Erlotinib

Erlotinib Tablets produced by Lucius Pharmaceuticals, as an approved targeted therapy drug, provide patients with a cost-effective treatment option on the basis of ensuring consistent quality and efficacy with the original product.

Active Ingredient

The main active ingredient is erlotinib.

Indications

This product is indicated for adult patients with metastatic non-small cell lung cancer (NSCLC) confirmed to have specific EGFR mutations, as well as adult patients with locally advanced or metastatic pancreatic cancer (to be used in combination with gemcitabine).

Dosage and Administration

Non-small cell lung cancer: The recommended dosage is 150 mg once daily.

Pancreatic cancer: The recommended dosage is 100 mg once daily.

All doses should be taken on an empty stomach.

Reference: Dosage and Administration of Erlotinib

Use in Specific Populations

Women of childbearing age: Effective contraceptive measures must be taken during treatment and for a certain period after discontinuation.

Lactating women: Breastfeeding should be discontinued.

Elderly patients and patients with mild hepatic impairment: Use with caution.

Patients with moderate to severe hepatic impairment: Not recommended.

Overdosage

In case of overdosage, discontinue the drug immediately and initiate symptomatic and supportive treatment.

Storage Conditions

Store the drug in a sealed container at room temperature, out of the reach of children.

Pharmacokinetics

After oral administration, the drug is well absorbed with a time to peak concentration (Tmax) of approximately 4 hours.

It is mainly metabolized by the hepatic CYP3A4 enzyme.

The terminal half-life is approximately 36 hours.

FDA，2016.10