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First Adult Injection in US of Dotarem® (gadoterate meglumine) Performed at Winthrop-University Hospital in New York
Date:9/5/2013

gs and Precautions (5.4)].

17 PATIENT COUNSELING INFORMATION

17.1 Nephrogenic Systemic Fibrosis
Instruct patients to inform their healthcare provider if they:

  • have a history of kidney disease, or
  • 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 DOTAREM 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.

17.2 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.

17.3 General Precautions
Instruct patients receiving DOTAREM to inform their physician if they:

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

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Pre-filled syringes manufactured by Catalent, Belgium for Guerbet
Vials manufactured by Recipharm, France for Guerbet

GU06131043
Revised 06/2013

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