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.
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