LuciDac 45mg

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciDac is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

DOSAGE AND ADMINISTRATION

Recommended Dosage: 45 mg orally once daily with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 45 mg×30 tablets.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Interstitial Lung Disease (ILD): Permanently discontinue LuciDac if ILD is confirmed.

• Diarrhea: Withhold and reduce the dose of LuciDac based on the severity.

• Dermatologic Adverse Reactions: Withhold and reduce the dose of LuciDac based on the severity.

• Embryo-Fetal Toxicity: LuciDac can cause fetal harm. Advise females of reproductive potential to use effective contraception.

ADVERSE REACTIONS

Most common adverse reactions are (incidence >20%) diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

DRUG INTERACTIONS

• Proton Pump Inhibitors (PPIs): Avoid use with LuciDac; use locally-acting antacids or H2-receptor antagonist; administer LuciDac at least 6 hours before or 10 hours after H2-receptor antagonist.

• CYP2D6 Substrates: Avoid concomitant use with LuciDac where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

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.