- Approval Id
- 85e5dc21e6ee12dd
- Drug Name
- LAZCLUZE FILM-COATED TABLETS 80MG
- Product Name
- LAZCLUZE FILM-COATED TABLETS 80MG
- Approval Number
- SIN17349P
- Approval Date
- 2025-10-02
- Registrant
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
- Licence Holder
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><strong>Dosage (≥ 18 years)</strong></p>
<p>The recommended dosage of LAZCLUZE® is 240 mg orally once daily in combination with amivantamab until disease progression or no longer tolerated by the patient.</p>
<p>It is recommended to administer LAZCLUZE® any time prior to amivantamab when given on the same day. Refer to the amivantamab prescribing information for recommended amivantamab dosing information.</p>
<p><strong>Missed dose(s)</strong></p>
<p>If a dose of LAZCLUZE® is missed, it can be administered within 12 hours. If more than 12 hours have passed since the dose was to be given, do <strong>not</strong> administer the missed dose and administer the next dose per the usual dosing schedule.</p>
<p><strong>Dose modifications</strong></p>
<p>The recommended dose reductions for adverse reactions are presented in Table 1.</p>
<img src="/TGIF/Lazcluze-Table1.png" alt="Lazcluze Dosage Table 1" /><br><br>
<p>Dose modifications for specific adverse reactions are presented in Table 2.</p>
<p>Refer to the amivantamab prescribing information for information about dose modifications for amivantamab.</p>
<img src="/TGIF/Lazcluze-Table2.png" alt="Lazcluze Dosage Table 2" /><br><br>
<p><strong>Special populations</strong></p>
<p><em><strong>Pediatrics (17 years of age and younger)</strong></em></p>
<p>The safety and efficacy of LAZCLUZE® have not been established in pediatric patients.</p>
<p><em><strong>Elderly (65 years of age and older)</strong></em></p>
<p>Among 421 patients with non-small cell lung cancer treated with LAZCLUZE® in combination with amivantamab in NSC3003, 44.7% were 65 years and older and 11.6% were 75 years and older.</p>
<p>No overall differences in safety or effectiveness were observed as a function of age. No dose adjustment based on age is required (see <em>Pharmacokinetic Properties</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong><em>Renal impairment</em></strong></p>
<p>No formal studies of lazertinib in patients with renal impairment have been conducted.</p>
<p>No dose adjustment is required for patients with mild or moderate renal impairment. LAZCLUZE® has not been studied in patients with severe renal impairment or end-stage renal disease (see <em>Pharmacokinetic Properties</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em><strong>Hepatic impairment</strong></em></p>
<p>No dose adjustment is required for patients with mild or moderate hepatic impairment. The PK of lazertinib in patients with severe hepatic impairment is unknown (see <em>Pharmacokinetic Properties</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Administration</strong></p>
<p>This medicinal product is for oral use. Swallow tablets whole with or without food. Do not crush, split, or chew the tablet.</p>
<p>If vomiting occurs any time after taking LAZCLUZE®, take the next dose the next day.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p>LAZCLUZE® in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Hypersensitivity to the active substance(s) or to any of the excipients.</p>
