HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useEVENITY safely and effectively. See full prescribing information forEVENITY.
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, strokeand cardiovascular death. (5.1)
• EVENITY should not be initiated in patients who have had amyocardial infarction or stroke within the preceding year. Considerwhether the benefits outweigh the risks in patients with othercardiovascular risk factors. (5.1)
• If a patient experiences a myocardial infarction or stroke duringtherapy, EVENITY should be discontinued. (5.1)
INDICATIONS AND USAGE
EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosisin postmenopausal women at high risk for fracture, defined as a history ofosteoporotic fracture, or multiple risk factors for fracture; or patients whohave failed or are intolerant to other available osteoporosis therapy. (1)
Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosistherapy remains warranted, continued therapy with an anti-resorptive agentshould be considered. (1.2)
DOSAGE AND ADMINISTRATION
• Two separate subcutaneous injections are needed to administer the totaldose 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 theabdomen, 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 fulldose of EVENITY requires two single-use prefilled syringes. (3)
CONTRAINDICATIONS
• Hypocalcemia (4)
• Known hypersensitivity to EVENITY (4)
WARNINGS AND PRECAUTIONS
• Major Adverse Cardiac Events (MACE): Monitor for symptoms of MIand stroke and seek prompt medical attention if symptoms occur. (5.1)
• Hypersensitivity: Hypersensitivity reactions, including angioedema,erythema multiforme, dermatitis, rash, and urticaria. DiscontinueEVENITY if a clinically significant allergic reaction occurs. (5.2)
• Hypocalcemia: Adequately supplement calcium and vitamin D duringtreatment with EVENITY. (5.3)
• Osteonecrosis of the Jaw: Monitor for symptoms. Considerdiscontinuation of therapy based on benefit-risk assessment. (5.4)
• Atypical Femoral Fracture: eva luate new or unusual thigh, hip, or groinpain to rule out an incomplete femur fracture. (5.5)
ADVERSE REACTIONS
The most common adverse reactions (≥ 5%) reported with EVENITY inclinical trials were arthralgia and headache. (6.1)
USE IN SPECIFIC POPULATIONS
Renal Impairment: Patients with severe renal impairment or receiving dialysisare at greater risk of developing hypocalcemia. Monitor serum calcium andsupplement with calcium and vitamin D. (5.3, 8.7)
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised