Prolia Generic Name & Formulations
Denosumab 60mg/mL; soln for SC inj; preservative-free.
Osteoclast inhibitor (RANKL inhibitor).
Single-dose prefilled syringe (1mL)—1
In postmenopausal women with osteoporosis: at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other therapy; to reduce incidence of vertebral, nonvertebral, and hip fractures. To increase bone mass in men with osteoporosis 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 reduce incidence of vertebral fractures. To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. To treat glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids equivalent to ≥7.5mg/day of prednisone and expected to continue for ≥6mos.
Prolia Dosage and Administration
Should be administered by a healthcare professional. 60mg SC once every 6mos; inject into upper arm, upper thigh, or abdomen.
Prolia Boxed Warnings
Correct hypocalcemia before starting; ensure adequate daily calcium (≥1000mg) and Vit. D (≥400IU) intake, esp. in renal impairment (CrCl<30mL/min). Monitor calcium, phosphorus, magnesium levels in susceptible patients (eg, hypoparathyroidism, thyroid or parathyroid surgery, malabsorption, excision of small intestine, severe renal impairment, on dialysis) within 14 days of treatment. Monitor for infections, osteonecrosis of the jaw (ONJ), bone oversuppression. Do baseline oral exam and preventive dentistry if risks for ONJ exist (eg, tooth extraction, dental implants, oral surgery, poor oral hygiene, periodontal disease and/or other pre-existing dental disease, ill-fitting dentures, cancer, anemia, coagulopathy, infection). Maintain good oral hygiene. Consider discontinuing if severe skin reactions or musculoskeletal pain develop. Evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Increased risk of multiple vertebral fractures after treatment discontinuation; transition to alternative therapy if discontinued. Immunosuppressed. Latex allergy. Advise females of reproductive potential to use effective contraception during and for ≥5mos after last dose; exclude pregnancy status prior to initiation. Nursing mothers.
Concomitant other denosumab-containing products (eg, Xgeva): not recommended. Concomitant immunosuppressants (increased infection risk). Increased risk of ONJ with concomitant corticosteroids, chemotherapy, angiogenesis inhibitors or duration of denosumab exposure. Concomitant calcimimetic drugs may worsen hypocalcemia risk; monitor serum calcium.
Prolia Adverse Reactions
Pain (back, extremities or musculoskeletal), arthralgia, nasopharyngitis, hypercholesterolemia, cystitis, pancreatitis, hypertension, bronchitis, headache; infections (may be serious), dermatitis, rash, eczema, ONJ, atypical femur fractures, suppression of bone turnover, exacerbation of hypocalcemia, anaphylactic reactions (discontinue if occurs), hypercalcemia (in pediatric patients with osteogenesis imperfecta).
Prolia Clinical Trials
Prolia Patient Counseling