Lazcluze Dosage

Patient Selection

Select patients for the first-line treatment of NSCLC with LAZCLUZE, in combination with amivantamab, based on the presence of EGFR exon 19 deletions or exon 21 L858R substitution mutations in tumor or plasma specimens . If these mutations are not detected in a plasma specimen, test tumor tissue. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage and Administration

Concomitant Medications

When initiating treatment with LAZCLUZE in combination with amivantamab, administer anticoagulant prophylaxis to prevent venous thromboembolic events (VTE) for the first four months of treatment. If there are no signs or symptoms of VTE during the first four months of treatment, consider discontinuation of anticoagulant prophylaxis at the discretion of the healthcare provider.

When initiating treatment with LAZCLUZE in combination with amivantamab, administer alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream and encourage patients to limit sun exposure during and for 2 months after treatment, to wear protective clothing and use broad-spectrum UVA/UVB sunscreen to reduce the risk of dermatologic adverse reactions. Consider prophylactic measures (e.g., use of oral antibiotics) to reduce the risk of dermatologic adverse reactions.

Dosage Modifications for Adverse Reactions

The recommended LAZCLUZE dose reductions for adverse reactions are presented in Table 1.

The recommended management and dosage modifications of LAZCLUZE for specific adverse reactions are presented in Table 2. Refer to the amivantamab prescribing information for information about dosage modifications for amivantamab.