Evenity (romosozumab) is an anti-sclerostin monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.EVENITY (romosozumab-aqqg) injection is a clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-use prefilled syringe.
Each single-use prefilled syringe contains 105 mg of EVENITY in a deliverable volume of 1.17 mL. To deliver a full dose, inject two 105 mg/1.17 mL EVENITY prefilled syringes, one after the other for a total dose of 210 mg.
NDC 55513-880-02: Carton of two 105 mg/1.17 mL single-use prefilled syringes.
The prefilled syringe is not made with natural rubber latex. These highlights do not include all the information needed to use EVENITY safely and effectively. See full prescribing information for EVENITY.
EVENITY� (romosozumab-aqqg) injection, for subcutaneous use
Initial U.S. Approval: 2019
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH
See full prescribing information for complete boxed warning.
� EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. (5.1)
� 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. (5.1)
� If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. (5.1)
INDICATIONS AND USAGE
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. (1)
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. (1.2)
DOSAGE AND ADMINISTRATION
Two separate subcutaneous injections are needed to administer the total dose of 210 mg. Inject two syringes, one after the other. (2.1)
Should be administered by a healthcare provider. (2.1)
Administer 210 mg subcutaneously once every month for 12 doses in the abdomen, thigh, or upper arm. (2.2)
Adequately supplement calcium and vitamin D during treatment. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 105 mg/1.17 mL solution in a single-use prefilled syringe. A full dose of EVENITY requires two single-use prefilled syringes. (3)
Known hypersensitivity to EVENITY (4)
WARNINGS AND PRECAUTIONS
Major Adverse Cardiac Events (MACE): Monitor for symptoms of MI and stroke and seek prompt medical attention if symptoms occur. (5.1)
Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria. Discontinue EVENITY if a clinically significant allergic reaction occurs. (5.2)
Hypocalcemia: Adequately supplement calcium and vitamin D during treatment with EVENITY. (5.3)
Osteonecrosis of the Jaw: Monitor for symptoms. Consider discontinuation of therapy based on benefit-risk assessment. (5.4)
Atypical Femoral Fracture: Evaluate new or unusual thigh, hip, or groin pain to rule out an incomplete femur fracture. (5.5)
The most common adverse reactions (? 5%) reported with EVENITY in clinical trials were arthralgia and headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Renal Impairment: Patients with severe renal impairment or receiving dialysis are at greater risk of developing hypocalcemia. Monitor serum calcium and supplement with calcium and vitamin D. (5.3, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.