Indicated for:

Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture:

•  The treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, 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.

Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture:

• 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.

Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture:

• 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.

The recommended dosage is 20 mcg given subcutaneously once a day. Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate.

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.

An increase in the incidence of osteosarcoma (a malignant bone tumor) was observed in male and female rats treated with teriparatide. Osteosarcoma has been reported in patients treated with FORTEO in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of FORTEO use.

Avoid FORTEO use in patients with (these patients are at increased baseline risk of osteosarcoma):

• Open epiphyses (pediatric and young adult patients) (FORTEO is not approved in pediatric patients)
• Metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone
• Bone metastases or a history of skeletal malignancies
• Prior external beam or implant radiation therapy involving the skeleton
• Hereditary disorders predisposing to osteosarcoma

FORTEO has not been studied in patients with pre-existing hypercalcemia. FORTEO may cause hypercalcemia and may exacerbate hypercalcemia in patients with pre-existing hypercalcemia. Avoid FORTEO in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.

Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the postmarketing setting in patients taking FORTEO. Risk factors for development of calciphylaxis include underlying autoimmune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue FORTEO in patients who develop calciphylaxis or worsening of previously stable cutaneous calcification.

FORTEO may increase serum calcium, urinary calcium, and serum uric acid.

Transient orthostatic hypotension may occur with initial doses of FORTEO.

Use with caution in patients with active or recent urolithiasis because of risk of exacerbation. As with all peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

Use FORTEO with caution in patients receiving digoxin. Transient hypercalcemia may predispose patients to digitalis toxicity. 

There are no adequate and well-controlled studies of FORTEO in pregnant women. Animal studies: skeletal deviations and variations.

It is not known whether teriparatide is excreted in human milk. Because of the potential for tumorigenicity shown for teriparatide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under the age of 18. GoToSource

• Prevent complete fractures in symptomatic patients with long-term treatment with bisphosphonates. GoToSource

• Osteogenesis imperfecta. GoToSource

• Bisphosphonate-associated incomplete atypical femoral fractures. GoToSource

• Spinal cord injury. GoToSource

• Idiopathic osteoporosis in premenopausal women. GoToSource

• Rheumatoid arthritis. GoToSource

Subungual exostosis (benign bone tumor under nail bed). GoToSource

Hypercalcemia (elevated calcium levels). GoToSource

Osteosarcoma (bone cancer). GoToSource

Increased serum uric acid and acute gout. GoToSource

Leg cramps. GoToSource

Asthenia (loss or lack of energy and strength), neck pain, hypertension (high blood pressure), angina pectoris (chest pain or discomfort due to coronary heart disease), syncope (temporary loss of consciousness), constipation, depression, insomnia and vertigo. GoToSource

Nasopharyngitis. GoToSource

Hypotension (low blood pressure). GoToSource

Lawsuits filed for bone cancer and fatal cardiovascular disorders.