[MCOH-EH] Prolia (denosunab) PPE at the time of administration

[Galaid Edward I]

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


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