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

EVENITY® VS ALENDRONATE (ARCH)

Consider the safety profile of EVENITY® in the 12-month double-blind period of the head-to-head study vs alendronate1

Major Adverse Cardiac Events (MACE)1,*

During the 12-month double-blind treatment period of the active-controlled trial (ARCH):

  • Myocardial infarction occurred in 16 women (0.8%) in the EVENITY® group and 5 women (0.2%) in the
    alendronate group
  • Stroke occurred in 13 women (0.6%) in the EVENITY® group and 7 women (0.3%) in the alendronate group
  • Cardiovascular death occurred in 17 women (0.8%) in the EVENITY® group and 12 women (0.6%) in the
    alendronate group
  • MACE resulted in incidences of 41 (2.0%) in the EVENITY® group and 22 (1.1%) in the alendronate group
  • ARCH MACE Hazard Ratio: 1.87 [1.11, 3.14] for EVENITY® compared to alendronate

*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.

ADVERSE REACTIONS OCCURRING IN ≥ 2% OF EVENITY®-TREATED WOMEN IN THE DOUBLE-BLIND PORTION OF THE ARCH TRIAL1,*

ARCH
Preferred Term
Alendronate
(N = 2014) n (%)
EVENITY®
(N = 2040) 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)

*Adverse reactions based on occurrence in ≥ 2% of EVENITY®-treated patients in either FRAME or ARCH and a plausible relationship to EVENITY®.

Major Adverse Cardiac Events (MACE)1,*

  • During the 12-month double-blind treatment period of the active-controlled trial (ARCH):
  • Myocardial infarction occurred in 16 women (0.8%) in the EVENITY® group and 5 (0.2%) women in the alendronate group
  • Stroke occurred in 13 women (0.6%) in the EVENITY® group and 7 (0.3%) women in the alendronate group
  • Cardiovascular death occurred in 17 women (0.8%) in the EVENITY® group and 12 (0.6%) women in the alendronate group
  • MACE resulted in incidences of 41 (2.0%) in the EVENITY® group and 22 (1.1%) in the alendronate group
  • ARCH MACE Hazard Ratio: 1.87 [1.11, 3.14] for EVENITY® compared to alendronate

*MACE is a composite endpoint of positively adjudicated Ml, stroke, and CV 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.

CV = cardiovascular; MI = myocardial infarction.

Adjudicated Cases of ONJ & AFF1,2
4054 patients were evaluated during the 12-month treatment period1
  • No adjudicated cases of ONJ2
  • No adjudicated cases of AFF2
LEARN MORE ABOUT INTEGRATED SAFETY DATA
(FRAME AND ARCH STUDIES)
EVENITY® VS PLACEBO 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. 2. Saag KG, Petersen J, Brandi ML, et al. Romosozumb or alendronate for fracture prevention in women with osteoporosis. N Engl J Med. 2017;377:1417-1427.