HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciZonger is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

DOSAGE AND ADMINISTRATION

• Select patients for treatment with LuciZonger based on the presence of HER2 (ERBB2) tyrosine kinase domain activating mutations.

• The recommended dosage of LuciZonger is based on body weight:

< 90 kg: 120 mg

≥ 90 kg: 180 mg

• Take LuciZonger orally once daily with or without food until disease progression or unacceptable toxicity.

DOSAGE FORMS AND STRENGTHS

Tablets: 60 mg×60 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Hepatotoxicity: Monitor liver function tests including ALT, AST, and total bilirubin at baseline prior to administration, every 2 weeks during the first 12 weeks, and then monthly thereafter as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Interrupt, reduce the dose, or permanently discontinue LuciZonger based on severity.

• Left Ventricular Dysfunction: Before initiating, evaluate LVEF and monitor at regular intervals during treatment and as clinically indicated. Interrupt, reduce the dose, or permanently discontinue LuciZonger based on severity.

• Interstitial Lung Disease/Pneumonitis: Monitor for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Interrupt, reduce the dose, or permanently discontinue LuciZonger based on severity.  

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

ADVERSE REACTIONS

Most common adverse reactions (≥ 20%) are diarrhea, hepatotoxicity, rash, fatigue, and nausea.

The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased alanine aminotransferase, increased aspartate aminotransferase, decreased potassium, and increased gamma glutamyl transferase.

DRUG INTERACTIONS

· Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase LuciZonger dose.

· BCRP Substrates: Avoid concomitant use with certain BCRP substrates where minimal concentration increase may lead to serious adverse reactions and consider alternative therapies. If concomitant use cannot be avoided, monitor patients closely for adverse reactions and follow recommendations provided in the BCRP substrate approved product labeling. For other BCRP substrates, monitor for increased adverse reactions and adjust the dosages of those substrates as clinically appropriate.

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.