ADVERSE REACTIONS
Reversible renal shutdown has occurred with administration of excessive doses (See " PRECAUTIONS " section).
Phlebitis with or without leucocytosis and with or without mild pyrexia has occurred after administration of hematin through small arm veins.
There have been post-marketing and literature reports of thrombocytopenia and coagulaopathy (including prolonged prothrombin time and prolonged partial thromboplastin time) in patients receiving PANHEMATIN. The initial literature report8 described coagulopathy occurring in a patient receiving hematin therapy. This patient exhibited prolonged prothrombin time and partial thromboplastin time, thrombocytopenia, mild hypofibrogenemia, mild elevation of fibrin split products, and a 10% fall in hematocrit.
|