HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciQuiza is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.

Limitations of Use:

LuciQuiza is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with LuciQuiza in this setting has not been demonstrated.

DOSAGE AND ADMINISTRATION

· Take LuciQuiza tablets orally once daily with or without food at approximately the same time each day.

· See Full Prescribing Information for recommended LuciQuiza dosage regimen and dosage modifications.

DOSAGE FORMS AND STRENGTHS

Tablets: 26.5mg×14 tablets.

CONTRAINDICATIONS

Contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes.

WARNINGS AND PRECAUTIONS

· QT Prolongation, Torsades de Pointes, and Cardiac Arrest: Monitor electrocardiograms and levels of serum electrolytes. Reduce, interrupt, or permanently discontinue LuciQuiza as appropriate.

· Embryo-Fetal Toxicity: LuciQuiza can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (>20%) adverse reactions, including laboratory abnormalities, are lymphocytes decreased, potassium decreased, albumin decreased, phosphorus decreased, alkaline phosphatase increased, magnesium decreased, febrile neutropenia, diarrhea, mucositis, nausea, calcium decreased, abdominal pain, sepsis, neutropenia, headache, creatine phosphokinase increased, vomiting, and upper respiratory tract infection.

DRUG INTERACTIONS

• Strong CYP3A Inhibitors: Reduce the LuciQuiza dose.

• Strong or Moderate CYP3A Inducers: Avoid concomitant use.

USE IN SPECIFIC POPULATIONS

Lactation: Advise 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.