Dacomitinib (dak-oh-MI-ti-nib)

Treats non-small cell lung cancer.

Brand Name(s):

Vizimpro

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule.
• If you vomit after taking a dose, take the next dose at your regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dacomitinib works. Tell your doctor if you are using a proton pump inhibitor (PPI).
• Take this medicine at least 6 hours before or 10 hours after using an antacid or H2 blocker (including cimetidine, ranitidine).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment with this medicine and for at least 17 days after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 17 days after the last dose.
• 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.
• Tell your doctor if you have kidney disease, liver disease, or lung or breathing problems.
• This medicine may cause the following problems:
  • Interstitial lung disease or pneumonitis, which may be life-threatening
  • Serious skin reactions
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Apply moisturizer while using this medicine. Wear sunscreen and protective clothing before going outside. Do not use sunlamps or tanning beds.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash, sensitivity of the skin to sunlight
• Severe diarrhea, nausea, vomiting, stomach pain
• Troubled breathing, chest pain, cough, fever

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Dry skin
• Pain in the arms or legs
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088