Prolia (Denosumab) Pre-Filled Syringe 60mg/ml

Bone-Modifying Agent; Monoclonal Antibody

CSA NA – FDA Approved – REMS (Y) – Cannot Ship To US

Denosumab is a monoclonal antibody with affinity for nuclear factor-kappa ligand (RANKL). Osteoblasts secrete RANKL; RANKL activates osteoclast precursors and subsequent osteolysis which promotes release of bone-derived growth factors, such as insulin-like growth factor-1 (IGF1) and transforming growth factor-beta (TGF-beta) and increases serum calcium levels. Denosumab binds to RANKL, blocks the interaction between RANKL and RANK (a receptor located on osteoclast surfaces), and prevents osteoclast formation, leading to decreased bone resorption and increased bone mass in osteoporosis. In solid tumors with bony metastases, RANKL inhibition decreases osteoclastic activity leading to decreased skeletal related events and tumor-induced bone destruction. In giant cell tumors of the bone (which express RANK and RANKL), denosumab inhibits tumor growth by preventing RANKL from activating its receptor (RANK) on the osteoclast surface, osteoclast precursors, and osteoclast-like giant cells.

Prolia – Osteoporosis/bone loss

Xgeva – Multiple myeloma, hypercalcemia of malignancy, giant cell tumor of bone, bone metastasis from solid tumors

Before starting Denosumab, Prolia/Xgeva make sure your physician is aware of any allergies or medications you currently take, if you have preexisting hypocalcemia, kidney disease, are pregnant, or breastfeeding.  Denosumab, Prolia/Xgeva use has been associated with rare but serious reactions including atypical bone fracture, dermatological reactions, hypersensitivity, hypercalcemia, hypocalcemia, increased infection risk, osteonecrosis of the jaw, and musculoskeletal pain.

Xgeva: Subcutaneous: 120 mg every 4 weeks – some conditions have additional dosages

Prolia: Subcutaneous: 60 mg as a single dose, once every 6 months

How to Take: Prior to administration, bring to room temperature in original container (allow to stand ~15 to 30 minutes). Solution may contain trace amounts of translucent to white protein particles. Administer via subcutaneous injection in the upper arm, upper thigh, or abdomen; should only be administered by a health care professional. Ensure adequate calcium and vitamin D intake to prevent or treat hypocalcemia. Calcium 1,000 mg/day and vitamin D ≥400 units/day is recommended in product labeling (Prolia). Store in original carton at 2°C to 8°C (36°F to 46°F). Use within 14 days once at room temperature. 

You Need to Avoid:  Denosumab is intended for subcutaneous route only and should not be administered IV, IM, or intradermally. Do not warm by any other method other than letting stand at room temperature.  Do not use if cloudy, discolored (normal solution should be clear and colorless to pale yellow), or contains excessive particles or foreign matter. Avoid vigorous shaking of product. Protect from direct heat and light; do not expose to temperatures >25°C (77°F). Do not freeze.

Peripheral edema, dermatitis, eczema, hypocalcemia, hypophosphatemia, diarrhea, nausea, anemia, thrombocytopenia, fatigue, headache, arthralgia, asthenia (weakness), back pain, limb pain, dyspnea (difficulty breathing), cough, upper respiratory tract infection

Note this is not a complete list of side effects, but the most common ones.  Prolia is dosed far less frequently and at a lower dosage and therefore has lower rates of side effects.