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Basic Drug Info
Drug Name:Forteo
Manufacturer:Eli Lilly and Company
Other Info:

Literature revised June 25, 2008Manufactured by Lilly France - F-67640 Fegersheim, France for Eli Lilly and Company - Indianapolis, IN 46285, USAwww.forteo.comCopyright © 2002, 2008, Eli Lilly and Company.

All rights reserved.



Clinical Trials:


Indications and Usage

FORTEO is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture.

These include women with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment (see BLACK BOX WARNING).

In postmenopausal women with osteoporosis, FORTEO increases BMD and reduces the risk of vertebral and nonvertebral fractures.FORTEO is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.

These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment (see BLACK BOX WARNING).

In men with primary or hypogonadal osteoporosis, FORTEO increases BMD.

The effects of FORTEO on risk for fracture in men have not been studied.FORTEO reduces the risk of vertebral fractures in postmenopausal women with osteoporosis.FORTEO reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis.FORTEO increases vertebral and femoral neck BMD in postmenopausal women with osteoporosis and in men with primary or hypogonadal osteoporosis.The effects of FORTEO on fracture risk have not been studied in men.
Osteoporosis -- Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

OSTEOPOROSIS FRACTURE --

Contraindications
FORTEO should not be given to patients with hypersensitivity to teriparatide or to any of its excipients.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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 (see BLACK BOX WARNING and PRECAUTIONS; Carcinogenesis).The following categories of patients have increased baseline risk of osteosarcoma and therefore should not be treated with FORTEO:Paget’s disease of bone.

FORTEO should not be given to patients with Paget’s disease of bone.

Unexplained elevations of alkaline phosphatase may indicate Paget’s disease of bone.Pediatric populations.

FORTEO has not been studied in pediatric populations.

FORTEO should not be used in pediatric patients or young adults with open epiphyses.Prior external beam or implant radiation therapy involving the skeleton.

FORTEO should not be given to such patients.Patients with bone metastases or a history of skeletal malignancies should be excluded from treatment with FORTEO.Patients with metabolic bone diseases other than osteoporosis should be excluded from treatment with FORTEO.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.