All the Active Ingredient Drugs
Monoclonal Antibody. Denosumab 60 mg/ml. PRE-FILLED SYR (sol. for inject): 1. 60 mg admin. as a single SC inj. once every 6 mnths. into the thigh, abdom. or upper arm. Pts. must be adeq. supplem. with calcium & vit. D. Pts. treated with Prolia should be given the package leaflet and the pt. safety inform. card. See lit.
Tmt. of osteoporosis in postmenopaus. women & in men at incr. risk of fractur. In postmenopaus. women Prolia signific. reduces the risk of vertebral, non-vertebr. & hip fractures.
Tmt. of bone loss assoc. with hormone ablation in men with prostate cancer at incr. risk of fractur. In men with prostate cancer receiv. hormone ablat., Prolia signific. reduces the risk of verteb. fractur.
Tmt. of bone loss assoc. with long-term system. glucocortic. ther. of a dly. dosage equiv. to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 3 mnths., in adult pts. at high risk of fracture.
C/I: Hypocalc., hypersens.
Monoclonal Antibody. Denosumab 120 mg / 1.7 ml (70 mg/ml). VIAL (sol. for SC inj.): 1/ 4 x 120 mg.
Supplement. of at least 500 mg Ca and 400 IU vit D dly is req. in all pts, unless hypercalcemic. Prevent. of skelet. related events in adult. with multip. myeloma and in adult. with bone metastas. from solid tumor.: 120 mg admin. once every 4 wks. into the thigh, abdom. or upper arm.
Giant cell tumor of bone: 120 mg admin. once every 4 wks.
into the thigh, abdom. or upper arm with addit. 120 mg doses on 8th d and 15th d. of tmt. of the 1st month of therapy. See lit.
Prevent. of skeletal related events (patholog. fract., radiat.to bone, spinal cord compress. or surg.to bone) in adult. with multip. myeloma and in adults with bone metastases from solid tumors.
Tmt. of adults and skeletally mature adolesc. with giant cell tumor of bone that is unresect. or where surg. resect. is likely to result in severe morbid..
C/I: Hypersens.
Severe, untreat. hypocalcem.
Unhealed lesions from dental or oral surg.
