Teriparatide Teva

Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture

Teriparatide Teva is indicated for 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, Teriparatide Teva reduces the risk of vertebral and nonvertebral fractures.

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

Teriparatide Teva is indicated to increase bone mass in men with primary or hypogonadal 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.

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

Teriparatide Teva is indicated 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, 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.

Teriparatide Teva is a synthetic form of the natural human parathyroid hormone and is used by injection to treat osteoporosis. Teriparatide Teva forms new bone, increases bone mineral density and bone strength, and as a result reduces the chance of getting a fracture (broken bone). Teriparatide Teva can be used by men or postmenopausal women with osteoporosis who are at high risk for having fractures. Teriparatide Teva can be used by people who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture, or who cannot use other osteoporosis treatments.

Teriparatide Teva has been used by injection into a vein as a test to help diagnose problems of the parathyroid gland. This test determines whether you have hypoparathyroidism or a type of pseudohypoparathyroidism.

This product, for use as a test to help diagnose problems of the parathyroid gland, was withdrawn from the U.S. market in January 1997.

Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture

The recommended dose is 20 mcg subcutaneously once a day.

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

The recommended dose is 20 mcg subcutaneously once a day.

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

The recommended dose is 20 mcg subcutaneously once a day.

Administration

• Teriparatide Teva should be administered as a subcutaneous injection into the thigh or abdominal wall. There are no data available on the safety or efficacy of intravenous or intramuscular injection of Teriparatide Teva.
• Teriparatide Teva should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Teriparatide Teva is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored.

• Patients and caregivers who administer Teriparatide Teva should receive appropriate training and instruction on the proper use of the Teriparatide Teva delivery device from a qualified health professional.

Treatment Duration

The safety and efficacy of Teriparatide Teva have not been evaluated beyond 2 years of treatment. Consequently, use of the drug for more than 2 years during a patient's lifetime is not recommended.

How supplied

Dosage Forms And Strengths

Multi-dose prefilled delivery device (pen) for subcutaneous injection containing 28 daily doses of 20 mcg.

The Teriparatide Teva delivery device (pen) is available in the following package size:

2.4 mL prefilled delivery device NDC 0002-8400-01 (MS8400).

Storage and Handling

• The Teriparatide Teva delivery device should be stored under refrigeration at 2° to 8°C (36° to 46°F) at all times.
• Recap the delivery device when not in use to protect the cartridge from physical damage and light.
• During the use period, time out of the refrigerator should be minimized; the dose may be delivered immediately following removal from the refrigerator.
• Do not freeze. Do not use Teriparatide Teva if it has been frozen.

Revised: March 13, 2012. Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA