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

EVENITY® was compared to a commonly prescribed antiresorptive2

Phase 3 Event-Driven Study in Postmenopausal Women With Osteoporosis Receiving EVENITY® First Followed by Alendronate vs Alendronate Alone1,2
ARCH Study Design

SC = subcutaneous; PO = orally; QM = monthly; QW = weekly.

Randomized, double-blind, alendronate-controlled, event-driven study1

  • Postmenopausal women, 55-90 years old
  • Bone mineral density (BMD) T-score ≤ -2.5 at total hip or femoral neck, and
  • Either one moderate or severe vertebral fracture or two mild vertebral fractures

    • OR

  • Postmenopausal women, 55-90 years old
  • BMD T-score ≤ -2.0 at total hip or femoral neck, and
  • Either two moderate or severe vertebral fractures or a history of a proximal femur fracture

4093 women randomized to receive 12 months of treatment1

  • Monthly subcutaneous injections of EVENITY® (n = 2046), or
  • Weekly oral alendronate (n = 2047)

All women supplemented with daily calcium and vitamin D

After 12-month treatment period, women in both arms transitioned to open-label alendronate while remaining blinded to their initial treatment

Co-primary endpoints1

  • Incidence of morphometric vertebral fracture at 24 months
  • Time to first clinical fracture (nonvertebral and symptomatic vertebral fracture) through the primary analysis which was performed when at least 330 subjects had a clinical fracture and all subjects had completed the 24-month visit

STUDY ENDPOINTS

Co-primary Endpoints1

  • Incidence of morphometric vertebral fracture at 24 months
  • Time to first clinical fracture (nonvertebral and symptomatic vertebral fracture) through the primary analysis which was performed when at least 330 subjects had a clinical fracture and all subjects had completed the 24-month visit

Key Secondary Endpoints2

  • BMD at lumbar spine, total hip, and femoral neck at 12 and 24 months
  • Incidence of nonvertebral fracture at primary analysis*

Additional Endpoints2

  • Hip fracture, major osteoporotic fracture, and other fracture categories at primary analysis*

*The primary analysis was planned for when clinical fracture events had been confirmed in at least 330 patients and all patients had completed the month 24 visit.1

STUDY POPULATION

Key Inclusion Criteria1,2

  • Postmenopausal women aged 55 to 90 years
  • BMD T-score and fracture history
    • BMD T-score ≤ -2.5 at the total hip or femoral neck, and
        • ≥ 1 moderate or severe vertebral fracture or
        • ≥ 2 mild vertebral fractures

      • OR

    • Postmenopausal women, aged 55-90 years old
    • BMD T-score ≤ -2.0 at the total hip or femoral neck, and
        • ≥ 2 moderate or severe vertebral fractures or
        • A history of proximal femur fracture

Key Exclusion Criteria2,3

  • Contraindications or signs of intolerance to alendronate
  • Recent use of agents affecting bone metabolism

Baseline Characteristics1,2

  • Mean age: 74 years
  • Fracture history: 99.0% with previous osteoporotic fracture and 96% with prevalent vertebral fracture (3.5% mild, 26.9% moderate, 65.7% severe)
  • Mean BMD T-scores: -2.96 (lumbar spine), -2.80 (total hip), -2.90 (femoral neck)
EVENITY® VS PLACEBO
STUDY DESIGN EVENITY® VS TERIPARATIDE STUDY DESIGN

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. EVENITY® (romosozumab-aqqg) prescribing information, Amgen. 2. 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. 3. Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375:1532-1543.