Reports of clinically significant hypersensitivity including anaphylaxis. Hypocalcemia may be exacerbated. Pre-existing 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. Reports of osteonecrosis of the jaw &/or external auditory canal; atypical subtrochanteric & diaphyseal femoral fractures; serious infections. Dental exam w/ preventive dentistry is recommended prior to treatment in patients w/ concomitant risk factors for osteonecrosis of the jaw. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Advise patients to report new or unusual thigh, hip, or groin pain during treatment. Multiple vertebral fractures following discontinuation of treatment. Dermatologic reactions eg, dermatitis, eczema & rashes. Severe & occasionally incapacitating bone, joint, &/or muscle pain. Suppression of bone remodeling. Patients w/ severe renal impairment (CrCl <30 mL/min) or those receiving dialysis. No information regarding presence in human milk, effects on breastfed infant, or effects on milk production. Not approved for use in ped patients. Reports of hypercalcemia in ped patients w/ osteogenesis imperfecta.
Sign Out
