Denosumab (Prolia)

🧮 Dose calculator

Osteoporosis / calcium and vitamin D deficiency · Regimen source: FDA Prolia · 2.3FDA Prolia · 2.1FDA Prolia · 2.2

👥 Special populations

• 🤰 PregnancyContraindicated

  Label: contraindicated in pregnancy. FDA Prolia · 4

  “Pregnant women: Prolia may cause fetal harm when administered to a pregnant woman.”

• 🤱 BreastfeedingUse with caution

  Label: use with caution while breastfeeding; see the label text. FDA Prolia · 8.2

  “Risk Summary There is no information regarding the presence of denosumab in human milk, the effects on the breastfed infant, or the effects on milk production.”

• 👶 ChildrenUse with caution

  The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Prolia · 8.4

  “The safety and effectiveness of Prolia have not been established in pediatric patients.”

• 👴 Older adultsUse with caution

  Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Prolia · 8.5

  “Of the total number of patients in clinical studies of Prolia, 9943 patients (76%) were ≥ 65 years old, while 3576 (27%) were ≥ 75 years old.”

• ⚥ Females & males of reproductive potentialUse with caution

  Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Prolia · 8.3

  “Contraception Females Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Prolia.”