Lazcluze (Lazertinib) - Instructions for Lazertinib

1. Name:Lazertinib, lazertinib ( transliteration)

Product name:Lazcluze, Leclaza

2. Indications:

Lazcluze (Lazertinib) - Lazertinib, in combination with amivantamab (Evantumumab), is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 The L858R substitution mutation was detected by a test approved by the U.S. Food and Drug Administration (FDA) .

3. Usage and dosage:

1. Patient selection: Based on the presence of EGFR exon 19 deletion or exon 21 L858R substitution mutation in tumors or plasma specimens, select patients who receive Lazcluze combined with amivantamab for first-line treatment of non-small cell lung cancer. If these mutations are not detected in the plasma specimen, test the tumor tissue.

2. Recommended dosage and usage: The recommended dosage of Lazcluze is 240 mg once daily, combined with amivantamab, and can be taken with or without food. Swallow Lazcluze tablets whole without crushing, splitting or chewing. Continue treatment until disease progression or unacceptable toxicity occurs. If taking amivantamab on the same dayLazcluze can be taken at any time before taking amivantamab.

3. Combination medication: When starting treatment with Lazcluze and amivantamab, use anticoagulant prophylaxis to prevent venous thromboembolic events (VTE) during the first four months of treatment. If there are no signs or symptoms of VTE during the first four months of treatment, anticoagulation prophylaxis may be discontinued at the discretion of the healthcare provider.

When initiating treatment with Lazcluze in combination with amivantamab, use an alcohol-free (e.g., isopropyl alcohol, ethanol-free) moisturizer and encourage patients to use it during and after treatment.Limit sun exposure, wear protective clothing, and use broad-spectrum UVA/UVB sunscreen for 2 months to reduce the risk of adverse skin reactions. Consider preventive measures(such as use of oral antibiotics) to reduce the risk of adverse skin reactions.

4. Dosage adjustment: After patients are treated with Lazcluze, they may experience intolerable adverse reactions. The doctor will adjust the dose of the drug according to the severity of the condition, such as reducing, interrupting or stopping treatment; the initial dose can be reduced to 160mg once a day (Two tablets80 mg tablet); the second dose can be reduced to 80 mg once daily (one tablet80 mg tablet); if the dose of 80 mg once daily cannot be tolerated, the drug needs to be permanently discontinued.

4. Adverse reactions:

In clinical studies of Lazcluze, the most common adverse reactions (≥20%) were rash, nail toxicity, infusion-related reactions (amivantamab), musculoskeletal pain, edema, stomatitis, VTE, and paresthesias Common symptoms, fatigue, diarrhea, constipation, COVID-19, bleeding, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity; the most common grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin, decreased sodium, increased alanine aminotransferase (ALT), decreased potassium, decreased hemoglobin, increased aspartate aminotransferase (AST), increased GGT, and increased magnesium.

5. Supply and storage:

Lazcluze is available as 80 mg, 160 mg tablets and stored at 20°C to 25°C (68°F to 77°F); tolerances are 15°C to 30°C (59°F to 86°F).

6. Taboo:

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7. Mechanism of action:

Lazertinib, the ingredient in Lazcluze, is an epidermal growth factor receptor (EGFR) kinase inhibitor that inhibits EGFR exon 19 deletions and exon 21 L858R substitution mutations at lower concentrations than wild-type EGFR. Lazertinib demonstrated antitumor activity in human non-small cell lung cancer cells and in mouse xenograft models with EGFR exon 19 deletion or EGFR L858R substitution mutation. In a mouse xenograft model of human non-small cell lung cancer harboring the EGFR L858R mutation, combined treatment with lazertinib and amivantamab increased in vivo antitumor activity compared with either agent alone.