FDA Approves Changes to the Letairis REMS Program

Update on PAH TreatmentsIn August 2013 the FDA (Food and Drug Administration) approved changes to the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program.  Letairis is an oral ERA originally approved by the FDA for treatment of pulmonary arterial hypertension in 2007.  At the time of its initial release all patients were required to register with LEAP (Letairis Education and Access Program) and were required to have monthly blood tests to check liver function.  In addition all female patients of child bearing potential were required to have monthly pregnancy tests.  The FDA removed the monthly LFT (liver function test) requirement in 2011.  As of August 2013 males no longer need to enroll in LEAP and Letairis can be distributed to male patients through a larger network of non-specialty pharmacies.  The annual re-enrollment requirement for all patients has also been dropped.  That’s right, no more frantic phone calls from nurse coordinates needing signatures on your re-enrollment form!  This is great news as there is less paperwork and red tape for patients to receive and continue on this therapy.

Letairis is contraindicated in females who are pregnant as Letairis can cause fetal harm when administered to a pregnant female.  Female patients will still need to register with LEAP, and if of child bearing potential will need monthly pregnancy tests.  A small group of specialty pharmacies will continue to dispense Letairis to female patients.

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