My CMO just asked me about changes in PPE required to be worn when administering  Prolia. Has anyone heard anything about this?

 

For those who are interested, here’s the tox profile off of the mfr’s SDS:

 

Acute Toxicity: No information available

Skin corrosion/irritation: No information available

Serious eye damage/eye irritation: No information available

Respiratory or skin sensitization: No information available

Germ cell mutagenicity: No information available

Carcinogenicity: No information available

Reproductive toxicity: Even though this does not meet GHS classification, the following data is available: ProliaÒ exposure in cynomolgus monkeys by subcutaneous injection at 50 mg/kg from gestation day 20 to parturition resulted in increased fetal loss, stillbirths, and postnatal mortality, along with histological changes in infants. In general, the effects observed in mothers and infants were consistent with the pharmacological action of denosumab as a monoclonal antibody against RANKL and an inhibitor of osteoclastic bone resorption. No effects on male or female fertility have been observed.  

STOT - single exposure: No information available

STOT - repeated exposure: Even though this does not meet GHS classification, the following data is available: ProliaÒ was administered to cynomolgus monkeys via subcutaneous injection once monthly for 1 year at doses of 1, 10 and 50 mg/kg and no adverse effects were observed. Denosumab produced rapid and sustained decreases in markers of bone turnover and increases in bone mineral density at doses >1 mg/kg, which were attributable to the pharmacologic activity of the monoclonal antibody.

Aspiration Hazard: No information available

 

Thanks

 

Ed Galaid

 

Edward I. Galaid, MD, MPH, FACOEM

ABIM, ABPM (OM)

Medical Director, Occupational Medicine

Roper Saint Francis Healthcare

Charleston, SC 29401

Member, ACOEM Task Group on Law Enforcement Officer Health

843-402-5053