Teriparatide

FORTEO 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.

Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors. Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide is not expected to accumulate in bone or other tissues. The skeletal effects of teriparatide depend upon the pattern of systemic exposure.

Recommended dosage is 20 mcg subcutaneously once a day. Consider supplemental calcium and Vitamin D based on individual patient needs. Administer as a subcutaneous injection into the thigh or abdominal region. Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur. Use of FORTEO for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture

FORTEO 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. Patients with severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO

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. 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. Hypercalcemia and Cutaneous Calcification: Avoid in patients known to have an underlying hypercalcemic disorder.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Osteosarcoma Hypercalcemia and Cutaneous Calcification Risk of Urolithiasis Orthostatic Hypotension Risk of Digoxin Toxicity Most common adverse reactions (>10%) include: arthralgia, pain, and nausea

Digoxin: Transient hypercalcemia may predispose patients to digitalis toxicity Digoxin Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. FORTEO may transiently increase serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when FORTEO is used in patients receiving digoxin.

Store FORTEO under refrigeration at 2° to 8°C (36° to 46°F) at all times except when administering the product. When using FORTEO, minimize the time out of the refrigerator, deliver the dose immediately following removal from the refrigerator. Do not freeze.