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Prolia

Prolia

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig
Concise Prescribing Info
Contents
Denosumab
Indications/Uses
Postmenopausal women w/ osteoporosis at high risk for fracture; increase bone mass in men w/ history of osteoporotic fracture or multiple risk factors of fracture; glucocorticoid-induced osteoporosis; bone loss in men receiving androgen deprivation therapy for prostate cancer or women receiving adjuvant aromatase inhibitor therapy for breast cancer.
Dosage/Direction for Use
SC 60 mg as a single inj once every 6 mth. Administer inj in the upper arm, upper thigh, or abdomen. All patients should receive Ca 1,000 mg daily & at least 400 IU vit D daily.
Contraindications
Hypersensitivity. Hypocalcemia. Pregnancy.
Special Precautions
Do not take w/ Xgeva. Discontinue if anaphylactic or other clinically significant allergic reactions occurs. Correct pre-existing hypocalcemia prior to initiating therapy. Osteonecrosis of the jaw (ONJ) associated w/ tooth extraction &/or local infection w/ delayed healing; perform routine oral exam prior to initiation of therapy. Atypical subtrochanteric & diaphyseal femoral fractures; consider interruption of therapy in patient presenting w/ an atypical femur fracture; may present pain in the thigh or groin. Risk for multiple vertebral fractures following discontinuation of treatment. Consider transitioning to an alternative antiresorptive therapy if treatment is discontinued. Increased risk of serious infections in patients who uses immunosuppressant agents or w/ impaired immune systems. Dermatologic adverse reactions eg, dermatitis, eczema & rashes. Severe & occasionally incapacitating bone, joint, &/or muscle pain. Monitor patients w/ long term consequences of suppression of bone remodeling. Monitor Ca & mineral levels (eg, P & Mg) w/in 14 days of inj in patients predisposed to hypocalcemia & disturbances of mineral metabolism (eg, history of hypoparathyroidism, thyroid/parathyroid surgery, malabsorption syndromes, excision of small intestine, severe renal impairment (CrCl <30 mL/min or receiving dialysis). Concomitant use w/ drugs associated w/ ONJ. Effective contraception should be used in females of reproductive potential during therapy, & for at least 5 mth after the last dose of therapy. Perform pregnancy testing in all females of reproductive potential prior to administration. Lactation. Not recommended in childn <4 yr. Elderly.
Adverse Reactions
Back pain, arthralgia, pain in extremity, musculoskeletal pain. Postmenopausal osteoporosis: Hypercholesterolemia, cystitis; constipation. Men w/ osteoporosis: Nasopharyngitis. Glucocorticoid-induced osteoporosis: HTN, bronchitis, & headache.
Drug Interactions
Increased risk of developing ONJ w/ drugs associated w/ ONJ. Immunosuppressants. Chemotherapy, corticosteroids, angiogenesis inhibitors.
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 mL x 1's (P18,490/pre-filled syringe)
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