LuciLazer 80 MG (Lazertinib)

Description

Lazertinib Tablets 80mg

Each tablet contains: Lazertinib ………………………………80mg

INDICATIONS AND USAGE

LuciLazer 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.

DOSAGE AND ADMINISTRATION

• The recommended dosage of LuciLazer is 240 mg orally once daily with or without food, given in combination with amivantamab. • Continue treatment until disease progression or unacceptable toxicity. • Administer LuciLazer any time prior to amivantamab when given on the same day. • Refer to the amivantamab prescribing information for recommended amivantamab dosing information. • Administer anticoagulant prophylaxis to prevent venous thromboembolic events (VTE) for the first four months of treatment.

DOSAGE FORMS AND STRENGTHS

Tablets: 80 mgx60 tablets

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

• 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 LuciLazer and amivantamab based on severity. Once ant icoagulant treatment has been initiated, resume LuciLazer and amivantamab at the same dose at the discretion of the healthcare provider. Permanently discontinue amivantamab and continue LuciLazer for recurrent VTE despite therapeutic anticoagulation. • Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening symptoms indicative of ILD/pneumonitis. Withhold LuciLazer and amivantamab in patients with suspecter ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. • 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 LuciLazer and amivantamab based on severity. • 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 Lucilazer based on severity. • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

LuciLazer in Combination with Amivantamab • The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion- related reaction (amivantamab), musculoskeletal pain, edema, stomatitis, VTE,

paresthesia, fatigue, diarrhea, constipation, COVID -19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity. • The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium.

DRUG INTERACTIONS

Strong and moderate CYP3A4 inducers:Avoid concomitant us

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

STORAGE

Store at 20℃ to 25℃, excursions permitted between 15℃ and 30℃ [see USP Controlled Room Temperature]. Protect from moisture.

MANUFACTURED AND MARKETED BY

Lucius Pharmaceuticals (LAO )CO., LTD Thomang Village, Xaythany district, Vientiane Capital, Laos.