PROLIA Dosage & Rx Info | Uses, Side Effects

Prolia Generic Name & Formulations

Legal Class

General Description

Denosumab 60mg/mL; soln for SC inj; preservative-free.

Pharmacological Class

Osteoclast inhibitor (RANKL inhibitor).

How Supplied

Single-dose prefilled syringe (1mL)—1

Manufacturer

Amgen, Inc.

Generic Availability

Mechanism of Action

Binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts. Prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

Prolia Indications

Indications

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

Adult

Should be administered by a healthcare professional. 60mg SC once every 6mos; inject into upper arm, upper thigh, or abdomen.

Children

Not recommended.

Administration

Give by SC inj in the upper arm, upper thigh or abdomen. For administration from a single-use vial, use a 27-gauge needle to withdraw and inject the dose; do not re-enter the vial.

Nursing Considerations

Give by SC inj in the upper arm, upper thigh or abdomen. For administration from a single-use vial, use a 27-gauge needle to withdraw and inject the dose; do not re-enter the vial. Advise patients of potential fetal exposure when a man treated with denosumab has unprotected sex with a pregnant partner.

Prolia Contraindications

Contraindications

Hypocalcemia. Pregnancy.

Prolia Boxed Warnings

Boxed Warning

Severe hypocalcemia in patients with advanced kidney disease.

Prolia Warnings/Precautions

Warnings/Precautions

Correct hypocalcemia before starting; ensure adequate daily calcium (≥1000mg) and Vit. D (≥400IU) intake in all patients. Monitor calcium, phosphorus, magnesium levels in susceptible patients (eg, hypoparathyroidism, thyroid or parathyroid surgery, malabsorption, excision of small intestine) 10–14 days after administration. Increased risk of severe hypocalcemia in those with advanced chronic kidney disease (eGFR <30mL/min/1.73m²) including dialysis-dependent patients, and markedly increases in the presence of chronic kidney disease-mineral bone disorder (CKD-MBD); evaluate with iPTH, serum calcium, 25(OH) vitamin D, and 1,25(OH)₂ vitamin D prior to Prolia treatment. Consider assessing bone turnover status for underlying bone disease that may be present. Monitor serum calcium weekly for the 1^st month, then monthly thereafter. 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. Advise females of reproductive potential to use effective contraception during and for ≥5mos after last dose; exclude pregnancy status prior to initiation. Nursing mothers.

REMS

YES

Prolia Pharmacokinetics

Absorption

Mean maximum concentration (C_max): 6.75 mcg/mL. Median time to maximum concentration (T_max): 10 days (range: 3–21 days).

Elimination

Half-life: 25.4 days.

Prolia Interactions

Interactions

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

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

See Literature

Prolia Note

Not Applicable

Prolia Patient Counseling