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 PLACEBO (FRAME)

Consider the safety profile of EVENITY® in the 12-month double-blind period of the placebo-controlled study

Major Adverse Cardiac Events (MACE)1,*

During the 12-month double-blind treatment period of the placebo-controlled trial (FRAME):

  • Myocardial infarction occurred in 9 women (0.3%) in the EVENITY® group and 8 women (0.2%) in the placebo group
  • Stroke occurred in 8 women (0.2%) in the EVENITY® group and 10 women (0.3%) in the placebo arm
  • Cardiovascular death occurred in 17 women (0.5%) in the EVENITY® group and 15 women (0.4%) in the placebo group
  • MACE resulted in incidences of 30 (0.8%) in the EVENITY® group and 29 (0.8%) in the placebo group
  • FRAME MACE Hazard Ratio: 1.03 ([0.62, 1.72]) for EVENITY® compared to placebo

*MACE is a composite endpoint of positively adjudicated myocardial infarction, stroke, and cardiovascular death.

These events occurred in patients with and without a history of myocardial infarction or stroke.

Includes fatal events adjudicated as CV-related or undetermined.

More than 7000 women were included in the pivotal trial, where 3581 patients received EVENITY®1

Adverse Reactions Occurring in ≥ 2% of EVENITY®-treated Women1

FRAME
Preferred Term
Placebo
(N = 3576) n (%)
EVENITY®
(N = 3581) n (%)
Arthralgia
434 (12.1)
468 (13.1)
Headache
208 (5.8)
235 (6.6)
Muscle spasms
140 (3.9)
163 (4.6)
Edema peripheral
67 (1.9)
86 (2.4)
Asthenia
79 (2.2)
84 (2.3)
Neck pain
54 (1.5)
80 (2.2)
Insomnia
68 (1.9)
72 (2.0)
Paresthesia
62 (1.7)
72 (2.0)
Adjudicated Cases of ONJ & AFF
7157 patients were evaluated during the 12-month period1,*
  • One adjudicated case of ONJ1
    Occurred within 12 months of EVENITY® treatment1,2,†
  • One adjudicated case of AFF1,‡
    Occurred 3.5 months after the first dose of EVENITY®1,2,§

AFF = atypical femoral fracture; ONJ = osteonecrosis of the jaw.

*The population for the double-blind safety analysis included all the patients who underwent randomization and received at least one dose of placebo or EVENITY® in the 12-month double-blind period; Occurred in the context of ill-fitting dentures; The events listed include adverse events that were adjudicated as positive by an independent adjudication committee; §The patient had a reported history of prodromal pain at the site of fracture beginning before enrollment.

LEARN MORE ABOUT INTEGRATED SAFETY DATA
(FRAME AND ARCH STUDIES)
EVENITY® VS ALENDRONATE SAFETY EVENITY® VS TERIPARATIDE SAFETY

IMPORTANT SAFETY INFORMATION FOR EVENITY®

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