
1. Treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as having a history of osteoporotic fracture or multiple risk factors for fracture) or patients 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.
2. 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.
3. 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.
1. Recommended Dosage:
1.1 20 mcg subcutaneously once a day.
1.2 Consider supplemental calcium and Vitamin D based on individual patient needs.
2. Administration Instructions:
2.1 Administer as a subcutaneous injection into the thigh or abdominal region.
2.2 Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
2.3 Inspect visually for particulate matter and discoloration prior to administration (FORTEO is a clear and colorless liquid).
2.4 Patients and/or caregivers should receive appropriate training and instruction on proper use.
2.5 Discard the delivery device 28 days after first use.
3. Treatment Duration:
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.