Label Changes for:

MultiHance (gadobenate dimeglumine) injection

September 2011

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

 

September 2011

 

BOXED WARNING

  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

WARNINGS AND PRECAUTIONS

Nephrogenic Systemic Fibrosis (NSF)
  • Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney...
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (e.g., age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.
  • Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug prior to re-administration...

PATIENT COUNSELING INFORMATION

  • GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. To counsel patients at risk for NSF:
    • Describe the clinical manifestations of NSF
    • Describe procedures to screen for the detection of renal impairment
  • Instruct the patients to contact their physician if they develop signs or symptoms of NSF following MultiHance administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.  

 

October 2009

Summary View

 

WARNINGS

Hypersensitivity Reactions

 

  • Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory and/or cutaneous manifestations and ranging from mild to severe.  Some patients experienced circulatory collapse and died. In most cases, initial symptoms occured within minutes of Multihance administration and resolved with prompt emergency treatment.

 

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