Lazertinib

Lazertinib is used together with amivantamab to treat adults with a specific type of non-small cell lung cancer that has spread to other areas of the body (metastatic) or cannot be removed by surgery.

Your doctor will confirm that you have the right tumor type to be treated with lazertinib.

Lazertinib may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your doctor will perform tests to make sure lazertinib is the right treatment for you.

Lazertinib is usually taken once per day with or without food on the same day of or before receiving your infusion with amivantamab.

Swallow the tablet whole and do not crush, chew, or break it.

You may be given other medications to help prevent serious side effects or allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.

If you vomit shortly after taking lazertinib, do not take another dose. Take your next dose as scheduled.

You will need frequent medical tests, and your dose or medication schedule may be changed based on the results.

Do not change your dose or stop using this medicine without your doctor's advice. Do not start or stop any medicine without asking your doctor.

Store in the original package at room temperature away from moisture and heat.

Lazertinib can lead to serious or life-threatening side effects. Contact your doctor immediately if you experience chest pain, sudden cough, shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg, sudden numbness or weakness (especially on one side of your body), severe headache, slurred speech, or issues with vision or balance.

Tell your doctor if you have or have ever had:

• lung or breathing problems other than lung cancer.

Lazertinib can harm an unborn baby if either the mother or the father is using lazertinib.

• If you are a woman, you may need a pregnancy test to confirm that you are not pregnant. Use birth control while taking this medicine and for at least 3 weeks after your last dose.
• If you are a man, use birth control if your sex partner can become pregnant. Continue using birth control for at least 3 weeks after your last dose.
• Inform your doctor immediately if a pregnancy occurs.

Do not breastfeed while taking this medicine, and for at least 3 weeks after your last dose.

Lazertinib may affect fertility in both men and women. It could be harder to achieve pregnancy while either parent is taking this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Lazertinib may cause serious side effects. Call your doctor right away if you have:

• severe skin reactions--small, raised, acne-like bumps, skin rash, itching, or dryness;
• eye problems--eye pain or redness, itching, dry or watery eyes, increased sensitivity to light, or changes in your vision such as blurred vision;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood; or
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg.

Your cancer treatments may be delayed, reduced, or permanently stopped if you have certain side effects.

Common side effects of lazertinib may include:

• tingly feeling or unusual skin sensations;
• infected skin around the nail;
• diarrhea or constipation;
• bleeding, mouth sores;
• nausea, loss of appetite;
• muscle or joint pain;
• itchy skin rash;
• tiredness;
• swelling in your face or any other part of your body; or
• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Non-Small Cell Lung Cancer:

240 mg orally once a day administered in combination with amivantamabDuration of therapy: Until disease progression or unacceptable toxicityComments:-Refer to the amivantamab prescribing information for recommended dosing information for that drug.Use: For the first-line treatment of 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 a US FDA-approved test

Take the medicine as soon as you can, but if your next dose is due within 12 hours, skip the missed dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Lazertinib could make you more likely to get sunburned. Avoid sunlight or tanning beds during treatment and for at least 2 months after your last dose. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors, and use alcohol-free moisturizing cream.

If you have vision problems, avoid wearing contact lenses until an eye doctor (ophthalmologist) can check your symptoms.

Sometimes it is not safe to use certain medicines together. Some drugs can change how much of other drugs is in your blood, which may increase side effects or make the medicines work less effectively.

Other drugs may affect lazertinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you take.