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 TERIPARATIDE (STRUCTURE)

Consider the safety profile of EVENITY™
in this BMD study

Adverse Events1

EVENITY™
(N = 218) n (%)
Teriparatide
(N = 214) n (%)
All adverse events
164 (75)
148 (69)
Adverse events
Nasopharyngitis*
28 (13)
22 (10)
Arthralgia*
22 (10)
13 (6)
Hypercalcemia*
2 (<1)
22 (10)
Injection site reaction
17 (8)
6 (3)
Hypocalcemia
3 (1)
0
Serious adverse event
17 (8)
23 (11)
Leading to discontinuation of investigational product§
6 (3)
12 (6)
Death**
1 (<1)
1 (<1)

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

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

Reported as different types of injection-site reactions with the most frequent as injection-site pain in the EVENITY™ group.

Includes events reported as hypocalcemia and decreased blood calcium concentration.

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

**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.

EVENITY™ VS ALENDRONATE SAFETY EVENITY™ VS PLACEBO 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. 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.