Rx Item-Forteo Pen 20Mcg Dose Inj 2.4Ml By Lilly Eli & Co

FORTEO- teriparatide injection, solution
Eli Lilly and Company

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20-mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe FORTEO� only for patients for whom the potential benefits are considered to outweigh the potential risk. FORTEO should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton) [see Warnings and Precautions (5.1), Adverse Reactions (6.2), and Nonclinical Toxicology (13.1)].

1 INDICATIONS AND USAGE

1.1 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 (14.1)].

1.2 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 (14.2)].

1.3 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 (14.3)].

2 DOSAGE AND ADMINISTRATION

2.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
The recommended dose is 20 mcg subcutaneously once a day.

2.2 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.

2.3 Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture
The recommended dose is 20 mcg subcutaneously once a day.

RX ITEM-Forteo Pen 20Mcg Dose Inj 2.4Ml
NDC 00002-8400-01 UPC/GTIN No.3-00028-40001-2 Mfg.Part No.840001

Forteo Pen 20Mcg Dose Inj 2.4Ml By Lilly
BRAND: FORTEO NDC: 00002-8400-01,2840001 UPC: 3-00028-40001-2,300028400012 Lilly Eli & Co

TERIPARATIDE SUB-Q PEN IN
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