LAZCLUZE
Generic Name/API: lazertinib
Manufacturer: Janssen Biotech, Inc.
Dosage Forms & Strength & Pack Size:
Tablets: 80 mg and 240 mg.
Storage:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
LAZCLUZE
is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult 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 FDA-approved test.
• Venous Thromboembolic Events (VTE): Prophylactic anticoagulation is recommended for the first four months of treatment. Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold LAZCLUZE and amivantamab based on severity. Once anticoagulant treatment has been initiated, resume LAZCLUZE and amivantamab at the same dose at the discretion of the healthcare provider. Permanently discontinue amivantamab and continue LAZCLUZE for recurrent VTE despite therapeutic anticoagulation. (2.4, 5.1)
• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening symptoms indicative of ILD/pneumonitis. Withhold LAZCLUZE and amivantamab in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. (2.4, 5.2)
• Dermatologic Adverse Reactions: May cause severe rash including acneiform dermatitis. Administer alcohol-free emollient cream and encourage patients to limit sun exposure during and for 2 months after treatment to reduce the risk of dermatologic reactions. Withhold, reduce the dose or permanently discontinue LAZCLUZE and amivantamab based on severity. (2.4, 5.3)
• Ocular Adverse Reactions: Promptly refer patients with new or worsening signs and symptoms of ocular adverse reactions, including keratitis, to an ophthalmologist for evaluation. Withhold, reduce the dose, or permanently discontinue amivantamab and continue LAZCLUZE based on severity. (5.4)
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.5, 8.1, 8.3)
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