MONOFERRIC (Iron Isomaltoside 1000 for Injection) 3 Serious Warnings and Precautions Box

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Serious Warnings and Precautions

MONOFERRIC is contraindicated in patients with any allergy to this drug or known serious hypersensitivity to other parenteral iron products.

The following are clinically significant adverse events:

  • Serious hypersensitivity reactions including life threatening and fatal anaphylaxis/anaphylactoid reactions have been reported in patients receiving intravenous iron products including MONOFERRIC (see Immune, Hypersensitivity below).
  • Serious cases of hypotension (see Cardiovascular below).

MONOFERRRIC should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions (see Immune, Hypersensitivity below).

Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each administration of MONOFERRIC.