FDA Approves Updated ONJ Warning for Prolia, Xgeva

The updated tatement has been added to the ONJ section under Warnings and Precautions
The updated tatement has been added to the ONJ section under Warnings and Precautions

The Food and Drug Administration (FDA) has approved supplemental Biologics License Applications (sBLA) for Amgen's Prolia (denosumab) and Xgeva (denosumab). 

The proposed sBLA includes the addition that the risk of osteonecrosis of the jaw (ONJ) may increase with duration of exposure. This statement has been added to the ONJ section under Warnings and Precautions. In general, a routine oral exam should be performed prior to initiating treatment. A dental exam with preventive dentistry is recommended especially in patients with risk factors for ONJ such as invasive dental procedures, cancer, concomitant therapies (eg, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and certain comorbid disorders. 

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Prolia and Xgeva are both RANK ligand (RANKL) inhibitors. Prolia is indicated in postmenopausal women with osteoporosis and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. It is also approved to increase bone mass in men with osteoporosis at high risk for fracture and in those receiving androgen deprivation therapy for nonmetastatic prostate cancer.

Xgeva is indicated for the treatment of adults and skeletally-mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; the prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors; and the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Prolia is available as 60mg/mL strength solution for subcutaneous (SC) injection. Xgeva is available as 120mg/vial (70mg/mL) strength solution for SC injection.

For more information call (800) 772-6436 or visit Xgeva.com or Prolia.com.

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