FDA label cdfd9947-bc51-43c9-9bd0-130c214bb68a

PANHEMATIN (hemin for injection) should only be used by physicians experienced in the management of porphyrias in hospitals where the recommended clinical and laboratory diagnostic and monitoring techniques are available. PANHEMATIN therapy should be considered after an appropriate period of alternate therapy (i.e., 400 g glucose/day for 1 to 2 days). (See " WARNINGS ", " PRECAUTIONS " and " DOSAGE AND ADMINISTRATION " sections.)

WARNINGS PANHEMATIN is made from human blood. Products made from human blood may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening blood donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Recordati Rare Diseases, (1-888-575-8344). The physician should discuss the risks and benefits of this product with the patient. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. PANHEMATIN therapy is intended to limit the rate of porphyria/heme biosynthesis possibly by inhibiting the enzyme δ-aminolevulinic acid synthetase. For this reason, drugs such as estrogens, barbituric acid derivatives and steroid metabolites which increase the activity of δ-aminolevulinic acid synthetase should be avoided. Also, because hemin for injection has exhibited transient, mild anticoagulant effects during clinical studies, concurrent anticoagulant therapy should be avoided.[ 9 ] The extent and duration of the hypocoagulable state induced by PANHEMATIN has not been established.

ADVERSE REACTIONS Clinical Trials Experience Phlebitis with or without leucocytosis and with or without mild pyrexia has occurred after administration of hematin through small arm veins. Post-marketing Experience 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 Recordati Rare Diseases at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.