Description
Lazertinib is used in combination with amivantamab as a first-line treatment for non-small cell lung cancer (NSCLC) that is metastatic (cancer that has spread) or cannot be removed by surgery in patients who have an abnormal epidermal growth factor receptor (EGFR) gene (exon 19 deletions or exon 21 L858R substitution mutations). Your doctor will perform a test before you take this medicine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of lazertinib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lazertinib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abemaciclib
- Acalabrutinib
- Alfentanil
- Apalutamide
- Astemizole
- Axitinib
- Bosentan
- Bosutinib
- Brigatinib
- Carbamazepine
- Cenobamate
- Ceritinib
- Cisapride
- Clindamycin
- Cobimetinib
- Colchicine
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabrafenib
- Dasatinib
- Dihydroergotamine
- Dipyrone
- Docetaxel
- Dofetilide
- Dronedarone
- Efavirenz
- Elagolix
- Entrectinib
- Enzalutamide
- Ergotamine
- Etravirine
- Everolimus
- Fentanyl
- Flibanserin
- Fosphenytoin
- Ivosidenib
- Levomethadyl
- Lomitapide
- Lopinavir
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Lung or breathing problems (eg, interstitial lung disease, pneumonitis), history of—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with patient information leaflet. Read and follow the instructions carefully and make sure you understand them before taking this medicine. Ask your doctor if you have any questions.
Take this medicine any time before receiving amivantamab, when given on the same day.
You may take this medicine with or without food.
Swallow the tablet whole. Do not crush, cut, or chew it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For non-small cell lung cancer:
- Adults—240 milligrams (mg) once a day on the same day amivantamab is also given. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For non-small cell lung cancer:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is less than 12 hours, take the missed dose as soon as possible, and then go back to your regular schedule. If you miss a dose and it is more than 12 hours, skip the missed dose and take your next dose at the regular time.
If you vomit after taking a dose of this medicine, do not take an additional dose. Take your next dose at your usual time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for 3 weeks after your final dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 3 weeks after the last dose. If you think you have become pregnant, tell your doctor right away.
Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, or trouble breathing. These may be symptoms of serious blood clots (eg, deep vein thrombosis, pulmonary embolism).
Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, trouble breathing, or thickening of bronchial secretions. These may be symptoms of a lung problem (eg, interstitial lung disease, pneumonitis).
This medicine may cause serious skin reactions (eg, dermatitis acneiform). Check with your doctor right away if you have acne, blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps, outdoors and tanning beds for at least 2 months after the last dose.
Check with your doctor right away if you have eye redness, irritation, or pain. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
If you plan to have children, talk with your doctor before using this medicine. Some men and women who use this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Anxiety
- back pain
- bleeding gums
- blurred vision or blue-green halos seen around objects
- chest pain or tightness
- chills
- coughing up blood
- diarrhea
- difficulty swallowing
- dizziness or lightheadedness
- dry eyes
- eye redness, irritation, or pain
- fainting
- fever
- flushing
- headache
- increased menstrual flow or vaginal bleeding
- loss of taste or smell
- muscle or body aches
- nausea and vomiting
- nosebleeds
- pain, redness, or swelling around the fingernails
- pain, redness, or swelling in the arm or leg
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- sensitivity of the eyes to light
- sore throat
- stuffy or runny nose
- swelling
- trouble breathing
Less common
- General feeling of discomfort or illness
- thickening of bronchial secretions
Incidence not known
- Acne, pimples
- blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, scaly skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding after defecation
- decreased appetite
- muscle or bone pain
- stomach pain
- swelling or inflammation of the mouth
- trouble sleeping
- uncomfortable swelling around the anus
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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