Xospata Special Precautions

Differentiation Syndrome: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms and other clinical findings of differentiation syndrome in patients treated with gilteritinib included fever, dyspnea, pleural effusion, pericardial effusion, pulmonary edema, hypotension, rapid weight gain, peripheral edema, rash, and renal dysfunction. Some cases had concomitant acute febrile neutrophilic dermatosis. Differentiation syndrome occurred as early as 1 day and up to 82 days after Xospata initiation and has been observed with or without concomitant leukocytosis.
If differentiation syndrome is suspected, initiate corticosteroids and hemodynamic monitoring until improvement. Taper corticosteroids after resolution of symptoms. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment.
If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt Xospata until signs and symptoms are no longer severe (see Dosage & Administration).
Posterior Reversible Encephalopathy Syndrome: There have been reports of posterior reversible encephalopathy syndrome (PRES) with symptoms including seizure and altered mental status. Symptoms have resolved after discontinuation of Xospata. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue Xospata in patients who develop PRES.
Prolonged QT interval: Xospata has been associated with prolonged cardiac ventricular repolarization (QT Interval) (see PHARMACOLOGY: Pharmacokinetics under Actions). Interrupt and/or reduce the dose of Xospata in patients who have a QTcF >500 msec (see Dosage & Administration and PHARMACOLOGY: Pharmacodynamics under Actions).
Hypokalemia or hypomagnesemia may increase the QT prolongation risk. Correct hypokalemia or hypomagnesemia prior to and during Xospata administration.
Pancreatitis: There have been reports of pancreatitis; however, an association with Xospata has not been confirmed. Evaluate and monitor patients who develop signs and symptoms suggestive of pancreatitis.
Effects on ability to drive and use machines: Xospata has the potential to influence the ability to drive and use machines. Dizziness has been reported in patients taking Xospata and should be considered when assessing a patient's ability to drive or use machines.