Dacomitinib is used to treat a certain type of non-small-cell lung cancer (NSCLC) that has spread to other parts of the body. Dacomitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Dacomitinib comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take dacomitinib 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 dacomitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit after you take dacomitinib, do not immediately take another dose. Continue your regular dosing schedule.

Your doctor may temporarily or permanently stop your treatment or decrease your dose if you experience certain side effects of dacomitinib. Tell your doctor how you are feeling during your treatment. Continue to take dacomitinib even if you feel well. Do not stop taking dacomitinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

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

Before taking dacomitinib,

• tell your doctor and pharmacist if you are allergic to dacomitinib, any other medications, or any of the ingredients in dacomitinib tablets. 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 any of the following: antidepressants such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), imipramine (Tofranil), paroxetine (Paxil, Pexeva), and venlafaxine (Effexor); antipsychotics such as aripiprazole (Abilify), haloperidol (Haldol), risperidone (Risperdal), and thioridazine; atomoxetine (Strattera); beta blockers such as carvedilol (Coreg), metoprolol (Dutoprol), and timolol; codeine; dextromethorphan (found in many cough medications; in Nuedexta); flecainide (Tambocar); mexiletine; ondansetron (Zofran, Zuplenz); oxycodone (Oxaydo, Xtampza ER); propafenone (Rythmol SR); proton-pump inhibitors such as dexlanspoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex); tamoxifen (Soltamox); and tramadol (Conzip, Ultram). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid, in Duexis), nizatidine (Axid), or ranitidine (Zantac), take dacomitinib at least 6 hours before or at least 10 hours after taking one of these medications.
• tell your doctor if you have frequent diarrhea episodes, lung disease, breathing problems other than lung cancer, or liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. You must take a pregnancy test before starting treatment. You should not become pregnant while you are taking dacomitinib. You should use a reliable method of birth control while taking dacomitinib and for at least 17 days after your final dose. If you become pregnant while taking dacomitinib, call your doctor immediately. Dacomitinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking dacomitinib and for 17 days after your final dose.
• plan to use a moisturizer, avoid unnecessary or prolonged exposure to sunlight, and to wear protective clothing, sunglasses, and sunscreen. Dacomitinib may make your skin sensitive to sunlight.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• weight loss
• loss of appetite
• mouth sores
• infection of the skin around the fingernails or toenails
• hair loss
• cough
• lack of energy
• difficulty falling asleep or staying asleep
• red or swollen eyes (“pink eye”)
• taste changes
• vomiting

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• diarrhea
• shortness of breath, cough, and fever
• dry skin, redness, rash, acne, itchy skin, and peeling or blistering of your skin
• chest pain

Dacomitinib 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).

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. http://www.upandaway.org

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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://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.

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with dacomitinib.

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.

• Vizimpro^®