Drug Interaction Report

MONITOR: Coadministration of romosozumab with bisphosphonates, denosumab, angiogenesis inhibitors, or corticosteroids may increase the risk of developing osteonecrosis of the jaw (ONJ). The condition can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing. Other risk factors for ONJ include cancer, chemotherapy, radiotherapy to the head and neck, poor oral hygiene, preexisting dental disease or infection, anemia, and coagulopathy.

MANAGEMENT: Caution is advised when romosozumab is used with other agents that are also associated with osteonecrosis of the jaw. A routine oral examination should be performed by the prescriber prior to initiation of romosozumab treatment. For patients requiring invasive dental procedures, clinical judgment and risk-benefit assessment should guide the management plan of each patient based on their clinical circumstances. Patients should be advised to seek medical attention if they experience signs and symptoms of ONJ, such as: pain in the mouth, teeth, or jaw; swelling or sores inside the mouth; numbness or a feeling of heaviness in the jaw; loosening of a tooth; or exposure of bone in the jaw. Those who are suspected of having or who develop ONJ during romosozumab therapy should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of romosozumab should be considered based on benefit-risk assessment.