So at least with revumenib, which is the FDA approved drug, one of the very important things when you’re giving the drug is you have to be sure that the electrolytes are at normal levels so that the potassium is over four, magnesium over two, because you don’t want to develop complications related to this QTc prolongation. You also have to look for signs and symptoms of differentiation syndrome, weight gain, shortness of breath, renal dysfunction...
So at least with revumenib, which is the FDA approved drug, one of the very important things when you’re giving the drug is you have to be sure that the electrolytes are at normal levels so that the potassium is over four, magnesium over two, because you don’t want to develop complications related to this QTc prolongation. You also have to look for signs and symptoms of differentiation syndrome, weight gain, shortness of breath, renal dysfunction. Those are all things that you have to really worry about a little bit. So you have to monitor these patients very carefully.
For QTc prolongation, the FDA has said that you do an EKG before you start the patient on the medication. If the QTc is less than 450, you can start revumenib. Then you have to monitor EKGs weekly for the first month and then monthly thereafter. So there is some strict monitoring that needs to go on, but with the strict monitoring, we think it’s a safe drug.
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