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Mobocertinib is no longer commercially available in the U. S. See the FDA website (http://www.accessdata.fda.gov/scripts/cder/daf/) for information on drugs that have been discontinued.
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
Mobocertinib may cause QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death). Tell your doctor if you or anyone in your family has or has ever had long QT syndrome (an inherited condition in which a person is more likely to have QT prolongation) or you have or have ever had low levels of potassium or magnesium in your blood, an irregular heartbeat, or heart failure. Tell your doctor and pharmacist if you are taking any of the following medications: amiodarone (Nexterone, Pacerone); azithromycin (Zithromax); ciprofloxacin (Cipro); clarithromycin; disopyramide (Norpace); dofetilide (Tikosyn); dronedarone (Multaq); erythromycin (E.E.S., Eryc, Ery-tab, Erythrocin); fluconazole (Diflucan); certain medications for HIV such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); haloperidol (Haldol); ibutilide (Corvert); itraconazole (Sporanox, Tolsura); ketoconazole; levofloxacin; moxifloxacin; ondansetron (Zofran); procainamide; quinidine (in Nuedexta); sotalol (Betapace, Sorine, Sotylize); or voriconazole (Vfend). If you experience any of the following symptoms, call your doctor immediately: fast, pounding, or irregular heartbeat; dizziness; lightheadedness; or fainting.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests, such as blood tests and electrocardiograms (EKGs, tests that record the electrical activity of the heart) before and during your treatment to be sure that it is safe for you to take mobocertinib.
Talk to your doctor about the risks of taking mobocertinib.
WHY is this medicine prescribed?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
Mobocertinib is used to treat a certain type of non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has spread to other parts of the body either during or after treatment with platinum chemotherapy medications. Mobocertinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.
HOW should this medicine be used?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
Mobocertinib comes as a capsule to take by mouth. It is usually taken once daily with or without food. The length of your treatment depends on how well this medication works for you, and the side effects that you experience. Take mobocertinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mobocertinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not open, chew, crush, or dissolve them.
If you vomit after taking mobocertinib, do not take another dose. Continue your regular dosing schedule.
Your doctor may decrease your dose, or interrupt or discontinue your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take mobocertinib even if you feel well. Do not stop taking mobocertinib without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medication?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
Before taking mobocertinib,
What SPECIAL DIETARY instructions should I follow?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
Do not eat grapefruit or drink grapefruit juice while taking this medication.
What should I do IF I FORGET to take a dose?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
If you miss a dose by less than 6 hours, take the missed dose as soon as you remember it and then take the next dose at the scheduled time. However, if you miss a dose by more than 6 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
Mobocertinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section and call your doctor immediately or get emergency medical treatment:
Mobocertinib may 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://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.
What should I know about STORAGE and DISPOSAL of this medication?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
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).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
What OTHER INFORMATION should I know?
Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.
Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with mobocertinib.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: October 15, 2023.