WHAT’S NEXT after a

FRAGILITY FRACTURE?

Consider FORTEO to help reduce the risk
of fracture and help form new bone1

Indications and Usage

  • FORTEO is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, and 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
  • High risk for fracture is 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

    It is not known if FORTEO reduces the risk of fracture in men. Consistent with the FORTEO Prescribing Information, fracture data in patients with GIO are not shown.

    FORTEO is administered as a 20-microgram once-daily dose and is available in a 2.4-mL prefilled delivery device for subcutaneous injection over 28 days.

  • WARNING: POTENTIAL RISK OF OSTEOSARCOMA

    See the Important Safety Information for Complete Boxed Warning.

    • In rats, teriparatide caused an increase in the incidence of osteosarcoma, a malignant bone tumor.
    • Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe FORTEO only for patients for whom potential benefits outweigh potential risk.
    • FORTEO should not be prescribed for patients at increased baseline risk for osteosarcoma (eg, 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).
One fracture due to osteoporosis may lead to another—treat the underlying condition

In a median of 19 months, FORTEO significantly reduced the risk of vertebral and nonvertebral fractures*†‡1

One or More New Vertebral Fractures*1,2

N=448 (placebo); with ≥1 new vertebral fracture(s): 64
N=444 (FORTEO); with ≥1 new vertebral fracture(s): 22
(RR: 0.35; 95% CI, 0.22–0.55)
(AR: placebo 14.3%; FORTEO 5.0%, P≤0.001)

Multiple New Vertebral Fractures*†2

N=448 (placebo); with ≥2 new vertebral fractures: 22
N=444 (FORTEO); with ≥2 new vertebral fractures: 5
(RR: 0.23; 95% CI, 0.09–0.60)
(AR: placebo 4.9%; FORTEO 1.1%)

New Nonvertebral Fragility Fractures*‡§1,2

N=544 (placebo); with ≥1 new nonvertebral fracture(s): 30
N=541 (FORTEO); with ≥1 new nonvertebral fracture(s): 14
(RR: 0.47; 95% CI, 0.25–0.88)
(AR: placebo 5.5%; FORTEO 2.6%, P<0.05)

*Fracture Prevention Trial: Multicenter, prospective, double-blind trial of FORTEO 20 mcg/day (n=541) vs placebo (n=544). 1,637 postmenopausal women with osteoporosis, of whom 90% had a prevalent vertebral fracture at baseline, were evaluated. Mean age: 69. Median duration of exposure to therapy: 19 months (maximum 24 months). All received 1,000 mg/day of calcium and 400–1,200 IU/day of vitamin D.1,2

†The data presented are derived from patients who suffered either 2 or ≥3 new fractures in the FORTEO group vs placebo group.

‡Nonvertebral fracture risk reduction was obtained from pooling data from the following sites: ankle/foot, hip, humerus, pelvis, ribs, wrist, and other sites.

§Fragility fractures were defined as fractures occurring with minimal trauma (eg, falling from standing height).

FORTEO helps build new bone1

Treatment with FORTEO resulted in increased cortical thickness, trabecular bone volume, and connectivity, as well as the conversion of rods to plates.4

Postmenopausal patient with
osteoporosis before FORTEO

Same patient after
21 months on FORTEO

MicroCT images are of paired iliac crest bone biopsies at baseline and after 21 months of treatment with FORTEO. These biopsies are from a 65-year-old postmenopausal woman with osteoporosis with a baseline T-score of –2.7 at the total hip who had a BMD response that was representative of the treatment group.4,5

Bone biopsies were obtained from a subset of women (n=51) who participated in the Fracture Prevention Trial, a multicenter, prospective, double-blind trial of FORTEO 20 mcg/day (n=541) vs placebo (n=544). 1,637 postmenopausal women with osteoporosis, of whom 90% had a prevalent vertebral fracture at baseline, were evaluated. Mean age: 69. Median duration of exposure to therapy: 19 months (maximum 24 months). All received 1,000 mg/day of calcium and 400–1,200 IU/day of vitamin D.1,2,4

Support to help patients start and continue FORTEO therapy

Patient support starts with you. Be sure to reiterate your confidence in FORTEO, and utilize nursing support or an Office Champion to support your treatment goals.

All eligible FORTEO patients can receive injection training and ongoing support through FORTEO Connect.

Qualifying commercially insured patients can also reduce their out-of-pocket costs with the FORTEO Co-pay Card. This offer is invalid for cash-paying patients and patients whose prescription claims are eligible to be reimbursed in whole or in part by any government program.

FORTEO Select Safety Information

The safety and efficacy of FORTEO have not been evaluated beyond 2 years of treatment. The use of FORTEO for more than 2 years during a patient’s lifetime is, therefore, not recommended. Do not use FORTEO in patients with hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.
What you and your patients can expect from FORTEO Connect

There are several ways patients can enroll in FORTEO Connect. They can:

  • Fill out an Enrollment Form in your office. Clicking the link will enable you to download and print the form.
  • Enroll online at FORTEO.com.
  • Call FORTEO Connect. The FORTEO Connect Patient Resource Card can be given to patients so they have the phone number.

Insurance coverage is investigated and patients are informed of their insurance options. Qualifying commercially insured patients are offered the FORTEO Co-pay Card.

Patients have their choice of injection training over the phone or in person with a FORTEO Connect Nurse.

Patients can also opt in for ongoing support from an assigned Personal Support Specialist for up to 24 months of therapy.

Risk Evaluation and Mitigation Strategy (REMS)

This information is being provided as part of the Risk Evaluation and Mitigation Strategy (REMS) plan for FORTEO. REMS plans have been required for certain drugs with serious risks since 2008 by the US Food and Drug Administration to ensure that the benefits of the drug outweigh the risks of the drug.

Important Documents

REMS for FORTEO

Dear Healthcare Provider

Highlighted Information for Prescribers

Prescribing Information

Medication Guide

Educate patients about the voluntary FORTEO Patient Registry and encourage them to enroll.

The FORTEO Patient Registry plays an important role in monitoring the long-term safety of FORTEO, including the potential risk of osteosarcoma. Visit www.forteoregistry.org for more information.

Learn more about osteoporosis and FORTEO
You can find more information about FORTEO at the Lilly Medical website for healthcare professionals.
References: 1. FORTEO Prescribing Information. 2. Neer RM, et al. N Engl J Med. 2001;344:1434-1441. 3. Data on file, Lilly Research Laboratories (FOR20110711A). 4. Jiang Y, et al. J Bone Miner Res. 2003;18:1932-1941. 5. Data on file, Lilly Research Laboratories (FOR20100215A).

Safety Information and Boxed Warning

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 20mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe FORTEO® (teriparatide [rDNA origin] injection) 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).

CONTRAINDICATIONS

Hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

The following categories of patients have increased baseline risk of osteosarcoma and therefore should not be treated with FORTEO: Paget’s disease of bone, pediatric populations and young adults with open epiphyses, or prior external beam or implant radiation therapy.

Patients should be encouraged to enroll in the voluntary FORTEO Patient Registry, which is designed to collect information about any potential risk of osteosarcoma in patients who have taken FORTEO. Enrollment information can be obtained by calling 1-866-382-6813, or by visiting www.forteoregistry.rti.org.

Cases of bone tumor and osteosarcoma have been reported rarely in people taking FORTEO in the post-marketing period. The causality to FORTEO use is unclear.

The safety and efficacy of FORTEO have not been evaluated beyond 2 years of treatment. The use of FORTEO for more than 2 years during a patient’s lifetime is, therefore, not recommended.

Patients with the following conditions also should not receive FORTEO: bone metastases or a history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders.

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

Use with caution in patients with active or recent urolithiasis because of risk of exacerbation. If active urolithiasis or pre-existing hypercalciuria are suspected, measurement of urinary calcium excretion should be considered.

Transient orthostatic hypotension may occur with initial doses of FORTEO. In short-term clinical pharmacology studies, transient episodes of symptomatic orthostatic hypotension were observed in 5% of patients. FORTEO should be administered initially under circumstances where the patient can sit or lie down if symptoms of orthostatic hypotension occur.

Patients receiving digoxin should use FORTEO with caution because FORTEO may transiently increase serum calcium and hypercalcemia may predispose patients to digitalis toxicity.

ADVERSE REACTIONS

The most common adverse reactions in clinical trials include: arthralgia (10.1% FORTEO vs. 8.4% placebo), pain (21.3% FORTEO vs. 20.5% placebo), and nausea (8.5% FORTEO vs. 6.7% placebo). Other adverse reactions include: dizziness, leg cramps, joint aches, and injection site reactions.

USE IN PREGNANCY/NURSING MOTHERS

FORTEO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal studies, FORTEO may cause fetal harm.

It is not known whether teriparatide is excreted in human milk. Breastfeeding mothers should discontinue nursing or FORTEO, taking into account the importance of treatment to the mother.

INSTRUCTIONS FOR FORTEO USE

FORTEO is provided as a fixed-dose, prefilled delivery device that can be used for up to 28 days, including the first injection. The delivery device contains 28 daily doses of 20 mcg each. Do not transfer the contents of the delivery device into a syringe. The FORTEO Delivery Device should be stored under refrigeration at 36° to 46° F (2° to 8° C) at all times. Do not use FORTEO if it has been frozen.

TE HCP ISI 24SEP2012

For more safety information, please see Medication Guide and Prescribing Information, including Boxed Warning regarding osteosarcoma. See User Manual that accompanies the delivery device.

Safety Information and Boxed Warning

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 20mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe FORTEO® (teriparatide [rDNA origin] injection) 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).

CONTRAINDICATIONS

Hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

The following categories of patients have increased baseline risk of osteosarcoma and therefore should not be treated with FORTEO: Paget’s disease of bone, pediatric populations and young adults with open epiphyses, or prior external beam or implant radiation therapy.

Patients should be encouraged to enroll in the voluntary FORTEO Patient Registry, which is designed to collect information about any potential risk of osteosarcoma in patients who have taken FORTEO. Enrollment information can be obtained by calling 1-866-382-6813, or by visiting www.forteoregistry.rti.org.

Cases of bone tumor and osteosarcoma have been reported rarely in people taking FORTEO in the post-marketing period. The causality to FORTEO use is unclear.

The safety and efficacy of FORTEO have not been evaluated beyond 2 years of treatment. The use of FORTEO for more than 2 years during a patient’s lifetime is, therefore, not recommended.

Patients with the following conditions also should not receive FORTEO: bone metastases or a history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders.

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

Use with caution in patients with active or recent urolithiasis because of risk of exacerbation. If active urolithiasis or pre-existing hypercalciuria are suspected, measurement of urinary calcium excretion should be considered.

Transient orthostatic hypotension may occur with initial doses of FORTEO. In short-term clinical pharmacology studies, transient episodes of symptomatic orthostatic hypotension were observed in 5% of patients. FORTEO should be administered initially under circumstances where the patient can sit or lie down if symptoms of orthostatic hypotension occur.

Patients receiving digoxin should use FORTEO with caution because FORTEO may transiently increase serum calcium and hypercalcemia may predispose patients to digitalis toxicity.

ADVERSE REACTIONS

The most common adverse reactions in clinical trials include: arthralgia (10.1% FORTEO vs. 8.4% placebo), pain (21.3% FORTEO vs. 20.5% placebo), and nausea (8.5% FORTEO vs. 6.7% placebo). Other adverse reactions include: dizziness, leg cramps, joint aches, and injection site reactions.

USE IN PREGNANCY/NURSING MOTHERS

FORTEO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal studies, FORTEO may cause fetal harm.

It is not known whether teriparatide is excreted in human milk. Breastfeeding mothers should discontinue nursing or FORTEO, taking into account the importance of treatment to the mother.

INSTRUCTIONS FOR FORTEO USE

FORTEO is provided as a fixed-dose, prefilled delivery device that can be used for up to 28 days, including the first injection. The delivery device contains 28 daily doses of 20 mcg each. Do not transfer the contents of the delivery device into a syringe. The FORTEO Delivery Device should be stored under refrigeration at 36° to 46° F (2° to 8° C) at all times. Do not use FORTEO if it has been frozen.

TE HCP ISI 24SEP2012

For more safety information, please see Medication Guide and Prescribing Information, including Boxed Warning regarding osteosarcoma. See User Manual that accompanies the delivery device.

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