Mechanism of Action: Treatment with FORTEO (teriparatide injection) stimulates an increase in remodeling with positive bone balance2,3

FORTEO is a Pro-Remodeling Anabolic Agent2,3

  • Bone remodeling is a coupled process by which osteoclasts remove existing or damaged bone matrix (resorption), and then osteoblasts refill the resorption cavities with new bone (formation).4
  • This coupled process of continuous renewal helps to maintain mechanical strength of the skeleton4
  • In postmenopausal osteoporosis, increased bone turnover results in increased resorption, underfilling of resorption sites, and a deficit of bone with every cycle5
  • This can result in thinning of bone trabeculae, loss of connectivity, and a reduction in bone strength5
FORTEO is a Pro-Remodeling Anabolic Agent
FORTEO is a Pro-Remodeling Anabolic Agent
FORTEO is a Pro-Remodeling Anabolic Agent

Treatment with FORTEO stimulates an increase in remodeling with positive bone balance,2,3 resulting in renewal of bone by:2,3

  • Removing older or fatigued bone
  • Adding more bone than was present prior to treatment

FORTEO Select Safety Information

Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the post-marketing setting in patients taking FORTEO. Risk factors for development of calciphylaxis include underlying autoimmune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue in patients developing calciphylaxis or worsening of previously stable cutaneous calcification.

The effect of FORTEO on markers of bone turnover

FORTEO significantly increased both markers of bone remodeling 8,9

  • Concentrations of P1NP increased 129% above baseline at 1 month and plateaued between 6 and 12 months at about 290%
  • The increases in CTX reached significance after 3 months of treatment at 86% above baseline and plateaued between 6 and 12 months at about 146%

Please see study design for SHOTZ study.

The effect of Forteo on markers of Bone Turnover

*P<0.001 for percent change from baseline. SE=standard error. P1NP=procollagen type 1 N-terminal propeptide. CTX= Carboxy-Terminal cross-linked telopeptide of type 1 collagen.

FORTEO Select Safety Information

Consider the risks and benefits in patients with active or recent urolithiasis because of risk of exacerbation.

FORTEO helped stimulate early and sustained bone formation in 2 randomized clinical studies

FORTEO helped stimulate new bone formation in cancellous and cortical bone as early as 3 months*, and sustained new bone formation throughout 24 months* of treatment 6,7

*3-month data are from the AVA study, 6- and 24-month data are from the SHOTZ study.

AVA Study 3 mo cancellous
AVA Study 3 mo cortical
SHOTZ Study 6 mo cancellous
SHOTZ Study 6 mo cortical
SHOTZ Study 24 mo cancellous
SHOTZ Study 24 mo cortical

Continuous and statistically significant bone formation demonstrated that anabolic action continued through 24 months of treatment with FORTEO.7

Please see study designs for AVA and SHOTZ studies.

FORTEO Select Safety Information

If FORTEO-treated patients have pre-existing hypercalciuria or suspected/known active urolithiasis, consider measuring urinary calcium excretion.

In a clinical study, FORTEO helped stimulate new bone with mineral properties consistent with younger bone age*10

FORTEO treatment increased the amount of newly formed bone matrix with lower, more heterogeneous mineral content (blue arrows), a property consistent with younger bone age.*

*Younger bone age is characterized by newly formed bone matrix with lower, more heterogeneous bone mineral content.

Analysis of mineralization at the tissue level shows that FORTEO promotes ongoing formation of new bone

Forteo helped stimulate new bone with mineral properties

FORTEO Select Safety Information

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


References

2. FORTEO Prescribing Information, 3. Riggs BL, Parfitt AM. J Bone Miner Res. 2005;20:177-184., 4. Raggatt LJ, Partridge NC. J Biol Chem. 2010;285:25103-25108., 5. Seeman E. Rheumatology (Oxford). 2008;47:iv2-iv8., 6. Dempster DW, et al. J Clin Endocrinol Metab. 2016;101:1353-1363., 7. Dempster DW, et al. J Bone Miner Res. 2016;31:1429-1439., 8. Dempster D, et al. J Clin Endocrinol Metab. 2012;97(8):2799-2808., 9. Data on file, Lilly Research Laboratories (FOR20161208A)., 10. Dempster DW, et al. J Bone Miner Res. 2016; 31(8):1527-1535.

Indications and Important Safety Information
Indications and Usage

FORTEO is indicated:

  • for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or 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.
  • to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
  • 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 or who have failed or are intolerant to other available osteoporosis therapy.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

FORTEO is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

Osteosarcoma: Osteosarcoma has been reported in patients treated with FORTEO in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. Avoid use in patients with increased baseline risk of osteosarcoma including patients with open epiphyses (pediatric and young adult patients), metabolic bone diseases including Paget’s disease of the bone, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. There is limited data assessing the risk of osteosarcoma beyond 2 years.


Hypercalcemia and Cutaneous Calcification: FORTEO may cause hypercalcemia and may exacerbate hypercalcemia in patients with pre-existing hypercalcemia. Avoid FORTEO in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.


Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the post-marketing setting in patients taking FORTEO. Risk factors for development of calciphylaxis include underlying autoimmune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue in patients developing calciphylaxis or worsening of previously stable cutaneous calcification.


Risk of Urolithiasis: Consider the risks and benefits in patients with active or recent urolithiasis because of risk of exacerbation. If FORTEO-treated patients have pre-existing hypercalciuria or suspected/known active urolithiasis, consider measuring urinary calcium excretion.


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


Risk of Digoxin Toxicity: Hypercalcemia may predispose patients to digitalis toxicity because FORTEO transiently increases serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when FORTEO is used in patients receiving digoxin.

ADVERSE REACTIONS

The most common adverse reactions in clinical trials included: 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 included: dizziness, leg cramps, joint aches, and injection site reactions.


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

USE IN SPECIFIC POPULATIONS

Pregnancy & Lactation
There are no available data on FORTEO use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing FORTEO when pregnancy is recognized. It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. Avoid FORTEO use in women who are breastfeeding.


Pediatric Use
The safety and effectiveness of FORTEO have not been established in pediatric patients. Pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses. Avoid use due to increased baseline risk of osteosarcoma.

For more safety information, please click to see Medication Guide and Full Prescribing Information. Click to see Full User Manual that accompanies the delivery device.

Forteo® is a registered trademark owned or licensed by Eli Lilly AND Company, its subsidiaries, or affiliates.
TE HCP ISI 16NOV2020