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LAZCLUZE is a brand name for Lazertinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
) 4. 1. Dosing Considerations • Before initiation of LAZCLUZE therapy, EGFR mutation-positive status must have been established using a validated test method. • LAZCLUZE is to be used in combination with amivantamab. The recommended dosage of amivantamab is 1050 mg (if body weight < 80 kg) or 1400 mg (if body weight ≥80 kg) administered by intravenous (IV) infusion in 28-day cycles, once weekly for the first 4 weeks (with a split dose on days 1 and 2) and then once every 2 weeks at week 5 onwards.
Refer to the amivantamab product monograph for further information on dosing considerations for amivantamab. 0 LAZCLUZE (lazertinib tablets) Page 5 of 32 • Prophylactic anticoagulation is recommended to be used for the first four months of LAZCLUZE + amivantamab therapy (See 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
2. Recommended Dose and Dosage Adjustment The recommended dosage of LAZCLUZE is 240 mg once daily, taken orally, in combination with amivantamab until disease progression or no longer tolerated by the patient. It is recommended to administer LAZCLUZE any time prior to amivantamab when given on the same day.
The recommended dose reductions for adverse reactions associated with LAZCLUZE are presented in Table 1. Table 1 - Recommended LAZCLUZE Dose Reductions for Adverse Reactions Dose Reduction Recommended Dosage Initial dose 240 mg once daily 1st dose reduction 160 mg once daily 2nd dose reduction 80 mg once daily 3rd dose reduction Discontinue LAZCLUZE Dose modifications for specific adverse reactions are presented in Table 2.
Table 2 - Recommended LAZCLUZE and amivantamab Dose Modifications for Adverse Reactions Adverse Reaction Severity† Dose Modification Interstitial Lung Disease (ILD)/ pneumonitis (see 7 WARNINGS AND PRECAUTIONS, Respiratory and 8 ADVERSE REACTIONS) Any Grade • Withhold LAZCLUZE and amivantamab if ILD/pneumonitis is suspected.
• Permanently discontinue LAZCLUZE and amivantamab if ILD/pneumonitis is confirmed. Venous Thromboembolic (VTE) Events (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS) Grade 2 or 3 • Withhold LAZCLUZE and amivantamab. • Administer anticoagulant treatment as clinically indicated.
• Once anticoagulant treatment has been initiated LAZCLUZE and amivantamab can be resumed at the same dose level, at the discretion of the healthcare professional. Grade 4 or recurrent Grade 2 or 3 despite • Withhold LAZCLUZE and permanently discontinue amivantamab.
0 LAZCLUZE (lazertinib tablets) Page 6 of 32 Adverse Reaction Severity† Dose Modification therapeutic level of anticoagulation • 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 professional.
Skin and Nail Reactions (including dermatitis acneiform, pruritus, dry skin) (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS) Grade 2 • If there is no improvement after 2 weeks of supportive care, reduce amivantamab dose and continue LAZCLUZE.
, Respiratory and
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• Reassess every 2 weeks, if no improvement, reduce LAZCLUZE dose until ≤ Grade 1 (Table 1). Grade 3 • Withhold LAZCLUZE and amivantamab until the adverse reaction resolves 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) • Permanently discontinue amivantamab.
• Withhold LAZCLUZE until the adverse reaction resolves to ≤ Grade 2 or baseline. • Resume LAZCLUZE at the same dose or consider dose reduction. Symptomatic congestive heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular and 8 ADVERSE REACTIONS) Any Grade • Permanently discontinue LAZCLUZE Other Adverse Reactions (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS) Grade 3-4 • Withhold LAZCLUZE and amivantamab until the adverse reaction resolves to ≤ Grade 1 or baseline.
• Resume one or both drugs at a reduced dose or LAZCLUZE alone. 0 LAZCLUZE (lazertinib tablets) Page 7 of 32 Adverse Reaction Severity† Dose Modification and amivantamab if recovery does not occur within 4 weeks. • Permanently discontinue both LAZCLUZE and amivantamab for recurrent Grade 4 reactions.
0 Refer to the amivantamab product monograph for information about dose modifications for infusion-related reactions (IRR). 4. Administration This medicinal product is for oral use. Swallow tablets whole with or without food. Do not crush, split, or chew the tablet.
If vomiting occurs any time after taking LAZCLUZE, instruct the patient to take the next dose at its next regularly scheduled time. 5. Missed Dose 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 not administer the missed dose and administer the next dose per the usual dosing schedule.
5. Overdose The maximum tolerated dose of LAZCLUZE has not been determined. In clinical trials, daily doses of up to 320 mg once daily have been administered. There is no known specific antidote for LAZCLUZE overdose. In the event of an overdose, stop LAZCLUZE and undertake general supportive measures.
Patients should be closely monitored for signs or symptoms of adverse reactions. For management of a suspected drug overdose, contact your regional poison control centre. 6. Dosage Forms, Strengths, Composition, and Packaging Table 3 - Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet, 80 mg and 240 mg lazertinib (as lazertinib […]