Lazertinib Dosage

Medically reviewed by Drugs.com. Last updated on Oct 1, 2024.

Usual Adult Dose for Non-Small Cell Lung Cancer

240 mg orally once a day administered in combination with amivantamab

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Refer to the amivantamab prescribing information for recommended dosing information for that drug.

Use: For the first-line treatment of 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, as detected by an US FDA-approved test

Renal Dose Adjustments

Mild and Moderate Renal Dysfunction (Estimated GFR [eGFR] 30 to 89 mL/min) : No adjustment recommended
Severe Renal Dysfunction and End Stage Renal Disease (eGFR less than 30 mL/min): Data not available

Liver Dose Adjustments

Mild and Moderate Liver Dysfunction: No adjustment recommended
Sever Liver Dysfunction: Data not available

Dose Adjustments

Recommended Dose Reductions for Adverse Reactions:

• First Dose Reduction: 160 mg once a day (two 80 mg tablets)
• Second Dose Reduction: 80 mg once a day (one 80 mg tablet)
• Third Dose Reduction: Discontinue

Venous Thromboembolic Events (VTE)

• Grade 2 or 3:
• Withhold combination treatment
• Administer anticoagulant treatment as clinically indicated
• Once anticoagulant treatment has been initiated, resume combination treatment at the same dose level, at the discretion of the health care provider

• Grade 4 or recurrent grade 2 or 3 despite therapeutic level anticoagulation
• Withhold and permanently discontinue amivantamab
• Administer anticoagulant treatment as clinically indicated
• Once anticoagulant treatment has been initiated, resume treatment with this drug alone at the same dose level, at the discretion of the health care provider

Interstitial Lung Disease (ILD) or Pneumonitis

• Any grade:
• Withhold combination treatment if ILD or pneumonitis is suspected.
• Permanently discontinue combination treatment if diagnosis is confirmed.

Dermatologic Adverse Reactions (including dermatitis acneiform, pruritus, dry skin)

• 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 this drug alone at the same dose.
• Reassess every 2 weeks, if no improvement, reduce this drug's dose until grade 1 or lower, then may resume to previous dose at the discretion of the healthcare provider.
• Grade 3:
• Withhold combination treatment.
• Initiate supportive care management.
• Upon recovery to grade 2 or lower, resume this drug alone at the same dose or consider dose reduction, and resume amivantamab at a reduced dose.
• If there is no improvement within 2 weeks, permanently discontinue both drugs.
• Grade 4 (including severe bullous, blistering, or exfoliating skin conditions):
• Initiate supportive care management.
• Permanently discontinue amivantamab.
• Withhold this drug until recovery to grade 2 or lower or baseline.
• Upon recovery to grade 2 or lower, resume this drug alone at a reduced dose at the discretion of the healthcare provider.

Other Adverse Reactions

• Grade 3 or 4:
• Withhold combination therapy until the adverse reaction resolves to grade 1 or lower or baseline.
• Resume combination therapy at a reduced dose or this drug alone.
• Consider permanent discontinuation of treatment if recovery does not occur within 4 weeks.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take daily dose with or without food.
• Swallow tablets whole, do not crush, split, or chew.
• Take this drug prior to amivantamab when given on the same day.
• If a dose is missed within 12 hours, take the missed dose. If more than 12 hours have passed, take the next dose at the scheduled time.
• If vomiting occurs any time after taking this drug, take the next dose as scheduled.
• When taking with amivantamab, administer anticoagulant prophylaxis to prevent venous thromboembolic events (VTE) for the first 4 months of treatment. Anticoagulant prophylaxis can be discontinued at the discretion of the healthcare provider if no signs or symptoms of VTE occur during the first 4 months.
• When taking with amivantamab, administer alcohol-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 sunscreen.
• Consider prophylactic measures such as oral antibiotics to reduce the risk of dermatologic adverse reactions.

Patient Selection:

• Select patients for the first-line treatment of NSCLC with this drug, 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 US FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.

Storage requirements:

• Store at 20C to 25C (68F to 77F); with excursions permitted between 15C to 30C (59F to 86F).

General:

• To report suspected adverse reactions, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Monitoring:

• For signs and symptoms of VTE
• For new or worsening symptoms of ILD or pneumonitis such as dyspnea, cough, or fever
• For adverse reactions, including signs and symptoms of eye toxicity and skin reactions

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Males and females of reproductive potential should use effective contraception during treatment and for 3 weeks after the last dose. Contact your healthcare provider immediately if you become pregnant during treatment.
• Do not breastfeed during treatment and for 3 weeks after the last dose.
• Limit sun exposure during and for 2 months after treatment, wear protective clothing, and use broad-spectrum sunscreen.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer