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

available osteoporosis therapy. 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

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

IMPORTANT SAFETY INFORMATION

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.