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Prolia博力加

Prolia

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Denosumab
Indications/Uses
Treatment of postmenopausal women w/ osteoporosis at high risk for fracture. Treatment to increase bone mass in men w/ osteoporosis at high risk for fracture. Treatment of glucocorticoid-induced osteoporosis in men & women at high risk of fracture who are either initiating or continuing systemic glucocorticoids (prednisone ≥7.5 mg daily) & expected to remain on glucocorticoids for at least 6 mth. Treatment of bone loss in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. Treatment of bone loss in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Dosage/Direction for Use
SC 60 mg once every 6 mth in the upper arm, upper thigh or abdomen.
Contraindications
Hypersensitivity. Pre-existing hypocalcemia. Pregnancy.
Special Precautions
Discontinue use if anaphylactic or other clinically significant allergic reaction occurs. Hypocalcemia must be corrected prior to initiating therapy. Concomitant use of calcimimetic drugs may worsen hypocalcemia risk; closely monitor serum Ca. Ensure adequate Ca & vit D supplementation. Risk of osteonecrosis of the jaw or external auditory canal; atypical femoral fractures; serious infections. Consider dental exam w/ preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Multiple vertebral fractures (MVF) following discontinuation of treatment. Consider discontinuation in case of severe dermatologic reactions; severe bone, joint &/or muscle pain. Suppression of bone remodeling. Patients w/ severe renal impairment (CrCl <30 mL/min) or patients receiving dialysis. Advise females of reproductive potential to use effective contraception during therapy, & for at least 5 mth after the last dose. Lactation. Not recommended in ped patients <4 yr.
Adverse Reactions
Back pain. Patients w/ postmenopausal osteoporosis: Pain in extremity, musculoskeletal pain, hypercholesterolemia, cystitis. Men w/ osteoporosis: Arthralgia, nasopharyngitis. Patients w/ glucocorticoid-induced osteoporosis: HTN, bronchitis, headache. Patients w/ bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer: Arthralgia.
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 pre-filled syringe 60 mg/mL
Packing/Price
1 mL x 1's
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