Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Prolia (denosumab) injection is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe of Prolia contains 60 mg denosumab (60 mg/mL solut...

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Prolia is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass in women at high risk for fracture receiving adjuvant aromat...

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Pregnancy must be ruled out prior to administration of Prolia. Before initiating Prolia in patients with advanced chronic kidney disease, including dialysis patients, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25(OH) 2 vitamin D. ( 2.2 , 5.1 , 8.6 ) Prolia should be administered by a healthcare professional. Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper th...

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Prolia is contraindicated in: Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia . Pregnant women: Prolia may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Prolia . Patients with hypersensitivity to Prolia: Prolia is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. ...

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Same Active Ingredient: Patients receiving Prolia should not receive XGEVA ® . Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs. Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Prolia. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presenc...

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Prolia is contraindicated for use in pregnant women because it may cause harm to a fetus. There are insufficient data with denosumab use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In utero denosumab exposure from cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 50-fold higher than the recommended human dose based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality, and absent lymph nodes,...

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