Indicated for:

Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture:

• 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.

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 anti-resorptive agent should be considered.

Hypocalcemia has occurred in patients receiving EVENITY. Correct hypocalcemia prior to initiating EVENITY. Patients should be adequately supplemented with calcium and vitamin D during treatment with EVENITY.

If the EVENITY dose is missed, administer as soon as it can be rescheduled. Thereafter, EVENITY can be scheduled every month from the date of the last dose.

The recommended subcutaneous injection sites include: the thigh, abdomen, except for a two-inch area right around the navel, and outer area of upper arm.

EVENITY is contraindicated in patients with:

• Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY
• A history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria

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. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.

Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY.

Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m²) or receiving dialysis are at greater risk of developing hypocalcemia. Monitor serum calcium and adequately supplement patients who have severe renal impairment or are receiving dialysis with calcium and vitamin D. Instruct patients with severe renal impairment, including those receiving dialysis, about the symptoms of hypocalcemia and the importance of maintaining calcium levels with adequate calcium and vitamin D supplementation.

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY. A routine oral examination should be performed by the prescriber prior to initiation of EVENITY treatment. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.

For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral
surgeon should guide the management plan of each patient based on benefit-risk assessment. Patients who are suspected of having or who develop ONJ while on EVENITY should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITY should be considered based on benefit-risk assessment.

Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.

Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.

EVENITY is not indicated for use in women of reproductive potential.

GoToSource

• Use in male patients. GoToSource

• Use in premenopausal women. GoToSource

• Glucocorticoid-induced osteoporosis. GoToSource

• Immobilization-induced bone loss, chronic inflammation-induced bone loss, type 2 diabetes bone loss and bone loss associated with multiple myeloma. GoToSource

• Chronic kidney disease osteoporosis. GoToSource

Cardiac ischemic and cerebrovascular events. GoToSource

Atypical femoral fracture and osteonecrosis of the jaw. GoToSource

Nasopharyngitis, constipation, hyperostosis (excessive growth or thickening of bone tissue), injection-site reaction and hypersensitivity. GoToSource

Hypocalcemia (low blood calcium level). GoToSource

No major injury lawsuits reported.