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

The data from the trials demonstrate a generally favorable benefit-risk profile over the duration of the clinical studies of EVENITY™ followed by an antiresorptive.1

Safety data for two phase 3 studies are included in the EVENITY™ Prescribing Information:

  • EVENITY™ vs placebo (FRAME)
  • EVENITY™ vs alendronate (ARCH)

Subject incidence of Major Adverse Cardiac Events (MACE) in the 12-month double-blind portion of FRAME and ARCH1

SUBJECT INCIDENCE THROUGH MONTH 12

FRAME
Placebo
(N = 3576) n (%)
EVENITY™
(N = 3581) n (%)
MACE
29 (0.8)
30 (0.8)
Myocardial infarction*
8 (0.2)
9 (0.3)
Stroke*
10 (0.3)
8 (0.2)
Cardiovascular death
15 (0.4)
17 (0.5)
ARCH
Alendronate
(N = 2014) n (%)
EVENITY™
(N = 2014) n (%)
MACE
22 (1.1)
41 (2.0)
Myocardial infarction*
5 (0.2)
16 (0.8)
Stroke*
7 (0.3)
13 (0.6)
Cardiovascular death
12 (0.6)
17 (0.8)

MACE is a composite endpoint of positively adjudicated MI, stroke, and CV death.

  • FRAME MACE Hazard Ratio: 1.03 ([0.62, 1.72]) for EVENITY™ compared to placebo
  • ARCH MACE Hazard Ratio: 1.87 ([1.11, 3.14]) for EVENITY™ compared to alendronate

There was a higher rate of MACE in ARCH, but no imbalance was observed in FRAME.

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

†Includes fatal events adjudicated as CV related or undetermined.

CV = cardiovascular; MI = myocardial infarction.

Integrated Safety: Adverse Reactions Occurring in ≥ 2% of EVENITY™-treated Women in at Least One Study1

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)
ARCH
Preferred Term
Alendronate
(N = 2014) n (%)
EVENITY™
(N = 2014) n (%)
Arthralgia
194 (9.6)
166 (8.1)
Headache
110 (5.5)
106 (5.2)
Muscle spasms
81 (4.0)
70 (3.4)
Edema peripheral
38 (1.9)
34 (1.7)
Asthenia
53 (2.6)
50 (2.5)
Neck pain
42 (2.1)
34 (1.7)
Insomnia
36 (1.8)
34 (1.7)
Paresthesia
34 (1.7)
29 (1.4)

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.