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05/27/21 6:58 PM

#238171 RE: DewDiligence #238169

Gilenya requires a 6 hour first dose observation (FDO) due to potential for symptomatic bradycardia and 2nd degree Mobitz type 2 AV blocks. We had done ours in the practice's infusion suite (onsite) so this was not overly onerous though costly on staff time and poorly reimbursed. Many practices send the patient to a cardiology office or 'approved' urgent cares for this test. Novartis did set up an At Home FDO which helped. Something as simple as a titration reduces the need for the FDO except in special cases (existing cardiac issues). I've initiated about 20 S1PRM patients in the past year and all but one were either Zeposia or Mayzent.

Lab tests (blood) are the same for all S1PRM's and they all require a baseline EKG. Zeposia only requires an ophth eval for patients with uveitis or h/o macular edema (though I also diabetics) while the other ones require before initiation