Lazertinib (Lazcluze™)

How to Take Lazertinib

Lazertinib is taken once a day, by mouth, in tablet form. Swallow the tablets whole. Do not crush, split, or chew the tablet. You can take lazertinib with or without food. When given on the same day as amivantamab, take lazertinib any time before you receive the infusion. During treatment you will take an anticoagulant (blood thinning medication) to prevent blood clots in your veins, called venous thromboembolism (VTE). 

If you miss your dose and it is within 12 hours of when you were supposed to take it, take the missed dose as soon as possible. If you miss your dose and it has been more than 12 hours, skip the missed dose and take your next dose as scheduled. If you vomit after taking this medication, do not take an extra dose. Instead, take your next dose as scheduled. Consult with your pharmacist or provider if you are having trouble swallowing the medication.

You may be told to use an alcohol-free cream on your skin when you start treatment with lazertinib in combination with amivantamab. Limit sun exposure during treatment and for at least 2 months after your last dose.  You should also wear protective clothing and use broad-spectrum UVA/UVB sunscreen to lower the risk of serious skin problems.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed. Certain medications can interfere with lazertinib, so make sure your provider is aware of all the medications, vitamins and supplements you are taking, including but not limited to: rifampin, efavirenz, itraconazole, midazolam, and rosuvastatin.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw it in the trash.

Where do I get this medication?

Lazertinib is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for distribution of this medication and shipment directly to your home.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.

Possible Side Effects of Lazertinib

The following side effects are possible when lazertinib and amivantamab are given together. There are a number of things you can do to manage these side effects. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Rash and Skin Reactions

Some patients may develop a rash, dry skin, or itchy bumps. Rashes can be serious, including acneiform dermatitis. Use an alcohol-free moisturizer on your skin and lips. Avoid moisturizers with perfumes or scents. Your oncology care team can recommend a topical medication if itching is bothersome. If your skin does crack or bleed, be sure to keep the area clean to avoid infection. Your skin may be more sensitive to the sun, which can result in severe sunburn or rash. Sun sensitivity can last even after chemotherapy is completed, up to at least 2 months after treatment. Avoid the sun between 10 to 2pm when it is strongest. Wear sunscreen (at least SPF 30 with UVA/UVB protection) every day and reapply when in the sun for long periods of time. Wear sunglasses with UVA/UVB protection, a hat, and long sleeves/pants to protect your skin and, try to find shade whenever possible.

Tell your oncology care team about any rash that develops, as this can be a reaction. They can give you more tips on caring for your skin.

Nail Toxicity

There is a risk of the skin around your nails becoming infected. Your fingernails/toenails and the skin around them may become sore, red, and brittle, and the nails may fall off. Keep your fingernails and toenails clean and dry. You may use nail polish but do not wear fake nails (gels, acrylics, overlay). If any nails fall off, clean the nail bed well with soap and water and cover with a band-aid.

Muscle or Joint Pain/Aches

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Mouth Ulcers (Mucositis)

Certain cancer treatments can cause sores or soreness in your mouth and/or throat. Notify your oncology care team if your mouth, tongue, inside of your cheek or throat becomes white, ulcerated or painful. Performing regular mouth care can help prevent or manage mouth sores. If mouth sores become painful, your doctor or nurse can recommend a pain reliever.

• Brush with a soft-bristle toothbrush or cotton swab twice a day.
• Avoid mouthwashes that contain alcohol. A baking soda and/or salt with warm water mouth rinse (2 level teaspoons of baking soda or 1 level teaspoon of salt in an eight ounce glass of warm water) is recommended 4 times daily.
• If your mouth becomes dry, eat moist foods, drink plenty of fluids (6-8 glasses), and suck on sugarless hard candy.
• Avoid smoking and chewing tobacco, drinking alcoholic beverages and citrus juices.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding use of these agents and all over the counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth. 

Peripheral Edema

Peripheral edema is swelling of the extremities caused by retention of fluid. It can cause swelling of the hands, arms, legs, ankles and feet. The swelling can become uncomfortable. Notify your oncology care team if you are experiencing any new or worsening swelling.

Diarrhea

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Electrolyte Abnormalities and Changes to Liver Function Tests

This medication can affect the normal levels of electrolytes (calcium, sodium, potassium, magnesium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

This medication can also cause changes to certain levels of liver enzymes in your blood, which will be monitored with blood tests called liver function tests (LFTs). Tell your provider if you notice yellowing of your skin or whites of your eyes, pain in your abdomen (belly), or darker urine that normal. 

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Decrease in Appetite 

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your oncology care team about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products, and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce, or dressings. Use seasonings like basil, oregano, or rosemary to add flavor. Bacon, ham, and onion can add flavor to vegetables.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy /fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Constipation

There are several things you can do to prevent or relieve constipation. Include fiber in your diet (fruits and vegetables), drink 8-10 glasses of non-alcoholic fluids a day, and keep active. A stool softener once or twice a day may prevent constipation. If you do not have a bowel movement for 2-3 days, you should contact your healthcare team for suggestions to relieve the constipation.

Paresthesia

Paresthesia can happen in any part of your body and can feel like pins and needles, numbness, or burning just underneath your skin. Let your oncology care team know if you have numbness or tingling in any part of your body, as they may need to adjust the doses of your medication.

Infection and Low White Blood Cell Count (Leukopenia or Neutropenia)

This medication can cause life-threatening infections, with or without a decrease in white blood cell counts. 

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.

Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (like those who have a cold, fever, or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with, has any vaccinations.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, (node 2101) you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Less common but important side effects can include:

• Hemorrhage (Bleeding):  Patients may experience minor bleeding, such as a nosebleed. Serious bleeding has also occurred in patients treated with this medication, including coughing up blood, bleeding into the stomach, blood in stool, vomiting blood, bleeding in the brain (stroke), nosebleeds, and blood in the urine. People who have had serious bleeding should not take this medication. These events are uncommon, though if they occur, lazertinib should be discontinued. While a nosebleed may not seem like much of a concern, you should notify your healthcare team right away if you develop bleeding of any sort.
• Blood Clots (Venous Thromboembolism/VTE):  This medication can cause blood clots to form in your veins. VTE includes deep vein thrombosis (DVT) and pulmonary embolism (PE). Signs and symptoms can include swollen and painful legs or arms, new onset of shortness of breath or pain when you take a deep breath, chest pain under your rib cage, fast heart rate, a new cough with or without blood, and feeling anxious. If you have any of these symptoms, call your 911 or go to the nearest emergency room. While you are on therapy, you may be on an anticoagulant (blood thinning medication) to prevent blood clots.
• Interstitial Lung Disease/Pneumonitis:  Patients can develop interstitial lung disease (scarring of the lung tissue) or pneumonitis (inflammation of the lungs) while taking this medication, especially during the first week.  Notify your healthcare provider right away if you develop any new or worsening symptoms, including trouble breathing or shortness of breath, chest pain, cough, or fever.
• Ocular (Eye) Toxicity:  This medication, when used with amivantamab, can cause problems with your eyes, including keratitis. Tell your care team about any new or worsening vision or eye symptoms, such as blurry vision, redness, eye pain, excess tears or discharge from your eye, sensitivity to light, or a feeling that something is in your eye. You may need to see an ophthalmologist for treatment.

Sexual and Reproductive Concerns

This medication may affect your reproductive system, resulting in the menstrual cycle or sperm production becoming irregular or stopping permanently.

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 3 weeks after your last dose, even if your menstrual cycle stops or you believe you are not producing sperm. You should not breastfeed while receiving this medication and for at least 3 weeks after your last dose.