Romosozumab Disease Interactions

Romosozumab is contraindicated in patients with hypocalcemia. Preexisting hypocalcemia must be corrected prior to initiating therapy. Monitor patients for signs and symptoms of hypocalcemia and adequately supplement them with calcium and vitamin D while on treatment. 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 and should be monitored closely. 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.

Romosozumab may increase the risk of myocardial infarction, stroke, and cardiovascular death, and 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, romosozumab should be discontinued.

Osteonecrosis of the jaw (ONJ), has been reported in patients receiving romosozumab. A routine oral examination should be performed prior to initiation of treatment. Risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, preexisting dental disease or infection, anemia, and coagulopathy, and concomitant use of other drugs associated with ONJ (e.g., chemotherapy, bisphosphonates). Patients requiring invasive dental procedures, require clinical judgment of the treating physician and/or oral surgeon to guide the management plan based on benefit-risk assessment. Patients who are suspected of having or who develop ONJ while on romosozumab treatment, should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of treatment should be considered based on benefit-risk assessment.