Generic Name and Formulations:
Denosumab 60mg/mL; soln for SC inj; preservative-free.
Indications for PROLIA:
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.
Should be administered by a healthcare professional. 60mg SC once every 6 months; inject into upper arm, upper thigh, or abdomen.
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). 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. Risk of multiple vertebral fractures after treatment discontinuation; consider transitioning to alternative therapy. Immunosuppressed. Latex allergy (pre-filled syringe). Nursing mothers: not recommended (may impair mammary glands/lactation).
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.
Osteoclast inhibitor (RANKL inhibitor).
Pain (back, lower extremities or musculoskeletal), arthralgia, nasopharyngitis, hypercholesterolemia, cystitis; infections (may be serious; eg, cellulitis, UTI, otic, abdominal), dermatitis, rash, eczema, ONJ, atypical femur fractures, suppression of bone turnover, exacerbation of hypocalcemia, pancreatitis, anaphylactic reactions (discontinue if occurs).
Single-use vial (1mL)—1; Single-dose pre-filled syringe (1mL)—1