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. Treatment of bone loss in men receiving androgen deprivation therapy for prostate cancer. Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer.
Dosage/Direction for Use
SC 60 mg 6 mthly 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. Severe renal impairment (CrCl <30 mL/min); patients receiving dialysis. Adequate Ca & vit D supplementation. Osteonecrosis of the jaw & external auditory canal. Consider dental exam w/ preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Atypical femoral fractures. Multiple vertebral fractures (MVF) following discontinuation of treatment. Risk of developing serious infections. Consider discontinuation in case of severe dermatologic reactions; severe bone, joint &/or muscle pain. Suppression of bone remodeling. Lactation. Childn.
Adverse Reactions
Back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, cystitis, constipation, arthralgia, nasopharyngitis.
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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