DENOSUMAB-BMWO

RANKL Inhibitor

Brand names: Stoboclo

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Denosumab products bind to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab products prevent 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.

Indications

defined as a history of osteoporotic fracture

or multiple risk factors for fracture

or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis

denosumab reduces the incidence of vertebral

nonvertebral

defined as a history of osteoporotic fracture

Contraindications

• facial swelling
• and urticaria [see Warnings and Precautions (5.3)
• Adverse Reactions (6.2) ] . Hypocalcemia ( 4
• 5.1 ) Pregnancy ( 4
• 8.1 ) Known hypersensitivity to denosumab products ( 4

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Stoboclo
Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk
6 ) Serious infections including skin infections: May occur, including those leading to hospitalization
1 Severe Hypocalcemia and Mineral Metabolism Changes Denosumab products can cause severe hypocalcemia and fatal cases have been reported

Known Side Effects

1 documented side effects by frequency

Diarrhea

>10%

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Compare With

3 available comparisons

Formulations

Dosage Forms

Tablet

Route

Subcutaneous