Recordati Rare Diseases announced the availability of a new 350mg single-vial dosage strength of Panhematin (hemin for injection) to ameliorate recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women. It is intended for use after initial carbohydrate therapy is known or suspected to be inadequate.

Panhematin, a delta-aminolevulinic acid synthetase inhibitor, works by limiting the hepatic and/or marrow synthesis of porphyrin. The exact mechanism by which hematin produces symptomatic improvement in patients with acute episodes of hepatic porphyria has not been established.  

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The new dosage strength better meets the required dose of most patients with AIP. The labeling for Panhematin now includes the new strength as well as clinical data supporting its approval over 30 years ago. Other labeling updates include the removal of the boxed warning and changes to the adverse events section. 

The new 350mg dosage strength is available as a lyophilized black powder in single-dose vials. 

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