Dacomitinib is used to treat non-small cell lung cancer that has spread to other parts of the body.

Dacomitinib is given only if your tumor has a specific genetic marker (an abnormal "EGFR" gene).

Dacomitinib may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Your doctor will make sure you have the correct tumor type to be treated with dacomitinib.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Drink plenty of liquids while you are taking dacomitinib.

If you vomit shortly after taking dacomitinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Dacomitinib can cause severe diarrhea, which can be life-threatening if it leads to dehydration or infection.

If you have diarrhea while taking dacomitinib: Call your doctor right away. You may need to start taking anti-diarrhea medicine such as loperamide (Imodium) to quickly treat diarrhea.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

45 mg orally once a day until disease progression or unacceptable toxicity

Use: For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test

Tell your doctor if you have ever had:

• frequent diarrhea; or

• breathing problems (other than lung cancer).

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use birth control while using dacomitinib and for at least 17 days after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using dacomitinib, and for at least 17 days after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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

Dacomitinib can cause skin reactions. Use a skin moisturizer and avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dacomitinib may cause serious side effects. Call your doctor at once if you have:

• new or worsening breathing problems (chest pain, wheezing, cough, feeling short of breath);

• fever;

• severe or ongoing diarrhea;

• swelling, redness, or infection under or around your fingernails or toenails; or

• a severe skin reaction--dry skin, redness, rash, acne, itching, peeling or blistering.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of dacomitinib may include:

• diarrhea, loss of appetite;

• weight loss;

• rash, itching, dry skin;

• eye redness, dryness, or itching;

• hair loss;

• problems with your nails;

• mouth sores, mouth pain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take your dacomitinib dose 6 hours before or 10 hours after taking any of the following:

• an antacid; or

• a stomach acid reducer (such as Tagamet, Pepcid, Zantac).

This list is not complete. Other drugs may affect dacomitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.