HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciMob is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

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

DOSAGE AND ADMINISTRATION

Recommended Dosage: 160 mg orally once daily, with or without food.

DOSAGE FORMS AND STRENGTHS

Capsules: 40 mg×120 capsules

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

· Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold LuciMob in patients with suspected ILD/pneumonitis and permanently discontinue LuciMob if ILD/pneumonitis is confirmed.

· Cardiac Toxicity: Monitor cardiac function, including left ventricular ejection fraction, at baseline and during treatment. Withhold, resume at reduced dose or permanently discontinue based on severity.

· Diarrhea: Diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Monitor electrolytes and advise patients to start an antidiarrheal agent at first episode of diarrhea and to increase fluid and electrolyte intake. Withhold, reduce the dose, or permanently discontinue LuciMob based on the severity.

· Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception.

ADVERSE REACTIONS

The most common (>20%) adverse reactions are diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased amylase, increased lipase, decreased potassium, decreased hemoglobin, increased creatinine, and decreased magnesium.

DRUG INTERACTIONS

· CYP3A Inhibitors: Avoid concomitant use of LuciMob with strong or moderate CYP3A inhibitors. If concomitant use of a moderate CYP3A inhibitor is unavoidable, reduce the dose of LuciMob.  

· CYP3A Inducers: Avoid concomitant use of LuciMob with strong or moderate CYP3A inducers.

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.