• PROLIA® is administered as a 60mg subcutaneous injection every 6 months.
• Approved injection sites: Upper arm, upper thigh, or abdomen.
• Mandatory supplementation: Calcium 1,000mg/day and vitamin D 400 IU/day throughout treatment.
• Pre-treatment: Correct hypocalcemia before initiating therapy.
• REMS program: inform patients with advanced chronic kidney disease or those on dialysis of the severe hypocalcemia risk per the current boxed warning.
• Key warnings:
  • Osteonecrosis of the jaw,
  • Atypical femoral fractures
  • Severe musculoskeletal pain,
  • Pregnancy contraindication.
• Discontinuation Warning: Stopping or delaying PROLIA® causes rapid rebound in bone turnover that can spike above baseline and substantially increase the risk of multiple vertebral fractures. If discontinuation is necessary, transition the patient to another antiresorptive therapy, such as a bisphosphonate, without delay.

PROLIA® is used as an osteoporosis treatment in selected high-risk patient groups. It is:

• Indicated for postmenopausal women with osteoporosis at high risk for fracture.
• Prescribed to treat men with osteoporosis at high risk for fracture.
• Indicated for glucocorticoid-induced osteoporosis in men and women at high risk for fracture who are initiating or continuing systemic glucocorticoids at a daily dosage equivalent to prednisone 7.5mg or greater and expected to remain on glucocorticoids for at least 6 months.
• Prescribed to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
• Prescribed to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Product Specs

• Active ingredient: denosumab 60mg/ml
• Format: single-use pre-filled syringe, 1ml, preservative-free
• Manufacturer: Amgen

Contraindications

• Hypocalcemia
• Hypersensitivity to denosumab or any excipient
• Pregnancy

• Subcutaneous injection only – do not inject IV or IM
• Administer in the upper arm, upper thigh, or abdomen by an appropriately trained healthcare professional
• Single-use – discard the syringe after use
• Allow to reach room temperature before injection by removing from the refrigerator approximately 30 minutes prior; do not warm by any other means; once removed from refrigeration, use within 14 days at a temperature not exceeding 25°C
• Administer calcium 1,000mg/day and vitamin D 400 IU/day before the first injection and throughout treatment
• Monitor serum calcium throughout therapy, especially in renally impaired patients – severe hypocalcemia most commonly emerges between 2 and 10 weeks after injection; in patients with advanced chronic kidney disease, evaluate for CKD-mineral and bone disorder before initiating treatment, given the current boxed warning
• Treatment continuity is critical: stopping or delaying PROLIA® triggers rapid bone turnover rebound and substantially increases the risk of multiple vertebral fractures; transition to another antiresorptive agent promptly if discontinuation is planned or unavoidable.