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

Pivotal trial with a primary endpoint of 12-month vertebral fracture1

Phase 3 Study in Postmenopausal Women With Osteoporosis Receiving
EVENITY® First Followed by Prolia® (denosumab) vs Placebo Followed
by Prolia®1,2

FRAME Study Design

SC = subcutaneous; QM = monthly; Q6M = every 6 months.

Randomized, double-blind, placebo-controlled study1

  • Postmenopausal women, 55 to 90 years old
  • Bone mineral density (BMD) T-score ≤ -2.5 at total hip or femoral neck

7180 women randomized to receive 12 months of treatment1

  • Subcutaneous injections of EVENITY® (n = 3589), or
  • Placebo (n = 3591)

All women supplemented with daily calcium and vitamin D

After 12-month treatment period, women in both arms transitioned to open-label antiresorptive therapy (denosumab) for 12 months while remaining blinded to their initial treatment

Co-primary endpoints1

  • New vertebral fracture at month 12 and month 24

STUDY ENDPOINTS

Co-primary Endpoints1

  • New vertebral fracture at 12 and 24 months

Secondary Endpoints2

  • Cumulative incidence of clinical (nonvertebral and symptomatic vertebral), nonvertebral,
    and other fractures* at 12 and 24 months

Additional Endpoints2

  • Change from baseline in BMD at lumbar spine, total hip, and femoral neck at 12 and 24 months

*Other fractures: major nonvertebral fracture, new or worsening vertebral fracture, hip fracture, major osteoporotic fracture, and multiple new or worsening vertebral fractures.

STUDY POPULATION

Inclusion Criteria1,2

  • Postmenopausal women age 55 to 90 years
  • BMD T-score ≤ -2.5 at the total hip or femoral neck
  • At least two vertebrae in the L1 through L4 region and at least one hip that could be evaluated by means of dual-energy x-ray absorptiometry

Select Exclusion Criteria2,*

  • BMD T-score ≤ -3.5 at the total hip or femoral neck
  • History of hip fracture, any severe vertebral fracture, or more than 2 moderate vertebral fractures
  • Recent osteoporosis therapy

Baseline Characteristics1,2

  • Mean age: 71 years
  • Fracture history: 18.3% with prevalent vertebral fracture (most were mild in severity); 21.8%
    with previous nonvertebral fracture
  • Mean BMD T-scores: -2.72 (lumbar spine), -2.47 (total hip), -2.75 (femoral neck)

*Other exclusion criteria: history of metabolic bone disease or conditions affecting bone metabolism, osteonecrosis of the jaw, a 25-hydroxyvitamin D level of less than 20 ng per milliliter, current hypercalcemia or hypocalcemia.

EVENITY® VS ALENDRONATE 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. Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375:1532-1543.