Lazcluze Dosage

Generic name: LAZERTINIB 240mg
Dosage form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on Aug 20, 2024.

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 [see Clinical Studies (14)] . 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

The recommended dosage of LAZCLUZE is 240 mg orally once daily administered in combination with amivantamab with or without food. Swallow LAZCLUZE tablets whole. Do not crush, split, or chew. Continue treatment until disease progression or unacceptable toxicity.

Administer LAZCLUZE any time prior to amivantamab when given on the same day. Refer to the amivantamab prescribing information for recommended amivantamab dosing information.

Missed Dose

If a patient misses a dose of LAZCLUZE within 12 hours, instruct patients to take the missed dose. If more than 12 hours has passed since the dose was to be given, instruct the patient to take the next dose at its scheduled time.

Vomiting

If vomiting occurs any time after taking LAZCLUZE, instruct the patient to take the next dose at its next regularly scheduled time.

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 [see Warnings and Precautions (5.1)]. 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 [see Warnings and Precautions (5.3)]. 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.

Table 1: Recommended Dose Reductions for Adverse Reactions for LAZCLUZE
Dose at which the adverse reaction occurred	1 stDose Reduction	2 ndDose Reduction	3 rdDose Reduction
240 mg once daily (one 240 mg tablet)	160 mg once daily (two 80 mg tablets)	80 mg once daily (one 80 mg tablet)	Discontinue LAZCLUZE

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.

Table 2: Recommended Management and Dosage Modifications for Adverse Reactions
Adverse Reaction	Severity	Dosage Modification
Venous Thromboembolic Events (VTE) [see Warnings and Precautions (5.1)]	Grade 2 or 3	Withhold LAZCLUZE and amivantamab. Administer anticoagulant treatment as clinically indicated. Once anticoagulant treatment has been initiated, resume LAZCLUZE and amivantamab at the same dose level, at the discretion of the healthcare provider.
	Grade 4 or recurrent Grade 2 or 3 despite therapeutic level anticoagulation	Withhold LAZCLUZE and permanently discontinue amivantamab. Administer anticoagulant treatment as clinically indicated. Once anticoagulant treatment has been initiated, treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider.
Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.2)]	Any Grade	Withhold LAZCLUZE and amivantamab if ILD/pneumonitis is suspected. Permanently discontinue LAZCLUZE and amivantamab if ILD/pneumonitis is confirmed.
Dermatologic Adverse Reactions (including dermatitis acneiform, pruritus, dry skin) [see Warnings and Precautions (5.3)]	Grade 1	Initiate supportive care management.
	Grade 2	Initiate supportive care management. If there is no improvement after 2 weeks, reduce amivantamab dose and continue LAZCLUZE at the same dose. Reassess every 2 weeks, if no improvement, reduce LAZCLUZE dose until ≤ Grade 1 (Table 1), then may resume previous dose of LAZCLUZE at the discretion of the healthcare provider.
	Grade 3	Withhold LAZCLUZE and amivantamab. Initiate supportive care management. Upon recovery to ≤ Grade 2, resume LAZCLUZE at the same dose or consider dose reduction, resume amivantamab at a reduced dose. If there is no improvement within 2 weeks, permanently discontinue both LAZCLUZE and amivantamab.
	Grade 4 (including severe bullous, blistering or exfoliating skin conditions)	Initiate supportive care management. Permanently discontinue amivantamab. Withhold LAZCLUZE until recovery ≤ Grade 2 or baseline. Upon recovery to ≤ Grade 2, resume LAZCLUZE at a reduced dose at the discretion of the healthcare provider.
Other Adverse Reactions [see Adverse Reactions (6.1)]	Grade 3–4	Withhold LAZCLUZE and amivantamab until the adverse reaction resolves to ≤ Grade 1 or baseline. Resume both drugs at a reduced dose or LAZCLUZE alone. Consider permanently discontinuing both LAZCLUZE and amivantamab if recovery does not occur within 4 weeks.