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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EVENITY® VS ALENDRONATE (ARCH)

EVENITY® for 12 months followed by alendronate provided superior vertebral and nonvertebral fracture risk reduction vs alendronate alone1

Start with EVENITY® first after fracture when your patients' risk of another is at its highest1,2

EVENITY® First Followed by Alendronate vs Alendronate Alone1,3
Fracture Risk Reduction
Incidence of fractures (%)

This was an event-driven trial and the duration of follow-up varied across subjects. The median duration of subject follow-up for the primary analysis period was 33 months1

EVENITY® for 12 months followed by alendronate reduced the incidence of clinical fracture (nonvertebral and symptomatic vertebral fracture) at primary analysis (median 33 months) (P < 0.001)1

*Absolute and relative risk reductions are based on the Mantel‑Haenszel method adjusting for age strata, baseline total hip BMD T‑score (≤ -2.5,>-2.5), and presence of severe vertebral fracture at baseline.

† P value based on logistic regression model (new vertebral fracture) or Cox proportional hazards model (other fracture types) adjusting for age strata, baseline total hip BMD T‑score, and presence of severe vertebral fracture at baseline.

‡Nonvertebral fractures excluded fractures of the skull, facial bones, metacarpals, fingers, and toes. Pathologic or high trauma fractures were also excluded.

ARR = absolute risk reduction.

EVENITY® rapidly increased BMD
in just 12 months1

BMD superiority vs alendronate across key sites1

  • Within 12 months vs alendronate, EVENITY® demonstrated significant improvements in BMD at the lumbar spine, total hip, and femoral neck
  • Gains were sustained after follow-on treatment with alendronate
EVENITY® First Followed by Alendronate vs Alendronate Alone1,3
BMD Gains at 12, 24, and 36 Months

LUMBAR SPINE

Lumbar Spine. Change from baseline (%)

*Number of subjects with values at baseline and at least one post-baseline visit at or before month 36.

† P < 0.001 based on ANCOVA model using last-observation-carried-forward (LOCF) adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

TOTAL HIP

Total Hip. Change from baseline (%)

*Number of subjects with values at baseline and at least one post-baseline visit at or before month 36.

† P < 0.001 based on ANCOVA model using last-observation-carried-forward (LOCF) adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

FEMORAL NECK

Femoral Neck. Change from baseline (%)

*Number of subjects with values at baseline and at least one post-baseline visit at or before month 36.

† P < 0.001 based on ANCOVA model using last-observation-carried-forward (LOCF) adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

EVENITY® VS PLACEBO EFFICACY EVENITY® VS TERIPARATIDE EFFICACY

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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References: 1. EVENITY® (romosozumab-aqqg) prescribing information, Amgen. 2. van Geel TA, van Helden S, Geusens PP, Winkens B, Dinant GJ. Clinical subsequent fractures cluster in time after first fractures. Ann Rheum Dis. 2009;68:99-102. 3. Saag KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med. 2017;377:1417-1427.