Lazertinib

Lazertinib is used in combination with amivantamab-vmjw (Rybrevant) as an initial treatment for a certain type of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body Lazertinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Lazertinib comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take lazertinib at around the same time every day. On the days that your receive amivantamab-vmjw injection, take lazertinib at any time before you receive the injection. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lazertinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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

If you vomit after taking lazertinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may need to temporarily or permanently stop your treatment or decrease your dose if you experience certain side effects. Be sure to talk to your doctor about how you are feeling during your treatment with lazertinib.

The length of your treatment depends on how well you respond to the medication and the side effects you experience. Continue to take lazertinib even if you feel well. Do not stop taking lazertinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking lazertinib,

• tell your doctor and pharmacist if you are allergic to lazertinib, any other medications, or any of the ingredients in lazertinib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with lazertinib: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking lazertinib. Do not start this medication while taking lazertinib without discussing with your healthcare provider
• tell your doctor if you have or have ever had lung disease or breathing problems; a blood clot in your legs, arms, or lungs; dry skin or other skin problems; or vision or eye problems.
• you should know that lazertinib may decrease fertility in men and women. However, you should not assume that you or your partner cannot become pregnant. Tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you begin treatment with lazertinib. If you or your partner can become pregnant, you should use birth control during your treatment with lazertinib and for 3 weeks after your final dose. If you or your partner become pregnant while you are taking lazertinib, call your doctor immediately. Lazertinib may harm the fetus.
• tell your doctor if you are breastfeeding. Your doctor will tell you not to breastfeed during your treatment with lazertinib and for 3 weeks after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lazertinib.
• you should know that lazertinib may cause serious or life-threatening blood clots in the lungs or legs. Tell your doctor if you smoke or if you have ever smoked. Your doctor will probably tell you to take another medication to prevent blood clots for the first 4 months of treatment. If you experience any of the following symptoms during your treatment, call your doctor immediately or get emergency medical treatment: chest pain; shortness of breath; swelling of a leg or arm; leg pain; redness, discoloration, or warmth in the legs or arms.
• you should know that lazertinib may cause skin reactions, including some that may be severe. You should plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen while you are taking lazertinib and for 2 months after your final dose. Your doctor may tell you to use an alcohol-free moisturizer to protect your skin and help prevent skin reactions. Your doctor may also tell you to take a certain medication to prevent or treat skin reactions or may send you to see dermatologist (skin doctor). If you experience any of the following symptoms, call your doctor immediately: rash, itching, dry or cracking skin, or blistering, peeling, or shedding skin.
• your should know that lazertinib can cause eye problems, including changes to the cornea (clear tissue that covers the front of the eye). If you experience any of the following symptoms, call your doctor immediately: blurred vision, loss of vision, eye pain or redness, or other visual changes. Your doctor may send to you to an ophthalmologist (eye doctor). If you have any eye problem and wear contact lenses, you should stop wearing them and not wear them again until you see an eye doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if more than 12 hours passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Lazertinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• muscle, joint pain
• diarrhea
• constipation
• nausea
• vomiting
• mouth sores
• stomach pain
• decreased appetite
• hemorrhoids
• tiredness
• dizziness
• headache
• numbness or tingling of the skin
• swelling or the hands, ankles, feet, face, or body
• redness or swelling around the fingernails or toenails
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately :

• new or worsening cough, difficulty breathing, wheezing, chest tightness, fever, or shortness of breath
• unusual bruising or bleeding

Lazertinib cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to lazertinib. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with lazertinib.

Do not let anyone else take your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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