Erlotinib LuciErlo Erlotinib150mg 30 tablets exported to China 3% customs value-added tax

Erlotinib Tablets (LuciErlo) Simple Instructions

Please use under the guidance of a physician

Product Name: LuciErlo

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Erlotinib tablets

English name: Erlotinib tablets

Drug approval number: 09 L 1214/24

 

【Indications】

LuciErlo is a kinase inhibitor indicated for:

• For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations as detected by an FDA-approved test, who have progressed after at least one prior chemotherapy regimen and are receiving first-line, maintenance, or second-line or higher therapy.

• In combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Restrictions on Use:

• The safety and effectiveness of LuciErlo have not been established in patients with NSCLC whose tumors have other EGFR mutations.

• LuciErlo is not recommended for use in combination with platinum-based chemotherapy.

 

【Usage and Dosage】

• NSCLC: 150 mg orally, on an empty stomach, once a day.

• Pancreatic cancer: Take 100 mg orally on an empty stomach, once a day.

 

【Specification】

150mg/tablet, 30 tablets/box.

 

【 Contraindications 】

none.

 

【 Warnings and precautions 】

• Interstitial lung disease (ILD): 1.1% of patients develop this disease. Discontinue LuciErlo if new or progressive unexplained pulmonary symptoms (such as dyspnea, cough, and fever) occur. Discontinue LuciErlo if ILD is diagnosed.

• Renal Failure: Monitor renal function and electrolytes, particularly in patients at risk for dehydration. Discontinue LuciErlo if severe renal toxicity occurs.

• Hepatotoxicity: With or without associated hepatic impairment, including hepatic failure and hepatorenal syndrome: Monitor liver function tests regularly. Withhold or discontinue LuciErlo if severe or worsening liver function tests occur.

• Gastrointestinal perforation: Discontinue LuciErlo.

• Bullous and exfoliative dermatoses: Discontinue LuciErlo.

• Cerebrovascular accident (CVA): Patients with pancreatic cancer are at increased risk of CVA.

• Microangiopathic hemolytic anemia (MAHA): Patients with pancreatic cancer are at increased risk of developing MAHA.

• Eye disorders: Discontinue LuciErlo in the event of corneal perforation, ulceration, or persistent severe keratitis.

• Bleeding in patients taking warfarin: Monitor INR regularly in patients taking warfarin or other coumarin-derivative anticoagulants.

• Embryo-fetal toxicity: Can cause fetal harm. Advise females of childbearing potential of the potential risk to the fetus and use effective contraceptive measures.

 

【Adverse Reactions】

Pooled analysis showed that the most common adverse reactions (≥20%) for LuciErlo in patients with NSCLC across all approved treatment lines (regardless of EGFR mutation) and pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting.

 

【Drug Interactions】

• CYP3A4 inhibitors or the combination of CYP3A4 and CYP1A2 inhibitors may increase erlotinib plasma concentrations. Avoid concomitant use. If not possible, reduce the LuciErlo dose.

• CYP3A4 inducers will decrease erlotinib plasma concentrations. Avoid concomitant use. If not possible, increase LuciErlo dose.

• Smoking and CYP1A2 inducers decrease erlotinib plasma concentrations. Avoid concomitant use. If not possible, increase LuciErlo dose.

• Drugs that increase gastric pH will decrease the plasma concentration of erlotinib. For proton pump inhibitors, avoid concomitant use if possible. For H-2 receptor antagonists, take LuciErlo 10 hours after taking the H-2 receptor antagonist. When used with antacids, take them several hours apart.

 

【Use by specific groups】

Lactation: Do not breastfeed.

 

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.