HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LUCIGIL safely and effectively. See full prescribing information for LUCIGIL.

INDICATIONS AND USAGE

LUCIGIL is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

DOSAGE AND ADMINISTRATION

120 mg orally once daily.

DOSAGE FORMS AND STRENGTHS

Tablets: 40 mg×90 tablets

CONTRAINDICATIONS

Hypersensitivity to gilteritinib or any of the excipients. Anaphylactic reactions have been observed in clinical trials.

WARNINGS AND PRECAUTIONS

• Posterior reversible encephalopathy syndrome (PRES): Discontinue LUCIGIL in patients who develop PRES.

• Prolonged QT Interval: Interrupt and reduce LUCIGIL dosage in patients who have a QTcF >500 msec. Correct hypokalemia or hypomagnesemia prior to and during LUCIGIL administration.

• Pancreatitis: Interrupt and reduce the dose in patients who develop pancreatitis.

• Embryo-Fetal Toxicity: LUCIGIL can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) were transaminase increased, myalgia/arthralgia, fatigue/malaise, fever, mucositis, edema, rash, noninfectious diarrhea, dyspnea, nausea, cough, constipation, eye disorders, headache, dizziness, hypotension, vomiting, and renal impairment.

DRUG INTERACTIONS

• Combined P-gp and Strong CYP3A Inducers: Avoid concomitant use.

• Strong CYP3A Inhibitors: Consider alternative therapies. If the concomitant use of strong CYP3A inhibitors cannot be avoided, monitor patients more frequently for LUCIGIL adverse reactions.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.