Romosozumab

EVENITY is a sclerostin inhibitor 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. Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.

EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength.

Two separate subcutaneous injections are needed to administer the total dose of 210 mg. Inject two syringes, one after the other. Should be administered by a healthcare provider. Administer 210 mg subcutaneously once every month for 12 doses in the abdomen, thigh, or upper arm. Adequately supplement calcium and vitamin D during treatment.

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-aqqg or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria. Hypocalcemia. Known hypersensitivity to EVENITY

Boxed warning (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. Major Adverse Cardiac Events (MACE): Monitor for symptoms of MI and stroke and seek prompt medical attention if symptoms occur. Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria. Discontinue EVENITY if a clinically significant allergic reaction occurs. Hypocalcemia: Adequately supplement calcium and vitamin D during treatment with EVENITY. Osteonecrosis of the Jaw: Monitor for symptoms.

The following adverse reactions are discussed in greater detail in other sections of the label: Major adverse cardiac events Hypersensitivity Hypocalcemia Osteonecrosis of the Jaw Atypical Subtrochanteric and Diaphyseal Femoral Fractures The most common adverse reactions (≥ 5%) reported with EVENITY in clinical trials were arthralgia and headache.

Refrigerate EVENITY at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. If removed from the refrigerator, EVENITY can be kept at room temperature up to 25°C (77°F) in the original carton and must be used within 30 days. Do not expose EVENITY to temperatures above 25°C (77°F). Do not shake.