Gilotrif is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Gilotrif is used to treat a certain type of non-small cell lung cancer that has spread to other parts of the body. It is used for this condition only if your tumor has a specific genetic marker for which your doctor will test.

Gilotrif is also used to treat squamous non-small cell lung cancer that has spread to other parts of the body after other cancer medicine has been tried without successful treatment.

Minimize sun exposure with protective clothing and use of sunscreen while taking Gilotrif tablets.

Diarrhea occurs in nearly all patients who receive Gilotrif. Severe diarrhea may result in dehydration and renal impairment. Call your doctor if you are sick with severe diarrhea, or diarrhea lasting longer than 2 days.

Call your doctor at once if you experience eye pain, swelling, redness, blurred vision, or other vision change.

Call your doctor at once if you experience any of the following: new onset or worsening shortness of breath or exercise intolerance, cough, fatigue, swelling of the ankles/legs, palpitations, or sudden weight gain.

Take Gilotrif tablets exactly as prescribed by your doctor. Your doctor will perform a blood test to make sure afatinib is the right treatment for your condition.

Gilotrif is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Gilotrif on an empty stomach, at least 1 hour before or 2 hours after a meal.

Gilotrif can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may be given medications to prevent or quickly treat diarrhea.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking Gilotrif. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor.

Call your doctor if you are sick with severe diarrhea, or diarrhea lasting longer than 2 days. You may need to stop taking this medicine for a short time.

While using Gilotrif, you may need frequent blood tests.

Store the tablets in their original container at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Throw away any tablets not used before the expiration date on the medicine label.

Usual Adult Dose for Non-Small Cell Lung Cancer:

40 mg orally once a day until disease progression or intolerance by the patient

Comments:
-Take on an empty stomach at least 1 hour before or 2 hours after a meal.
-Epidermal growth factor receptor (EGFR) mutation status should be established prior to therapy initiation.
-Do not take a missed dose within 12 hours of the next dose.

Uses:
-EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an approved test.
-Previously Treated, Metastatic Squamous NSCLC: For the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

You should not use Gilotrif if you are allergic to afatinib.

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

• kidney disease;

• liver disease;

• heart disease;

• breathing problems or lung disease other than cancer; or

• vision problems, very dry eyes, or if you wear contact lenses.

Gilotrif may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks after your last dose. Tell your doctor if you become pregnant.

Do not not breastfeed while using this medicine and for 2 weeks after your last dose.

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

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

Afatinib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

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

Stop using Gilotrif and call your doctor at once if you have:

• new or worsening cough, fever, or trouble breathing;

• severe or ongoing diarrhea (lasting 2 days or longer);

• severe skin reaction that causes blistering and peeling;

• pain, redness, numbness, and peeling skin on your hands or feet;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• eye problems - eye pain or redness, blurred vision, watery eyes, feeling like something is in your eye, increased sensitivity to light;

• liver problems - stomach pain (upper right side), easy bruising or bleeding, feeling tired, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• heart problems - pounding heartbeats or fluttering in your chest, shortness of breath (even with mild exertion), swelling in your legs or ankles, rapid weight gain.

Common Gilotrif side effects may include:

• mild diarrhea for 1 day or less;

• nausea, vomiting, loss of appetite;

• mouth sores;

• acne, itching, dry skin; or

• redness, pain, swelling, or other signs of infection around your fingernails or toenails.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with afatinib, 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.