HIGHLIGHTS OF PRESCRIBING INFORMATION 

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

INDICATIONS AND USAGE

LuciTaze is a methyltransferase inhibitor indicated for the treatment of: 

• Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. 

• Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. 

• Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

DOSAGE AND ADMINISTRATION 

• Recommended dosage is 800 mg taken orally twice daily with or without food. 

DOSAGE FORMS AND STRENGTHS 

Tablets: 200 mg×56 tablets

CONTRAINDICATIONS 

None.

WARNINGS AND PRECAUTIONS 

• Secondary Malignancies: LuciTaze increases the risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia. Monitor patients long-term for the development of secondary malignancies.

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective non-hormonal contraception. 

ADVERSE REACTIONS 

• The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting, and constipation.

• The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain. 

DRUG INTERACTIONS 

• Strong and Moderate Cytochrome P450 (CYP)3A Inhibitors: Avoid coadministration of strong and moderate CYP3A inhibitors with LuciTaze. Reduce the dose of LuciTaze if coadministration of moderate CYP3A inhibitors cannot be avoided. 

• Strong and Moderate CYP3A Inducers: Avoid coadministration with LuciTaze. 

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.