HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciDela is a kinase inhibitor indicated for the treatment of patients with:  

• Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

Limitations of use:

LuciDela is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas.

LuciDela is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.

DOSAGE AND ADMINISTRATION

Recommended dosage: 150 mg orally twice daily.

DOSAGE FORMS AND STRENGTHS

Tablets: 150 mg×60 tablets

CONTRAINDICATIONS

History of serious hypersensitivity reactions to idelalisib, including anaphylaxis, or history of toxic epidermal necrolysis with any drug.

WARNINGS AND PRECAUTIONS

• Severe Cutaneous Reactions: Monitor patients for the development of severe cutaneous reactions. Permanently discontinue LuciDela if confirmed.

• Hypersensitivity Reactions: Permanently discontinue LuciDela and institute appropriate supportive measures.

• Neutropenia: Monitor blood counts. Interrupt LuciDela until resolution and resume at reduced dose.  

• Embryo-fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

• The most common adverse reactions (incidence ≥30%) in patients treated with LuciDela in combination trials are diarrhea, pneumonia, pyrexia, fatigue, rash, cough, and nausea.

• Common laboratory abnormalities are neutropenia, ALT elevations and AST elevations.

DRUG INTERACTIONS

• Strong CYP3A Inhibitors: Additional monitoring required if alternative therapy is not available.

• Strong CYP3A Inducers: Avoid coadministration of strong CYP3A inducers.

• CYP3A Substrates: Avoid coadministration of sensitive CYP3A substrates.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

Storage

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