Lucius Lazertinib Patient Information Leaflet

Generic Name: Lazertinib (la-ZER-ti-nib)
Therapeutic Class: Third-generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI)
Manufacturer: Lucius Pharmaceuticals
Dosage: This leaflet primarily covers the 240 mg tablet strength.

1. What is Lucius Lazertinib and what is it used for?

Lucius Lazertinib is a prescription medicine used to treat a specific type of advanced (metastatic) non-small cell lung cancer (NSCLC). It is designed for adult patients whose cancer has an abnormal epidermal growth factor receptor (EGFR) gene and who have a specific mutation called T790M.

• It is used when the cancer has gotten worse after treatment with another EGFR tyrosine kinase inhibitor medicine.

• It works by blocking the signals from the mutated EGFR protein that tell the cancer cells to grow and multiply.

2. Before you take Lucius Lazertinib

Do NOT take this medicine if you:

• Are allergic to lazertinib or any of the other ingredients in this medicine.

Warnings and Precautions:
Talk to your doctor before taking Lucius Lazertinib if you have or have had:

• Lung Problems (Interstitial Lung Disease [ILD]/Pneumonitis): This drug can cause serious inflammation of the lungs that can be fatal. Seek immediate medical attention if you develop new or worsening respiratory symptoms such as shortness of breath, cough, or fever.

• Skin Reactions: Skin reactions, including rash, acne, dry skin, itching, and redness, are very common. In rare cases, more severe reactions can occur.

• Heart Problems (QTc Prolongation): Lazertinib can affect the electrical activity of your heart, which could lead to irregular heart rhythms. Your doctor will perform tests (ECG) to monitor your heart, especially if you have pre-existing heart conditions or are taking other drugs that affect heart rhythm.

• Liver Problems: This medication can cause liver injury. Your doctor will perform regular blood tests to monitor your liver function.

• Eye Problems: Inform your doctor if you experience any eye problems, including redness, pain, dryness, or vision changes (like blurred vision).

Pregnancy and Breastfeeding:

• Pregnancy: This drug may harm an unborn baby. Use highly effective non-hormonal contraception during treatment and for at least 3 months after your last dose. Note: Hormonal birth control (e.g., pills) may not be effective when taken with lazertinib. Discuss the best contraceptive methods with your doctor.

• Breastfeeding: Do not breastfeed during treatment and for at least 2 weeks after your last dose, as it is unknown if the drug passes into breast milk.

Other Medicines and Supplements:
Tell your doctor about ALL the medicines you take. This is extremely important for drugs that affect liver enzymes, such as:

• Strong CYP3A Inducers: Rifampin, carbamazepine, phenytoin, St. John's Wort, etc. These must be avoided, as they can significantly decrease the effectiveness of lazertinib.

3. How to take Lucius Lazertinib

• Dosage: The typical dose is 240 mg (two 120 mg tablets or a single 240 mg tablet, depending on formulation) taken once daily.

• Administration:

  • Take the tablet(s) by mouth with a full glass of water.

  • You can take it with or without food.

  • Swallow the tablets whole; do not crush, chew, or split them.

• Timing: Try to take your dose at approximately the same time every day.

• Missed Dose:

  • If you miss a dose, take it as soon as you remember on the same day.

  • If it is the next day, skip the missed dose and take your next dose at the regular time.

  • Do not take a double dose to make up for a missed one.

• Vomiting: If you vomit after taking a dose, do not take an extra dose. Continue with your next scheduled dose.

4. Possible Side Effects

Very Common Side Effects (may affect more than 1 in 10 people):

• Skin reactions (rash, acne, itching, dry skin)

• Diarrhea

• Nausea and vomiting

• Decreased appetite

• Headache

• Fatigue

• Nail problems (inflammation, pain, discoloration)

• Mouth sores

• Itching (pruritus)

• Cough

• Constipation

• Muscle and joint pain

• Elevated liver enzymes (shown in blood tests)

Serious Side Effects (Contact your doctor immediately if you experience any of these):

• Signs of lung problems: New or worsening cough, shortness of breath, difficulty breathing, fever.

• Signs of heart problems: Palpitations (feeling your heartbeat), fast or irregular heartbeat, dizziness, fainting.

• Signs of severe liver problems: Yellowing of the skin or eyes (jaundice), dark urine, severe nausea or vomiting, pain on the right side of the stomach.

• Severe skin reactions: Painful red rash, skin blistering or peeling, mouth sores.

5. How to Store Lucius Lazertinib

• Store at room temperature in the original container to protect from moisture and light.

• Keep out of reach of children and pets.

• Do not use this medicine after the expiration date printed on the pack.

6. Contents of the Pack and Other Information

• Active Ingredient: Lazertinib (e.g., 240 mg per tablet or 120 mg per tablet).

• Inactive Ingredients: Includes microcrystalline cellulose, mannitol, and other tablet-forming agents.

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