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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.2 Osteonecrosis of the Jaw (ONJ)
- In clinical trials in patients with osseous metastasis, 2.2% of patients receiving Xgeva developed ONJ after a median exposure of 13 doses; of these patients, ......
WARNINGS AND PRECAUTIONS
- Xgeva can cause fetal harm when administered to a pregnant woman. Based on findings in animals, Xgeva is expected to result in adverse reproductive effects. In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent peripheral lymph nodes, abnormal bone growth and decreased neonatal growth.
- There are no adequate and well-controlled studies with Xgeva in pregnant women. Women should be advised not to become pregnant when taking Xgeva. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
USE IN SPECIFIC POPULATIONS
Pregnancy Category D
- Xgeva can cause fetal harm when administered to a pregnant woman based on findings in animals. In utero Denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth and decreased neonatal growth…
- It is not known whether Xgeva is excreted into human milk. Measurable concentrations of Denosumab were present in the maternal milk of cynomolgus monkeys up to 1 month after the last dose of Denosumab (≤ 0.5% milk:serum ratio)…
- Xgeva is not recommended in pediatric patients. The safety and effectiveness of Xgeva in pediatric patients have not been established…