What should I Know Regarding Pregnancy, Nursing and Administering Denosumab Subcutaneous to Children or the Elderly?

If you are pregnant

  • Not Recommended:

    • If you are nursing

  • Precaution: INSUFFICIENT HUMAN DATA AVAILABLE

    • If you are an adult over 60

  • management or monitoring precaution: General-Monitor serum calcium closely. Increased risk of hypocalcemia with creatinine clearance less than 30 mL/min or on dialysis. Supplement calcium and vitamin D as needed. Musculoskeletal-Reports of atypical, pathologic subtrochanteric or proximal diaphyseal fractures can occur with little or no trauma. Caution with drug discontinuation in patients with osteoporosis or prior fractures; may be at risk for multiple vertebral fractures.

    • Pediatric use

  • Severe Precaution: Potential risk of impaired bone growth and tooth development. Limited use for giant cell tumor of bone in skeletally mature adolescents (age 12-16 years)
  • Severe Precaution: Severe hypercalcemia reported in patients with osteogenesis imperfecta. Risk of impaired bone and tooth development. Not approved for pediatric use.
    • Full Drug Information

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.