Clinical Trials Experience
Phlebitis with or without leucocytosis and with or without mild pyrexia has occurred after administration of hematin through small arm veins.
Reversible renal shutdown has occurred with administration of excessive doses (See “PRECAUTIONS” section).
There have been post-marketing literature reports of thrombocytopenia and coagulopathy (including prolonged prothrombin time and prolonged partial thromboplastin time) in patients receiving PANHEMATIN.8 Iron overload and serum ferritin increased have also been reported (See “PRECAUTIONS” section).
To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.