테리파라타이드아세트산염

is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures. To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. FORTEO is a parathyroid hormone analog, (PTH 1-34), indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy ( 1 ) Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy ( 1 ) Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy ( 1 )

is contraindicated in patients with a history of severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.2 )] . Patients with severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO( 4 )

Hypersensitivity Reactions : Anaphylaxis, angioedema, and urticaria have been reported in patients treated with parathyroid hormone analogs, including FORTEO. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with FORTEO, initiate supportive care, and monitor until signs and symptoms resolve. Discontinue FORTEO permanently in patients with a severe hypersensitivity reaction to FORTEO. ( 5.1 ) Osteosarcoma : Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget's disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. ( 5.2 ) Hypercalcemia and Cutaneous Calcification : Avoid in patients known to have an underlying hypercalcemic disorder. Discontinue in patients developing worsening of previously stable cutaneous calcification. ( 5.3 ) Risk of Urolithiasis : Consider the risk/benefit in patients with active or recent urolithiasis because of risk of exacerbation ( 5.4 ) Orthostatic Hypotension : Transient orthostatic hypotension may occur with initial doses of FORTEO ( 5.5 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported in patients treated with parathyroid hormone (PTH) analogs, including FORTEO [ see Adverse Reactions ( 6.2 ) ]. If signs or symptoms of …

8.1 Pregnancy Risk Summary There are no available data on FORTEO use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing FORTEO when pregnancy is recognized. In animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m 2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see Data) . The background risk of major …