LuciGil

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.