Discontinuation of EVENITY ® should be considered based on benefit-risk assessment.Ītypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY ®. In these patients, dental surgery to treat ONJ may exacerbate the condition. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.įor patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY ®. Osteonecrosis of the Jaw (ONJ): 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 ®. Adequately supplement patients with calcium and vitamin D while on EVENITY ®. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Correct hypocalcemia prior to initiating EVENITY ®. Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY ®. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY ®. Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY ®-treated patients. Reactions have included angioedema, erythema multiforme, and urticaria. EVENITY ® is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY ®.
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In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY ® compared to those treated with alendronate.Ĭontraindications: EVENITY ® is contraindicated in patients with hypocalcemia. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY ® should be discontinued.
Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. EVENITY ® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATHĮVENITY ® may increase the risk of myocardial infarction, stroke and cardiovascular death. IMPORTANT SAFETY INFORMATION FOR EVENITY ®
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