lactation
Human-like monoclonal antibody IgG 2 that is used for treatment of severe of Osteoporosis and other disorders characterized by lost of bone mass. At latest update, relevant published information on excretion into breast milk were not found. Because of a high molecular weight, excretion into breast milk in significant amount is highly unlikely. A low oral bioavailability makes absorption from the breast milk into infant's plasma to be seemingly nil or scanty, except for premature infants and in early post-natal period in which an increased absorption may occur.
Answer by DrLact: About Denosumab usage in lactation
No information is available on the clinical use of denosumab during breastfeeding. Because denosumab is a large protein molecule with a molecular weight of about 147,000, 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, denosumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during denosumab therapy. Denosumab is a human immunoglobulin G2 (IgG2) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG2 activity decreasing by about 50%.[3] None of the studies measured IgG activity.
Alternate Drugs
Trastuzumab(Unsafe)
Denosumab(Low Risk)
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Natalizumab(Low Risk)