What is Romosozumab
Romosozumab is a parenteral humanized IgG2 monoclonal antibody and sclerostin inhibitor.
Romosozumab (Evenity) is an anabolic agent that was FDA approved in 2019. It is a humanized monoclonal antibody directed against sclerostin, a protein produced by osteocytes that is a natural inhibitor of the Wnt pathway; Wnt is the major signaling cascade that stimulates osteoblastic bone formation. Blocking sclerostin results in stimulation of Wnt regulated bone formation. Romosozumab has been shown to increase BMD in women with postmenopausal osteoporosis by 11.3% in the lumbar spine compared with alendronate (4.1% increase), and teriparatide (7.1% increase); total hip and femoral neck BMD also increased significantly. Subsequently, romosozumab was shown in one study of 7180 postmenopausal women with osteoporosis by DEXA criteria, to decrease incident radiographic vertebral fractures by 73% (12 month risk ratio [RR] 0.27, 95% CI 0.16-0.47) in 12 months with a non-significant reduction in non-vertebral fractures (hazard ratio 0.75, 95% CI 0.53-1.05) compared to placebo. In another study of 4093 women with postmenopausal osteoporosis and previous fragility fractures treated with romosozumab or alendronate for 24 months, incident radiographic vertebral fractures were reduced by 48% (RR 0.52, 95% CI 0.40-0.66); nonvertebral fractures and hip fractures were also lower in romosozumab treated patients compared to alendronate treated patients.
Romosozumab has a dual effect of increasing bone formation and, to a lesser extent, decreasing bone resorption.
The drug is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
Guidelines also generally limit the use of agents such as romosozumab for postmenopausal women with a previous history of fractures, a high risk of fractures, or intolerance to or failure of other osteoporosis therapy.
For the treatment of osteoporosis in postmenopausal women at high risk for fracture
- antibody formation
- bone fractures
- erythema multiforme
- injection site reaction
- myocardial infarction
- peripheral edema
The most common adverse reactions (≥ 5%) reported with romosozumab have been arthralgias, headaches and injection site reactions. In one study, romosozumab treated patients experienced serious cardiovascular outcomes (cardiac ischemic and cerebrovascular accidents); investigators acknowledged that additional studies are needed to probe this issue. All prescribing providers should read the FDA label regarding cardiovascular precautions in patient treated with this drug. Occasional hypocalcemia following romosozumab administration was reported in the clinical trials. Both ONJ and AFF have also been reported in patients treated with romosozumab.
- serum calcium
- corticosteroid therapy
- dental disease
- dental work
- myocardial infarction
- radiation therapy
- renal failure
- renal impairment
There are no drug interactions associated with Romosozumab products.
Romosozumab is given by health care professionals (infusion center or physician office) by subcutaneous (SQ) injections, 210 mg SQ (requires two injections of 105 mg/1.17 mL single-use prefilled syringes) every month for 12 months.