INDICATION

EVENITY® is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy...Read More

The anabolic effect of EVENITY® wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY® use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered. Close
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There is a critical need to build bone and reduce fracture risk in women with postmenopausal osteoporosis (PMO) who are at very high risk for fracture1

The 2020 AACE guidelines for postmenopausal osteoporosis include recommendations for anabolics, like EVENITY®, as initial treatment options for patients at very high risk for fracture2

AACE fracture risk assessment and treatment recommendations2

VERY HIGH FRACTURE RISK2

Criteria for very high fracture risk may include:

  • Recent fracture (eg, within the past 12 months)
  • Fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (eg, long-term glucocorticoids)
  • Very low T-score (eg, less than –3.0)
  • High risk for falls or history of injurious falls
  • Very high fracture probability by FRAX® (eg, > 30% for major osteoporotic fractures; > 4.5% for hip fractures)

Recommended treatment options

Recommended initial therapy:* abaloparatide, denosumab, romosozumab-aqqg, teriparatide, zoledronate

Alternative therapy: alendronate and risedronate

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Take a proactive, bone-building approach for your PMO patients at very high risk of fracture

FRAX® is a trademark owned by the International Osteoporosis Foundation.

*Therapies listed are also recommended for patients unable to use oral therapies.2

AACE, American Association of Clinical Endocrinology.

Evolving evidence suggests that the treatment you
start with matters

2024 American Society for Bone and Mineral Research/Bone Health and Osteoporosis Foundation (ASBMR/BHOF) Task Force position statement on goal-directed osteoporosis treatment recommends anabolic therapy as initial treatment for patients at very high risk for fracture, guided by BMD and fracture history to rapidly maximize BMD and reduce fracture risk.3,*

A goal-directed approach to management of osteoporosis and fracture risk ensures the most appropriate initial treatment and treatment sequence are selected, which is in contrast to the current approach (same first treatment for all regardless of individualized risk).3

Postmenopausal osteoporosis patients recommended for anabolic treatment as first choice include:3,†

†The above chart presents select treatment algorithms in the position statement. For additional information, please see publication.3

*The 2024 ASBMR/BHOF Task Force position statement represents the consensus of the ASBMR/BHOF Task Force on goal-directed osteoporosis treatment, based on interpretation of the best evidence available. The position statement is not a clinical guideline.3

BMD, bone mineral density.

Few women being treated for PMO receive anabolic therapy, despite very high fracture risk1,4,5

33% of women with postmenopausal osteoporosis (PMO) are at very high risk for fracture per AACE guidelines

Prevalence of very high fracture risk (VHFR)

33% of women with postmenopausal osteoporosis (PMO) were identified as meeting AACE criteria for very high fracture risk1,‡,§

6% of newly treated women with PMO at VHFR were treated with anabolics

Anabolic agent usage in VHFR

6% of newly treated women with PMO at VHFR were treated with anabolics4,5,**

‡Real-world study: A retrospective, observational cohort study including 5,078,111 patients, of which 4,417,465 were women ≥ 50 years, and using pharmacy and medical claims data from Symphony, evaluated the prevalence of women who were at very high risk for fracture according to 2020 AACE guidelines and treatment patterns for this population. Patients were included if they were identified as having an osteoporosis (OP) diagnosis and met the AACE criteria for very high risk for fracture between 1/1/2018 and 12/31/2018. 12 months of patient data were available before and after the point during the identification window at which they qualified for being at very high risk according to AACE guidelines criteria.1

§Excluding patients with upper gastrointestinal disorder.1

**10,528 women ≥ 60 years old who newly initiated treatment for OP between 4/1/19 and 9/30/20 and with a valid value of body mass index and ethnicity within 15 months prior to OP treatment initiation were included in this analysis.4 New use was defined as no prior use of that specific OP therapy or class of therapy (ie, oral BPs, PTH analogues) using all available historical claims data. Anabolic agents included romosozumab-aqqg and PTH analogues (teriparatide and abaloparatide). Individuals with history of Paget's disease of bone, metastatic cancer, or a cancer diagnosis on the same claim as the OP prescription were excluded.4,5 The data source of this analysis is Optum's de-identified Integrated Claims-Clinical dataset, which is a medical claims database that represents the medical experience of insured employees and their dependents from both affiliated commercial and Medicare Advantage plans.5

AACE, American Association of Clinical Endocrinology; BP, bisphosphonates; PTH, parathyroid hormone.

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References: 1. Diffenderfer BW, Wang Y, Pearman L, Pyrih N, Williams SA. Real-world management of patients with osteoporosis at very high risk of fracture. J Am Acad Orthop Surg. 2023;31:e327-e335. 2. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis-2020 Update. Endocr Pract. 2020;26(Suppl 1):1-46. 3. Cosman F, Lewiecki EM, Eastell R, et al. Goal-directed osteoporosis treatment: ASBMR/BHOF task force position statement 2024. J Bone Miner Res. 2024;39:1393-1405. 4. Chien H, Kim M, Deignan C, McDermott M, Lin T. Differences in osteoporosis treatment utilization according to baseline fracture risk among US PMO women. Presented at: American Society for Bone and Mineral Research Annual Meeting; September 9–12, 2022; Austin, TX. 5. Data on File, Amgen; 2024.

IMPORTANT SAFETY INFORMATION FOR EVENITY®

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH

EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued.

In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY® compared to those treated with alendronate.

Contraindications: EVENITY® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY®. EVENITY® is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria.

Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY®-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY®.

Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY®. Correct hypocalcemia prior to initiating EVENITY®. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement patients with calcium and vitamin D while on EVENITY®.

Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY®. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY®. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.

For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITY® should be considered based on benefit-risk assessment.

Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.

During EVENITY® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY® therapy should be considered based on benefit-risk assessment.

Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY® were arthralgia and headache.

EVENITY® is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Please see EVENITY® full Prescribing Information, including Medication Guide.

IMPORTANT SAFETY INFORMATION FOR EVENITY®

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH

EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the

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