Boxed Warning: Anaphylaxis

 

Boxed Warning: Anaphylaxis

  • Anaphylaxis has occurred with MEPSEVII administration, as early as the first 
dose, therefore appropriate medical support should be readily available when MEPSEVII is administered.
  • Closely observe patients during and for 60 minutes after MEPSEVII infusion.
  • Immediately discontinue the MEPSEVII infusion if the patient experiences anaphylaxis.
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  • Anaphylaxis has occurred with MEPSEVII administration, as early as the first 
dose, therefore appropriate medical support should be readily available when MEPSEVII is administered.
  • Closely observe patients during and for 60 minutes after MEPSEVII infusion.
  • Immediately discontinue the MEPSEVII infusion if the patient experiences anaphylaxis.

  • Anaphylaxis to MEPSEVII was reported in 2 of 20 patients in the clinical program. The two patients with anaphylaxis to MEPSEVII during the clinical trials had one occurrence each and tolerated subsequent infusions of MEPSEVII, without recurrence.
  • Consider the risks and benefits of re-administering MEPSEVII following anaphylaxis.
  • Manifestations included respiratory distress, cyanosis, decreased oxygen saturation, and hypotension.
  • Prior to discharge, inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care if symptoms occur.
 

  • Anaphylaxis to MEPSEVII was reported in 2 of 20 patients in the clinical program. The two patients with anaphylaxis to MEPSEVII during the clinical trials had one occurrence each and tolerated subsequent infusions of MEPSEVII, without recurrence.
  • Consider the risks and benefits of re-administering MEPSEVII following anaphylaxis.
  • Manifestations included respiratory distress, cyanosis, decreased oxygen saturation, and hypotension.
  • Prior to discharge, inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care if symptoms occur.

Patients should be informed of the signs and symptoms of anaphylaxis

  • Anaphylaxis occurred during infusion with MEPSEVII and was observed as early as the first dose for 1 patient; therefore, appropriate medical support should be readily available when MEPSEVII is administered

  • Patients should be closely observed during and for 60 minutes after infusion with MEPSEVII

  • If the patient experiences anaphylaxis, the infusion with MEPSEVII should be immediately discontinued

  • Manifestations included respiratory distress, cyanosis, decreased oxygen saturation, and hypotension

  • Prior to discharge, patients should be informed of the signs and symptoms of anaphylaxis, and instructed to seek immediate medical care if symptoms occur

  • The risks and benefits of re-administering MEPSEVII following anaphylaxis should be considered