Gadavist

PATIENT INFORMATION

Nephrogenic Systemic Fibrosis

Instruct patients to inform their physician if they:

  • Have a history of kidney disease and/or liver disease, or
  • Have recently received a GBCA

GBCAs increase the risk of NSF among patients with impaired elimination of drugs. To counsel patients at risk of NSF:

  • Describe the clinical manifestation 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 Gadavist (gadobutrol) 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.

Common Adverse Reactions

Inform patients that they may experience:

  • Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site
  • Side effects of headache, nausea, abnormal taste and feeling hot

General Precautions

Instruct patients receiving Gadavist (gadobutrol) to inform their physician if they:

  • Are pregnant or breastfeeding
  • Have a history of allergic reaction to contrast media, bronchial asthma or allergic respiratory disorder,
  • Are taking any medications

Last reviewed on RxList: 5/5/2011
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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