Mobocertinib (Oral route)

Pronunciation:

moe-boe-SER-ti-nib

Brand Names:

Exkivity

Dosage Forms:

Capsule

Warnings:

Oral route(Capsule)

Mobocertinib can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation.Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with mobocertinib, which may further prolong the QTc.Withhold, reduce the dose, or permanently discontinue mobocertinib based on the severity of QTc prolongation .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
Axitinib
Azithromycin
Bedaquiline
Berotralstat
Boceprevir
Bosentan
Bosutinib
Brigatinib
Buprenorphine
Buserelin
Carbamazepine
Cenobamate
Ceritinib
Chloroquine
Chlorpromazine
Ciprofloxacin
Citalopram
Clarithromycin
Clindamycin
Clofazimine
Clomipramine
Clothiapine
Clozapine
Cobicistat
Cobimetinib
Colchicine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desogestrel
Deutetrabenazine
Dexmedetomidine
Dienogest
Dihydroergotamine
Diltiazem
Dipyrone
Disopyramide
Docetaxel
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Dronedarone
Droperidol
Drospirenone
Duvelisib
Ebastine
Efavirenz
Elagolix
Encorafenib
Entrectinib
Enzalutamide
Ergotamine
Eribulin
Erythromycin
Escitalopram
Estetrol
Estradiol
Ethinyl Estradiol
Ethynodiol
Etonogestrel
Etrasimod
Etravirine
Everolimus
Famotidine
Fedratinib
Felbamate
Fentanyl
Fexinidazole
Fingolimod
Flecainide
Flibanserin
Fluoxetine
Formoterol
Fosamprenavir
Foscarnet
Fosnetupitant
Fosphenytoin
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Gestodene
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Idelalisib
Iloperidone
Imatinib
Imipramine
Indinavir
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Lapatinib
Lefamulin
Lenvatinib
Letermovir
Leuprolide
Levofloxacin
Levomethadyl
Levonorgestrel
Lofexidine
Lomitapide
Lonafarnib
Lorlatinib
Lumacaftor
Lumefantrine
Macimorelin
Mavacamten
Medroxyprogesterone
Mefloquine
Mestranol
Methadone
Methotrimeprazine
Metronidazole
Midostaurin
Mifepristone
Mitotane
Mizolastine
Modafinil
Moricizine
Moxifloxacin
Nafarelin
Nafcillin
Nefazodone
Nelfinavir
Neratinib
Netupitant
Nilotinib
Nomegestrol
Norelgestromin
Norethindrone
Norfloxacin
Norgestimate
Norgestrel
Octreotide
Ofloxacin
Olanzapine
Olaparib
Oliceridine
Omaveloxolone
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxycodone
Paclitaxel
Pacritinib
Paliperidone
Panobinostat
Papaverine
Paritaprevir
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Phenobarbital
Phenytoin
Pimavanserin
Pipamperone
Pitolisant
Ponesimod
Primidone
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Quizartinib
Ranolazine
Relugolix
Ribociclib
Rifabutin
Rifampin
Rifapentine
Risperidone
Ritlecitinib
Ritonavir
Ruxolitinib
Schisandra sphenanthera
Segesterone
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Siponimod
Sirolimus
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sonidegib
Sorafenib
Sotalol
St John's Wort
Sufentanil
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tamoxifen
Telaprevir
Telavancin
Telithromycin
Telotristat Ethyl
Temsirolimus
Tetrabenazine
Tolterodine
Tolvaptan
Toremifene
Tramadol
Trazodone
Triclabendazole
Trimipramine
Triptorelin
Troleandomycin
Tucatinib
Ulipristal
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Voxelotor
Zanubrutinib
Zotepine
Zuclopenthixol

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 of This Medicine:

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.

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 While Using This Medicine:

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 of This Medicine:

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.

Last Updated: 4/24/2024

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