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U.S. Department of Health and Human Services

Safety

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Xgeva (denosumab) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –

 

June 2014

Summary View

WARNINGS AND PRECAUTIONS

  • ….An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake [see Adverse Reactions (6.1), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
     

 

August 2013

Summary View 

CONTRAINDICATIONS

Hypocalcemia
  • Pre-existing hypocalcemia must be corrected prior to initiating therapy with Xgeva.
Hypersensitivity
  • Xgeva is contraindicated in patients with known clinically significant hypersensitivity to Xgeva
 

WARNINGS AND PRECAUTIONS

Drug Product with Same Active Ingredient
  • Xgeva includes the same active ingredient (denosumab) found in Prolia. Patients receiving Xgeva should not take Prolia.
Hypersensitivity
  • Clinically significant hypersensitivity including anaphylaxis has been reported with use of Xgeva. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritis, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue Xgeva therapy permanently.
Atypical Subtrochanteric and Diaphyseal Femoral Fracture
  • Atypical femoral fracture has been reported with Xgeva…

 

February 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Hypocalcemia
  • Xgeva can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct preexisting hypocalcemia prior to Xgeva treatment. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when Xgeva is administered with other drugs that can also lower calcium levels. Advise patients to contact a healthcare professional for symptoms of hypocalcemia
 

ADVERSE REACTIONS

Postmarketing Experience
  • Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • The following adverse reactions have been identified during post approval use of Xgeva: Hypocalcemia: Severe symptomatic hypocalcemia, including fatal cases.