LUCIENA
LUCIENA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Product details
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LUCIENA safely and effectively. See full prescribing information for LUCIENA.
INDICATIONS AND USAGE
LUCIENA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
DOSAGE AND ADMINISTRATION
100 mg orally once daily until disease progression or unacceptable toxicity .
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg×30 tablets
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: LUCIENA (enasidenib) can cause fetal harm. Advise patients of the potential risk to a fetus and use effective contraception.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite .
DRUG INTERACTIONS
• Certain CYP1A2 and CYP2C19 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information .
• Certain CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information .
• Certain OATP1B1, OATP1B3, and BCRP Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information.
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.
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