Label Changes for:

Optimark (gadoversetamide) injection and pharmacy bulk package injection

December 2010

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS and WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010

 

BOXED WARNING

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
  • Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
  • Do not administer Optimark to patients with:
  • 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.
  • Do not exceed the recommended Optimark dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration

     

CONTRAINDICATIONS

Optimark is contraindicated in patients with:
  • chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2), or
  • acute kidney injury, or
  • known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.

 

WARNINGS

NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
  • chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2), or
    • acute kidney injury, or
    • known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.
  • 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 disease (GFR < 30 mL/min/1.73m2) as well as patients with acute kidney injury. Do not administer Optimark to these patients. The risk appears…
  • 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…
  • 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. When administering Optimark, do not exceed the…

 

INFORMATION FOR PATIENTS

Inform their physician if they have recently received a GBCA.
  • 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 Optimark 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.

 

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