Mobocertinib

(moe boe" ser' ti nib)

Brand Name(s): , Exkivity^®

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IMPORTANT WARNING:

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?

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.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

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.

What SPECIAL PRECAUTIONS should I follow?

Before taking mobocertinib,

• tell your doctor and pharmacist if you are allergic to mobocertinib, any other medications, or any of the ingredients in mobocertinib capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril , enalapril (Epaned, Vasotec, in Vaseretic), fosinopril, lisinopril (Prinivil, Qbrelis, Zestril, in Zestoretic), moexipril, perindopril, (in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril; angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), and valsartan (Diovan, in Diovan HCT, in Exforge, others); diuretics ('water pills'); efavirenz (Sustiva, in Atripla, in Symfi); hormonal contraceptives (birth control pills, patches, rings, implants, or injections); midazolam; rifampin (Rifadin, Rimactane); and sulfasalazine (Azulfidine). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with mobocertinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had asthma, emphysema, or other breathing problems (other than lung cancer); or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for 1 month after your final dose. Talk to your doctor about which methods you should use; hormonal contraceptives (birth control pills, patches, implants, rings, or injections) may not work well in women who are taking mobocertinib. If you are a male, you and your partner should use birth control during your treatment with mobocertinib and for 7 days after your final dose. If you or your partner become pregnant while taking mobocertinib, call your doctor immediately. Mobocertinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking mobocertinib and for 7 days after the final dose.
• you should know that mobocertinib often causes diarrhea, which can be severe. Call your doctor if you have diarrhea while taking mobocertinib. Your doctor may tell you to drink plenty of liquids, make changes in your diet, and take medication to control the diarrhea and prevent dehydration (loss of too much water from your body). Call your doctor immediately if you experience any of the following symptoms of dehydration: extreme thirst, dry mouth and/or skin, decreased urination, sunken eyes, or fast heartbeat.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

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?

Mobocertinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• mouth sores
• decreased appetite
• weight loss
• stomach pain
• heartburn
• rash
• dry skin or itching
• red, itchy, or irritated eyes
• blurry vision
• hair loss
• nail infection
• tiredness
• muscle or bone pain
• fatigue
• runny nose
• headache

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:

• diarrhea
• cough
• fever
• shortness of breath
• chest pain
• swelling of your ankles and feet

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 ([WEB]) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. [WEB]

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ([WEB]) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at [WEB]. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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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, 2023. 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, 2021.