Mobocertinib Oral Capsules

What is this medication?

MOBOCERTINIB (moe boe ser ti nib) targets proteins in cancer cells and stops the cancer cells from growing. It treats certain types of lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): EXKIVITY

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• high or low levels of electrolytes, such as magnesium, potassium, or sodium in your blood
• irregular heartbeat or rhythm
• lung disease
• an unusual or allergic reaction to mobocertinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Your health care provider may change your dose or tell you to stop taking this medicine if you get side effects. Do not change your dose or stop taking it unless your health care provider tells you to.

Do not cut, crush or chew this medicine. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food.

Do not take this medicine with grapefruit juice.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 6 hours late. If it is more than 6 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• birth control pills
• certain medicines for fungal infections like ketoconazole or itraconazole
• efavirenz
• grapefruit juice
• midazolam
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. It may be some time before you see the benefit from this medicine.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 1 month after stopping it. Hormone forms of birth control may not work as well with this medicine. Talk to your health care provider about other forms of birth control. Men should not father a child while taking this medicine and for 1 week after stopping it. There is a potential for serious side effects to an unborn child. Tell your health care provider right away if you think you might be pregnant. Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.

This medicine may make it more difficult to get pregnant or father a child. Talk to your health care provider if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash; itching or hives; swelling of the face, lips, or tongue)
• cough
• diarrhea
• fever
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• heart failure (sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired)

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• bone pain
• decreased appetite
• dry skin
• mouth sores
• muscle pain
• nausea
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.