Description
Mobocertinib is used to treat non-small cell lung cancer (NSCLC) that has spread (metastatic) or cannot be removed by surgery or radiation (locally advanced) in patients who have an abnormal epidermal growth factor receptor (EGFR) gene (exon 20 insertion mutations) and have received other cancer medicines (eg, platinum) but did not work well. Your doctor will perform a test before you take this medicine.
Mobocertinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.
This medicine is available only with your doctor's prescription.
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 mobocertinib 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 mobocertinib in the elderly. However, elderly patients are more likely to have serious unwanted effects, which may require caution in patients receiving this medicine.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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
- Adagrasib
- Alfentanil
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Amprenavir
- Anagrelide
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Axitinib
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Berotralstat
- Boceprevir
- Bosentan
- Bosutinib
- Brigatinib
- Buprenorphine
- Buserelin
- Carbamazepine
- Cenobamate
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clindamycin
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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:
- Electrolyte imbalance (high or low calcium, magnesium, potassium, or sodium) or
- Heart problems (eg, cardiomyopathy, heart failure) or
- Heart rhythm problems (eg, long QT syndrome) or
- Lung or breathing problems (eg, interstitial lung disease, pneumonitis), history of—Use with caution. May make these conditions worse.
- Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving 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 exactly 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. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
You may take this medicine with or without food. Take the medicine at the same time each day.
Swallow the capsule whole. Do not open, chew, or dissolve its contents.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
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 (capsules):
- For non-small cell lung cancer:
- Adults—160 milligrams (mg) once a day. 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 a dose is missed by more than 6 hours, do not take an extra dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose.
If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular 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 a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 month after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 1 week 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 chest pain or discomfort, irregular or slow heart rate, fainting, or trouble breathing. These maybe symptoms of serious heart rhythm problems (eg, QT prolongation, torsades de pointes).
This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.
Check with your doctor right away if you have chest pain, discomfort, or tightness, decreased urine output, dilated neck veins, dizziness, faintness, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain. These may be symptoms of serious heart problems (eg, congestive heart failure, cardiomyopathy).
This medicine may cause diarrhea, and in some cases it can be severe. Your doctor will ask you to take medicine to treat first signs of diarrhea or to drink plenty of fluids.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan 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
- Agitation
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody eye
- blurred vision or blue-green halos seen around objects
- coma
- confusion
- decreased urine output
- depression
- diarrhea
- dizziness
- dry eyes
- fainting
- fast, pounding, or irregular heartbeat or pulse
- headache
- hostility
- irregular heartbeat recurrent
- irritability
- lethargy
- muscle twitching
- nausea
- nervousness
- palpitations
- pounding in the ears
- rapid weight gain
- redness, swelling, and/or itching of the eyelid
- seizures
- sensitivity of the eyes to light
- stupor
- swelling of the face, ankles, or hands
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Less common
- Chest pain or discomfort
- chills
- cough
- dilated neck veins
- fever
- general feeling of discomfort or illness
- irregular breathing
- swelling of the face, fingers feet, or lower legs
- thickening of bronchial secretions
- trouble breathing
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
- Acid or sour stomach
- belching
- body aches or pain
- burning, numbness, tingling, or painful sensations
- cracked lips
- decreased appetite
- difficulty in moving
- ear congestion
- heartburn
- indigestion
- loosening of the fingernails
- loss or thinning of the hair
- loss of voice
- muscle or bone pain
- pain in the arms or legs
- rash
- redness or soreness around the fingernails
- sneezing
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach discomfort, upset, or pain
- stuffy or runny nose
- swelling or inflammation of the mouth
- tender, swollen glands in the neck
- trouble in swallowing
- unsteadiness or awkwardness
- voice changes
- vomiting
- weakness in the arms, hands, legs, or feet
Less common
- Redness, swelling, pain of the skin
- scaling of the skin on the hands and feet
- ulceration of the skin
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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