Prolia

Prolia

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Denosumab
Indications/Uses
Osteoporosis in postmenopausal women & in men at increased risk of fractures. Increases bone mineral density & reduces incidence of hip, vertebral & non-vertebral fractures in postmenopausal women w/ osteoporosis. Bone loss in patients undergoing hormone ablation for prostate or breast cancer at increased risk of fractures. Bone loss associated w/ long-term systemic glucocorticoid therapy in adults at increased risk of fracture.
Dosage/Direction for Use
Contraindications
History of hypersensitivity. Hypocalcaemia.
Special Precautions
Do not take w/ Xgeva. Consider temporary interruption of treatment in patients who develop osteonecrosis of jaw (ONJ). Skin infections (predominantly cellulitis); atypical femoral fractures; ONJ in patients w/ advanced cancer receiving 120 mg every 4 wk, poor oral hygiene & invasive dental procedures (eg, tooth extraction). Multiple vertebral fractures in patients w/ history of vertebral fracture. Adequate intake of Ca & vit D. Correct hypocalcemia & evaluate for risk factors for ONJ before initiating therapy. Monitor Ca levels in patients predisposed to hypocalcaemia during treatment & 1st few wk of initiating therapy. Perform dental exam w/ appropriate preventive dentistry prior to treatment if risk factors are identified. Maintain good oral hygiene practices & avoid invasive dental procedures during treatment. Evaluate for incomplete femoral fracture & examine contralateral femur in patients w/ new or unusual thigh, hip or groin pain during treatment. Consider transitioning to alternative antiresorptive therapy upon discontinuation of treatment. Severe renal impairment (CrCl <30 mL/min) or receiving dialysis. Hepatic impairment. Not recommended for use in pregnant women. Lactation. Not indicated for use in paed patients.
Adverse Reactions
Pain in extremity, musculoskeletal pain. Eczema; alopecia. DRESS.
Drug Interactions
Increased risk of serious infections w/ immunosuppressive agents.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Presentation/Packing
Form
Prolia soln for inj 60 mg/mL
Packing/Price
1's
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