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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Active-controlled BMD study of EVENITY® vs teriparatide in women with postmenopausal osteoporosis at high risk of fracture transitioning from oral bisphosphonates1

EVENITY® compared with another commonly used bone builder through 12 months1

Phase 3 study in postmenopausal women with osteoporosis receiving
EVENITY® vs teriparatide1

BMD, bone mineral density; QD, once daily; QM, monthly; SC, subcutaneous.

Consider open-label study limitations when interpreting results. This open-label study was not blinded.1

Study details1

  • A randomized, open-label study of 436 postmenopausal women aged 55 to 90 years with osteoporosis and a history of nonvertebral fracture after age 50 or vertebral fracture at any time
  • Women transitioned from bisphosphonate therapy to either EVENITY® or teriparatide. All patients were supplemented with calcium and vitamin D

Primary endpoint1

Percent change from baseline in total hip BMD through month 12 (mean of months 6 and 12)

Secondary endpoints1

Percent change from baseline in:

  • BMD by DXA at total hip, femoral neck, and lumbar spine at months 6 and 12
  • Cortical and integral volumetric BMD by QCT at the hip at 6 and 12 months
  • Hip strength, estimated by finite element analysis at months 6 and 12

Mean age1

71.5 years

Fracture history1

100% of patients had experienced a previous fracture

Treatment history1

100% of patients had used oral bisphosphonates during the 3 years prior to screening, with median use of 6.2 years

  • Study population1

    Inclusion criteria1

    • Postmenopausal women aged 55 to 90 years
    • Patients had received oral bisphosphonates for at least 3 years before screening and alendronate the year immediately before screening
    • Patients had a history of nonvertebral fracture after age 50 years or vertebral fracture
    • BMD T-score ≤ –2.5 at total hip, femoral neck, or lumbar spine
    • At least one hip and at least two vertebrae in the L1–L4 region

    Exclusion criteria1

    • Contraindications or signs of intolerance to teriparatide
    • Recent use of other agents affecting bone metabolism
    • A serum 25-hydroxy vitamin D concentration of less than 50 nmol/L
    • A history of metabolic or bone disease

    Baseline characteristics1

    • Mean age: 71.8 years in EVENITY® group; 71.2 years in teriparatide group
    • Fracture history: 100% of patients had experienced a previous fracture
    • Mean BMD T-scores: –2.83 (lumbar spine), –2.27 (total hip), –2.49 (femoral neck) in EVENITY® group; –2.87, –2.21, –2.43, respectively, in teriparatide group
    • 100% of patients had used oral bisphosphonates in 3 years before screening with median use of 6.2 years

All patients received daily calcium and vitamin D throughout the study.1

DXA, dual-energy X-ray absorptiometry; QCT, quantitative CT.

EVENITY® vs teriparatide: BMD Results1

BMD results are not meant to imply fracture efficacy and should not be extrapolated to predict differences in fracture efficacy.1

Percent change in BMD – mean of months 6 and 121

Percent change in BMD – at months 6 and 121

*P < 0·05 vs baseline.1

†P < 0·0001 vs baseline.1

‡P < 0·0001 vs teriparatide.1

The safety profile of EVENITY® in this
BMD study1

Adverse events1

STRUCTURE: EVENITY® vs Teriparatide adverse events

Data are number of patients (%). Denomination is number of patients who received at least one dose of investigational product.1

*Events reported as 10% or higher in either treatment group.1

†Reported as different types of injection site reactions with the most frequent as injection site pain in the EVENITY® group.1

‡Includes events reported as hypocalcemia and decreased blood calcium concentration.1

§Adverse events leading to study discontinuation in each treatment group were single event types with no particular pattern.1

**There were two deaths during the trial, unrelated to investigational product; one participant with leukemia in the EVENITY® group had a hemorrhage and one participant in the teriparatide group had a gastrointestinal hemorrhage.1

See dosing and administration schedule

Reference: 1. Langdahl BL, Libanati C, Crittenden DB, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017;390:1585-1594.

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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