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
PRESCRIBING INFORMATION MEDICATION GUIDE IMPORTANT SAFETY INFORMATION INDICATION FOR PATIENTS CONNECT WITH A REP

Patients like yours could benefit from EVENITY®

doctor_nancy

Barbara

Multiple risk factors, has not experienced fracture

Postmenopausal Osteoporosis History:

  • Currently receiving treatment with an oral bisphosphonate and is on Medicare Part B
  • Has not experienced a fracture despite multiple risk factors, including mother who suffered a hip fracture at age 75, very low BMD, and advanced age
  • Current BMD: -3.0
  • BMD 2 years ago: -3.1

Hypothetical patient

SEE BARBARA’S FULL STORY

Very low BMD and her maternal history of hip fracture are just two signs that Barbara’s first fracture could be sooner than she thinks.

Patients like Barbara need to help reduce the risk of a fracture

Lifestyle:

  • Barbara is 73 and lives in a very active social community
  • She enjoys meeting her neighbors at local events, most of which are within walking distance
  • As she nears the age her mother was when she suffered a hip fracture, Barbara herself is becoming nervous about fractures
  • She worries a fracture may affect her social life and mobility
  • Her doctor recently suggested she get a DXA scan so they can reassess her BMD

Despite Barbara’s current therapy, her BMD remains very low.

Patients like Barbara, with multiple risk factors for fracture, need to build bone quickly. Now is a good time to discuss the benefits of a treatment that will rapidly build new bone within 12 months.

Nancy

Active and treatment naive

Postmenopausal Osteoporosis History:

  • Was unaware that she sustained a vertebral fracture 2 months ago
  • Not currently being treated for osteoporosis
  • Current BMD: -2.59
  • BMD 2 years ago: -2.43

Hypothetical patient

LEARN MORE ABOUT NANCY

Nancy never thought her back pain was the result of an osteoporosis-related vertebral fracture.1

Another fracture can impact patients like Nancy

Lifestyle:

  • Nancy is 65 years old, recently retired from teaching, and is on Medicare
  • She and her husband enjoy hiking now that they both are retired
  • But Nancy has been in constant pain from the undiagnosed fracture
  • When she visited her family practitioner, Nancy was shocked to learn the pain was from a vertebral fracture
  • She worries that another fracture could limit their future hiking adventures

Since Nancy is at the highest risk for fracture in the year after her first one, she is looking for a treatment that will rapidly build strong new bone within 12 months.

Patients like Nancy don't always know their pain could be connected to a fracture. It's important to discuss with postmenopausal osteoporosis patients their risk of fracture and treatment options.

Betsey

Fractured while on a bisphosphonate

Postmenopausal Osteoporosis History:

  • Prescribed a bisphosphonate 12 months ago after a vertebral fracture
  • Recently suffered a wrist fracture even though she takes the bisphosphonate as prescribed
  • Current BMD: -3.31
  • BMD 2 years ago: -3.47

Hypothetical patient

SEE BETSEY'S FULL STORY

Betsey's osteoporosis-related fracture is an indicator that her bones have deteriorated.2

After a fracture, many women like Betsey are concerned about suffering from another2

Lifestyle:

  • At age 71, Betsey recently lost her husband and currently lives alone
  • She takes care of her 4-year-old twin grandchildren while their parents work, and she loves traveling
  • Betsey is worried what an additional fracture could mean
  • Her doctor wants to prescribe a bone builder

Betsey's first fracture was soon followed by another, and she now needs a bone-building treatment that can decrease her risk of another fracture.

Having a second fracture while being treated for osteoporosis can be confusing and frightening. This is a good time to talk with patients like Betsey about the possibility of transitioning to a bone-building treatment.

The 2020 AACE/ACE guidelines state EVENITY® should be considered as initial therapy for appropriate patients

Appropriate patients are those at very high risk for fracture as defined by:3
  • Recent fracture (within the last 12 months)
  • Fractures while on approved osteoporosis therapy
  • Multiple fractures
  • Fractures while on drugs causing skeletal harm
  • Very low T-score (eg, < -3.0)
  • Very high fracture probability by FRAX™(eg, major osteoporotic fracture > 30%, hip fracture > 4.5%)
  • High risk for falls or history of harmful falls
EVENITY® is FDA approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture

High risk for fracture is defined in the EVENITY®Prescribing Information 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.

  • AACE/ACE guidelines recommend

    following EVENITY® with an antiresorptive treatment3

  • AACE/ACE guidelines support

    ongoing monitoring to assess treatment progress3

AACE/ACE Guidelines

AACE = American Association of Clinical Endocrinologists; ACE = American College of Endocrinology; FRAX™ = fracture risk assessment tool.
FRAX™ is a trademark owned by the International Osteoporosis Foundation.

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MichaelMcClung

Michael McClung, MD

Kristy-tough

Kristi Tough, MD

Learn more about tailoring a PMO treatment plan for your patients from leading osteoporosis experts

PMO = postmenopausal osteoporosis.

IMPORTANT SAFETY INFORMATION

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

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.

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References: 1. Cosman F, de Beur SJ, LeBoff MS, et al. Clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25:2359-2381. 2. US Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: US Department of Health and Human Services. Office of the Surgeon General; 2004. 3. 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.