Product image of Lazcluze (Lazertinib Mesilate Monohydrate) supplied by GNH India

Lazcluze

Active Ingredient:
Lazertinib Mesilate Monohydrate
Origin:
EU

Lazcluze (Lazertinib Mesilate Monohydrate)

Lazertinib, the active ingredient in Lazcluze, is a tyrosine kinase inhibitor presented as a unknown/unknown for oral use. It treats non‑small cell lung cancer that carries epidermal growth factor receptor (EGFR) mutations in adult patients.

GNH India supplies Lazcluze as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Janssen-Cilag International Nv

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Indications & Clinical Uses

  • Lazcluze is a targeted therapy that acts on EGFR‑mutated non‑small cell lung cancer.
  • Non‑small cell lung cancer with EGFR mutations: improves progression‑free survival and tumor response in patients whose tumours harbor activating EGFR alterations.

How It Works

  • Lazertinib mesilate monohydrate selectively inhibits the tyrosine kinase activity of the epidermal growth factor receptor (EGFR), including common activating mutations such as exon 19 deletions and L858R. By blocking ATP binding to the mutant EGFR kinase domain, it prevents downstream signaling pathways that drive cell proliferation and survival, leading to tumor growth inhibition.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Diarrhea: mild to moderate gastrointestinal upset.
  • Skin rash: papulopustular eruption, often on the face or trunk.
  • Nausea: occasional feeling of queasiness.
  • Decreased appetite: reduced food intake.
  • Fatigue: general tiredness.
  • Elevated liver enzymes: transient increase in ALT/AST.

Serious or Rare Side Effects

  • Interstitial lung disease: new or worsening respiratory symptoms.
  • Severe hepatic injury: marked elevation of liver enzymes or jaundice.
  • QT interval prolongation: potential cardiac arrhythmia risk.
  • Stevens‑Johnson syndrome: severe skin and mucosal reactions.
  • Grade 3/4 neutropenia: significant reduction in white blood cells.
  • Hepatotoxicity: liver failure requiring medical intervention.

Precautions & Warnings

  • Patients should be monitored for specific safety concerns before and during treatment.
  • Liver function monitoring: assess ALT, AST, and bilirubin regularly.
  • Cardiac assessment: obtain baseline ECG and monitor QT interval.
  • Pulmonary evaluation: watch for signs of interstitial lung disease.
  • Avoid use in severe hepatic impairment: contraindicated in patients with Child‑Pugh C.
  • Drug interaction awareness: review concomitant medications that affect CYP3A4.
  • Store at below 25°C: keep in original container, protect from moisture and light.

Avoid Interactions

Lazcluze may interact with other medicines that influence its metabolism or cardiac safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase plasma concentrations.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
  • QT‑prolonging agents (e.g., certain antiarrhythmics): additive risk of arrhythmia.

Moderate Interactions (Monitor Closely):\n- Antacids containing aluminum or magnesium: may affect absorption, separate dosing by at least 2 hours.

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise drug levels.
  • Warfarin: monitor INR as EGFR inhibitors can alter coagulation parameters.

Frequently Asked Questions

Lazcluze contains lazertinib, an EGFR‑targeted tyrosine kinase inhibitor indicated for the treatment of adult patients with non‑small cell lung cancer that harbors activating EGFR mutations. It is used when the tumour’s genetic profile matches the drug’s mechanism of action.

Lazertinib binds to the ATP‑binding pocket of mutant EGFR kinase domains, blocking phosphorylation of downstream signaling proteins. This inhibition stops the proliferative and survival signals that drive cancer cell growth, leading to tumor regression in EGFR‑mutated lung cancers.

The prescribed dose of Lazcluze is determined by the treating oncologist based on the patient’s clinical condition, renal and hepatic function, and any concomitant therapies. The prescriber sets the exact regimen and schedule.

Safety data for lazertinib in pregnancy and lactation are limited. It is generally advised to avoid use during pregnancy unless the potential benefit justifies the risk, and breastfeeding is not recommended while receiving the medication.

To request Lazcluze, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.

Lazcluze (lazertinib) is a third‑generation EGFR inhibitor designed to target both sensitizing and resistant EGFR mutations, including T790M. Compared with first‑generation agents (e.g., erlotinib) and second‑generation agents (e.g., afatinib), lazertinib often shows improved activity against resistant mutations and a distinct safety profile.

Lazcluze should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and direct light. Keep the product out of reach of children and avoid storing in humid environments such as bathrooms.

Lazcluze is taken orally, usually as a whole tablet swallowed with water. It is typically administered once daily, preferably at the same time each day, and may be taken with or without food as directed by the prescriber.

Serious risks include interstitial lung disease, severe hepatic injury, QT interval prolongation, and rare but severe skin reactions such as Stevens‑Johnson syndrome. Patients should be monitored regularly for respiratory symptoms, liver function abnormalities, and cardiac changes.

Lazcluze is contraindicated in patients with known hypersensitivity to lazertinib or any excipients, and in those with severe hepatic impairment (Child‑Pugh C). Caution is also advised for patients with a history of cardiac arrhythmias or uncontrolled QT prolongation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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