Tablet core: Lactose monohydrate (derived from cow’s milk), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b),

Film coating: Hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), indigo carmine (E132) aluminum hydroxide

▼This drug is subject to additional monitoring. This triangle will enable rapid identification of new safety information. You can help by reporting any side effects that occur. To learn how to report side effects, see the end of Chapter 4.

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

GIOTRIF 30 mg film-coated tablets are dark blue, round, film-coated tablets. “T30” is printed on one side and the Boehringer Ingelheim company logo is printed on the other. It is marketed in cardboard boxes containing 28 tablets.

GIOTRIF contains the active ingredient afatinib. It works by blocking the activity of a group of proteins called the ErbB family (including EGFR [epidermal growth factor receptor, or ErbB1], HER2 (ErbB2), ErbB3, and ErbB4). EGFR is short for “epidermal growth factor receptor.”

These proteins play a role in the growth and spread of cancer cells and are affected by the gene changes (mutations) that cause them to appear. GIOTRIF can inhibit the growth and spread of cancer cells by blocking the activity of these proteins.

GIOTRIF is used in the first-line treatment of a special type of lung cancer (non-small cell locally advanced or metastatic lung cancer) and in the second-line treatment of people whose disease has progressed after one line of chemotherapy, in the treatment of cases where an authorized laboratory has shown a change (mutation) in a gene called the Epidermal Growth Factor Receptor (EGFR), until progression (progression of the disease). This group of patients should not have previously used drugs called tyrosine kinase inhibitors for these targets.

Instructions for proper use and dosage/frequency of administration

Always use your medicine exactly as your doctor tells you. If you are not sure, check with your doctor or pharmacist.

GIOTRIF treatment should be initiated and monitored by a physician experienced in administering cancer treatments.

Before starting GIOTRIF treatment, the change in the EGFR gene should be determined by checking.

Your doctor may adjust (decrease or increase) your dose until your disease progresses or you cannot tolerate the medication. Your doctor will determine the appropriate dose for you, taking into account any side effects that may occur.

Like all medicines, GIOTRIF can cause side effects, but not everyone gets these side effects.

If any of the following occur, stop using GIOTRIF and IMMEDIATELY inform your doctor or go to the emergency department of your nearest hospital:

If you experience allergic or anaphylactic reactions (side effects) (skin symptoms such as hives, swelling, itching, redness, respiratory symptoms such as throat congestion, shortness of breath, cough), stop taking the medicine and immediately contact your doctor or the emergency department of the nearest hospital.

These are all very serious side effects.

If you have one of these, it means you are allergic to GIOTRIF. You may need emergency medical attention or hospitalization.

⚠️ Disclaimer: The information provided on this website is for informational purposes only and does not substitute professional medical advice. Always consult a healthcare provider before using any medication.