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Forteo

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Forteo

Indications
Dosage
How Supplied

INDICATIONS

Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture

FORTEO 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, FORTEO reduces the risk of vertebral and nonvertebral fractures [see Clinical Studies].

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

FORTEO 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 [see Clinical Studies].

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

FORTEO 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 [see Clinical Studies].

DOSAGE AND ADMINISTRATION

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

  • FORTEO 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 FORTEO.
  • FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see WARNINGS AND PRECAUTIONS].
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. FORTEO 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 FORTEO should receive appropriate training and instruction on the proper use of the FORTEO delivery device from a qualified health professional [see PATIENT INFORMATION].

Treatment Duration

The safety and efficacy of FORTEO 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 FORTEO 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 FORTEO 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 FORTEO if it has been frozen.

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

Last reviewed on RxList: 4/13/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Forteo - User Reviews

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