Dacomitinib Tablets

What is this medication?

DACOMITINIB (DAK oh MI ti nib) treats lung cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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

COMMON BRAND NAME(S): Vizimpro

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

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

• Kidney disease
• Liver disease
• Lung or breathing disease, such as asthma or COPD
• Skin conditions or sensitivity
• An unusual or allergic reaction to dacomitinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time each day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take this medication with or without food. If it upsets your stomach, take it with food. You should always take it the same way each time. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication 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 vomit or miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Pimozide
• Thioridazine

This medication may interact with the following:

• Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, lansoprazole
• Dextromethorphan

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?

Your condition will be monitored carefully while you are receiving this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 17 days after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 17 days after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for at least 17 days after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Severe or prolonged diarrhea

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

• Change in nail shape, thickness, or color
• Dry skin
• Hair loss
• Loss of appetite with weight loss
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat

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 25 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

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

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

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.