EVENITY™ (romosozumab injection)
Romosozumab, a sclerostin inhibitor, is the first new approach to the treatment of osteoporosis and fracture risk in almost a decade.
Romosozumab (EVENITY™) significantly and rapidly (over 12 months) increases BMD in both the lumbar spine and total hip, and in both trabecular and cortical bone, leading to an increase in bone strength and reduced risk of fracture. In clinical trials, romosozumab shows better results than other treatments.
Adverse reactions in contrast to other treatments were equally balanced with the exception of cardiovascular events where a slightly increased risk has been shown.
Other EVENITY™ news: Health Canada has provided a Notice of Compliance (NOC) to EVENITY™ (romosozumab) 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.
OSTEOPOROSIS CANADA STATEMENT
Osteoporosis Canada is encouraged to see additional treatments become available for Canadians who are at high risk of fracture from osteoporosis. If you are at high risk of fracture, the benefits of taking a bone drug can outweigh the associated risks. However, a full consultation with your doctor should be conducted prior to starting treatment.
Romosozumab (Sclerostin Inhibitor)
Romosozumab is a new class of osteoporosis treatment, a sclerostin inhibitor that both increases bone formation and decreases bone resorption. Romosozumab (Evenity™) is the first treatment approved by Health Canada in this class.
How Does Romosozumab Work?
Romosozumab increases bone mineral density in both the lumbar spine and total hip, and in both trabecular and cortical bone, leading to an increase in bone strength and reduced risk of fracture.
How Effective Is It?
Romosozumab reduces the risk of fractures at the spine, hip and other sites in women with postmenopausal osteoporosis.
How Is It Taken?
Romosozumab is administered as two injections under the skin, 105 mg/1.17mL solution each, one after the other, by a trained healthcare professional once a month for a year (12 doses). If required, an anti-resorptive agent may be considered after completion of Evenity™.
Are There Side Effects?
The most common side effects of Romosozumab are joint pain and headaches. Other potential side effects include increased risk of heart attack, stroke, or death from a cardiovascular problem; low blood calcium levels; osteonecrosis of the jaw; and atypical thigh fractures.