onse rate. *CR was defined as an absolute neutrophil count ≥1.0 x 109/L, platelets ≥100 x 109/L, normal marrow differential with <5%blasts, must have been red blood cells, platelet transfusion independent and no evidence of extramedullary leukemia.
†CRh was defined as marrow blasts <5%, partial hematologic recovery absolute neutrophil count ≥0.5 x 109/L and platelets
≥50 x 109/L, no evidence of extramedullary leukemia and could not have been classified as CR.
‡The 95% CI rate was calculated using the exact method based on binomial distribution.
§DOR was defined as the time from the date of either first CR or CRh until the date of a documented relapse of any type.
Deaths were counted as events.
Response was ongoing.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
XOSPATA (gilteritinib) 40 mg tablets are supplied as light yellow, round-shaped, film-coated tablets debossed with theAstellas logo and ‘235’ on the same side. XOSPATA tablets are available in the following package size:
• Bottles of 90 tablets with Child Resistant Closure, (NDC 0469-1425-90)
16.2 Storage
Store XOSPATA tablets at 20ºC to 25ºC (68°F to 77°F); excursions permitted between 15ºC to 30ºC (59°F to 86°F) [SeeUSP Controlled Room Temperature]. Keep in original container.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Posterior Reversible Encephalopathy Syndrome
Advise patients of the risk of developing posterior reversible encephalopathy syndrome (PRES). Ask patients toimmediately report any symptoms suggestive of PRES, such as seizure and altered mental status, to their healthcareprovider for further eva luation [see Warnings and Precautions (5.1)].
Prolonged QT Interval
Advise patients to consult their healthcare provider immediately if they feel faint, lose consciousness, or have signs orsymptoms suggestive of arrhythmia. Advise patients with a history of hypokalemia or hypomagnesemia of the importanceof monitoring their electrolytes [see Warnings and Precautions (5.2)].
Pancreatitis
Advise patients of the risk of pancreatitis and to contact their healthcare provider for signs or symptoms of pancreatitis,
which include severe and persistent stomach pain, with or without nausea and vomiting [see Warnings and Precautions
(5.3)].
Use of Contraceptives
•Advise female patients with reproductive potential to use effective contraceptive methods while receiving XOSPATA and to avoid pregnancy while on treatment and for 6 months after completion of treatment.
•Advise patients to notify their healthcare provider immediately in the event of a pregnancy or if pregnancy issuspected during XOSPATA treatment.
•Advise males with female partners of reproductive potential to use effective contraception during treatment withXOSPATA and for at least 4 months after the last dose of XOSPATA [see Use in Specific Populations (8.3)].
Lactation
Advise women not to breastfeed during treatment with XOSPATA for at least 2 months after the final dose [see Use inSpecific Populations (8.2)].
Dosing Instructions
•Advise patients not to break, crush or chew the tablets but to swallow them whole with a cup of water.
•Instruct patients that, if they miss a dose of XOSPATA, to take it as soon as po
