Xospata Generic Name & Formulations
Gilteritinib 40mg; tabs.
In adults who have relapsed or refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
Xospata Dosage and Administration
Swallow whole. Take at same time each day. Initially 120mg once daily until disease progression or unacceptable toxicity; treat for a minimum of 6 months to allow time for response. Dose modifications for toxicities: see full labeling.
Xospata Boxed Warnings
Risk of differentiation syndrome (may be fatal); initiate corticosteroids if suspected and monitor until resolved. Discontinue if posterior reversible encephalopathy syndrome (PRES) develops. Monitor ECG prior to initiation, on Days 8 and 15 of Cycle 1, and prior to the start of next 2 cycles; interrupt and reduce dose if QTcF >500msec. Correct hypokalemia or hypomagnesemia prior to and during therapy. Evaluate if pancreatitis develops. Assess blood counts/chemistries including creatine phosphokinase prior to initiation, at least once weekly for the 1st month, once every other week for the 2nd month, and once monthly thereafter. Embryo-fetal toxicity. Advise use of effective contraception during and for ≥6 months (females of reproductive potential) or ≥4 months (males w. female partners) after final dose. Pregnancy: exclude status within 7 days prior to initiation. Nursing mothers: not recommended (during and for 2 months after final dose).
Potentiated by strong CYP3A inhibitors (eg, itraconazole); consider alternatives; if concomitant use necessary, monitor frequently. Antagonized by combined P-gp and strong CYP3A inducers (eg, rifampin); avoid. May reduce efficacy of drugs that target 5HT2B or sigma nonspecific receptors (eg, escitalopram, fluoxetine, sertraline); avoid concomitant use unless necessary. May potentiate other P-gp, BCRP, and OCT1 substrates; reduce dose of these substrates.
Xospata Adverse Reactions
Myalgia/arthralgia, transaminase increased, fatigue/malaise, fever, noninfectious diarrhea, dyspnea, edema, rash, pneumonia, nausea, stomatitis, cough, headache, hypotension, dizziness, vomiting; QT prolongation.
Xospata Clinical Trials
Xospata Patient Counseling