Vizimpro is a prescription medicine used to treat non-small cell lung cancer that has spread to other parts of the body (metastasised).

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

It is not known if Vizimpro is safe and effective in children.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You may need to have a negative pregnancy test before starting this treatment.

Do not use Vizimpro if you are pregnant.Dacomitinib could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 17 days after your last dose. Tell your doctor if you become pregnant.

Do not breast-feed while using this medicine, and for at least 17 days after your last dose.

To make sure Vizimprois safe for you, tell your doctor if you have ever had:

• frequent diarrhea; or

• breathing problems (other than lung cancer).

Take Vizimpro exactly as prescribed by your doctor. Your doctor will perform a special test to 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.

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

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

Drink plenty of liquids while you are taking dacomitinib.

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

If you have diarrhea while taking Vizimpro: 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

You may need to have a negative pregnancy test before starting this treatment.

Do not use Vizimpro if you are pregnant.Dacomitinib could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 17 days after your last dose. Tell your doctor if you become pregnant.

Do not breast-feed while using this medicine, and for at least 17 days after your last dose.

To make sure Vizimprois safe for you, tell your doctor if you have ever had:

• frequent diarrhea; or

• breathing problems (other than lung cancer).

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.

Vizimpro 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 to Vizimpro: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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 Vizimpro side effects 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.

Some medicines can make dacomitinib much less effective when taken at the same time. If you take any of the following medicines, take your Vizimpro dose 6 hours before or 10 hours after you take the other medicine:

• an antacid; or

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

Other drugs may interact with dacomitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.