Generic Name and Formulations:
Denosumab 60mg/mL; soln for SC injection; preservative-free.

Company:
Amgen, Inc.

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.

Adult Dose for PROLIA:
Should be administered by a healthcare professional. 60mg SC once every 6 months; inject into upper arm, upper thigh, or abdomen.

Children's Dose for PROLIA:
Not established.

Pharmacological Class:
Osteoclast inhibitor (RANKL inhibitor).

Contraindications:
Hypocalcemia. Pregnancy (Cat.X).

Warnings/Precautions:
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 (hypoparathyroidism, thyroid or parathyroid surgery, malabsorption, excision of small intestine, severe renal impairment, on dialysis). Monitor for infections, jaw osteonecrosis, bone oversuppression. Do baseline oral exam and preventive dentistry if risks for jaw osteonecrosis 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. eva luate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Immunosuppressed. Latex allergy (prefilled syringe). Nursing mothers: avoid (may impair mammary glands/lactation).

Interactions:
Concomitant other denosumab-containing products (eg, Xgeva): not recommended. Concomitant immunosuppressants (increased infection risk). Corticosteroids, chemotherapy (increased jaw osteonecrosis risk).

Adverse Reactions:
Pain (back, lower extremities or musculoskeletal), arthralgia, hypercholesterolemia, cystitis; infections (may be serious; eg, cellulitis, UTI, otic, abdominal), dermatitis, rash, eczema, osteonecrosis of jaw, atypical femur fractures, suppression of bone turnover, exacerbation of hypocalcemia, pancreatitis.

Generic Availability:
NO

How Supplied:
Single-use vial (1mL)—1; Single-dose prefilled syr (1mL)—1