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Lazcluze is a brand name for Lazertinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Lazcluze should be initiated by a physician experienced in the use of anticancer medicinal products. Before initiation of Lazcluze, EGFR mutation-positive status in tumour tissue or plasma specimens must be established using a validated test method.
If no mutation is detected in a plasma specimen, tumour tissue should be tested if available in sufficient amount and quality due to the potential for false negative results using a plasma test. 3 Posology The recommended dose of Lazcluze is 240 mg once daily in combination with amivantamab.
It is recommended to administer Lazcluze any time prior to amivantamab when given on the same day. 2 of the amivantamab Summary of Product Characteristics for recommended amivantamab dosing information. Venous thromboembolic (VTE) events with concomitant use with amivantamab At the initiation of treatment, prophylactic anticoagulants should be administered to prevent venous thromboembolic (VTE) events in patients receiving Lazcluze in combination with amivantamab.
Consistent with clinical guidelines, patients should receive prophylactic dosing of either a direct acting oral anticoagulant (DOAC) or a low molecular weight heparin (LMWH). Use of Vitamin K antagonists is not recommended. Skin and nail reactions Prophylactic therapy with oral and topical antibiotics is recommended to reduce the risk and severity of skin and nail reactions in patients receiving Lazcluze in combination with amivantamab.
Non- comedogenic skin moisturiser (ceramide-based or other formulations that provide long-lasting skin hydration and exclude drying agents are preferred) on the face and whole body (except scalp) and chlorhexidine solution to wash hands and feet is also recommended.
Patients should be instructed to limit sun exposure during and for 2 months after Lazcluze combination therapy. For further information about prophylaxis for skin and nail reactions, see section
Summary of the safety profile The most frequent adverse reactions in all grades were rash (89%), nail toxicity (71%), infusion-related reaction (amivantamab) (63%), hypoalbuminaemia (amivantamab) (48%), hepatotoxicity (47%), oedema (amivantamab) (47%), stomatitis (43%), venous thromboembolism (37%), paraesthesia (34%), fatigue (32%), constipation (29%), diarrhoea (29%), dry skin (26%), decreased appetite (24%), pruritus (24%), hypocalcaemia (21%), other eye disorders (21%) and nausea (21%).
2%). 7%). Tabulated list of adverse reactions Table 3 summarises the adverse reactions that occurred in patients receiving lazertinib in combination with amivantamab. The data reflects exposure to lazertinib in 421 patients who received lazertinib in combination with amivantamab in MARIPOSA.
4 months). Adverse reactions observed during clinical studies are listed below by frequency category. Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 8 Pyrexia 12 0 Injury, poisoning and procedural complications Infusion-related reactionb Very common 63 6 a grouped terms b applicable only to amivantamab.
3%), were reported in 37% of patients receiving lazertinib in combination with amivantamab. 5% of patients receiving lazertinib in combination with amivantamab. 4. 11 In patients receiving lazertinib in combination with amivantamab, the median time to first onset of a VTE event was 84 days.
9% of patients. , pneumonitis) have been reported with the use of lazertinib in combination with amivantamab as well as with other EGFR inhibitors. 2% fatal cases. 4). Skin and nail reactions Rash (including dermatitis acneiform), pruritus and dry skin has occurred.
4. Duration of treatment Treatment should continue until disease progression or unacceptable toxicity. Missed dose If a planned 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, the missed dose should not be administered and the next dose should be administered per the usual dosing schedule.
Dose modifications The recommended dose reductions for adverse reactions are presented in Table 1.
Table 1:
Recommended Lazcluze dose reductions for adverse reactions Dose reduction Recommended dose 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.
2 of the amivantamab Summary of Product Characteristics for information about dose modifications for amivantamab. 4 Table 2: Recommended Lazcluze and amivantamab dose modifications for adverse reactions* Adverse reaction Severity Dose modification Interstitial lung disease (ILD)/pneumonitis Any grade Withhold Lazcluze and amivantamab if ILD/pneumonitis is suspected.
Permanently discontinue Lazcluze and amivantamab if ILD/pneumonitis is confirmed. , respiratory failure or cardiac dysfunction) Withhold Lazcluze and amivantamab until the patient is clinically stable. Thereafter, both medicinal products can be resumed at the same dose.
Recurrent VTE event despite therapeutic level anticoagulation Permanently discontinue amivantamab. Treatment can continue with Lazcluze at the same dose. 4) Grade 1 Supportive care should be initiated as clinically indicated. Reassess after 2 weeks.
Grade 2 Supportive care should be initiated as clinically indicated. If there is no improvement after 2 weeks, reduce amivantamab dose and continue Lazcluze. Reassess every 2 weeks, if no improvement, reduce Lazcluze dose until ≤ Grade 1 (Table 1).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rash occurred in 89% of patients treated with lazertinib in combination with amivantamab. Most cases were Grade 1 or 2, with Grade 3 events occurring in 27% of patients. Rash leading to any treatment discontinuation occurred in 6% of patients.
Rash usually developed within the first 4 weeks of therapy, with a median time to onset of 14 days. Nail toxicity occurred in patients treated with lazertinib in combination with amivantamab. 4). 4). A reduction in the incidence of ≥ Grade 2 dermatologic adverse events during the first 12 weeks of treatment was demonstrated, compared with the standard dermatologic […]
Grade 3 Supportive care should be initiated as clinically indicated. Withhold Lazcluze and amivantamab. Upon recovery to ≤ Grade 2, resume both medicinal products at the same dose or consider dose reduction, preferentially reducing the dose of amivantamab first.
If there is no improvement within 2 weeks, permanently discontinue both Lazcluze and amivantamab. , Toxic epidermal necrolysis) Permanently discontinue amivantamab and hold Lazcluze. Withhold Lazcluze until ≤ Grade 2 or baseline.
Upon recovery to ≤ Grade 2, resume Lazcluze at the same dose. Hepatotoxicity Grade 3-4 Withhold Lazcluze and amivantamab. Upon recovery to ≤ Grade 1, resume both medicinal products at the same dose or consider dose reduction, preferentially reducing the dose of amivantamab first.
5 Paraesthesia Grade 3-4 Supportive care should be initiated. Withhold Lazcluze until ≤ Grade 1 or baseline. Resume Lazcluze at the same dose or consider dose reduction. Consider permanently discontinuing Lazcluze if recovery does not occur within 4 weeks.
Diarrhoea Grade 3 Supportive care should be initiated. Withhold Lazcluze and amivantamab. Upon recovery to ≤ Grade 1, resume both medicinal products at the same dose or consider dose reduction, preferentially reducing the dose of amivantamab first.
Grade 4 Supportive care should be initiated. Withhold Lazcluze and amivantamab. Upon recovery to ≤ Grade 1, reduce the dose, preferentially reducing the dose of amivantamab first. Stomatitis Grade 3-4 Withhold Lazcluze and amivantamab.
Upon recovery to ≤ Grade 2, resume both medicinal products at the same dose or consider dose reduction, preferentially reducing the dose of amivantamab first. Other adverse reactions Grade 3-4 Withhold Lazcluze and amivantamab until the adverse reaction resolves to ≤ Grade 1 or baseline.
Resume one or both medicinal products, preferentially resuming Lazcluze first at a reduced dose, unless the adverse reaction is strongly suspected to be related to Lazcluze. Consider permanently discontinuing both Lazcluze and amivantamab if recovery does not occur within 4 weeks.
2 of the amivantamab Summary of Product Characteristics for recommended amivantamab dosing information. 2). Renal impairment Based on population pharmacokinetics (PK) analysis, no dose adjustment is required for patients with mild, moderate or severe renal impairment.
Data in patients with severe renal impairment are limited. 6 The PK of lazertinib in patients with end stage renal disease is unknown. 2). Hepatic impairment 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. 2). Paediatric population There is no relevant use of lazertinib in the paediatric population for the treatment of non-small cell lung cancer. Method of administration Lazcluze is for oral use.
The tablets should be swallowed whole with or without food. Tablets should not be crushed, split, or chewed. If vomiting occurs any time after taking Lazcluze, the next dose should be taken the next day. 1. 8). Patients with a medical history […]