Gilotrif (afatinib)

Reviewed by: HU Medical Review Board | Last reviewed: July 2022 | Last updated: July 2022

Afatinib (Gilotrif®) is used to treat some non-small cell lung cancers (NSCLC) that have spread to other parts of the body (metastatic) that are positive for non-resistant EGFR mutation. EGFR mutation is determined by biomarker tests (molecular testing) conducted on a biopsy sample of the tumor. Afatinib is an EGFR inhibitor and is also classified as a tyrosine kinase inhibitor. It is designed to block the activating sites (tyrosine kinases) of several proteins within the cancer cell. These proteins can stimulate cancer growth when the tumor has an EGFR mutation. By blocking the action of the proteins, afatinib may shrink the cancer or slow the cancer’s progression.1,2

Afatinib is used to treat NSCLC that has spread to other parts of the body (metastatic) that are positive for non-resistant EGFR mutation prior to other treatment. Afatinib may also be used for NSCLC that is squamous type and has spread (metastasized), that has gotten worse after platinum-based chemotherapy has already been used.1

About EGFR mutations

It is estimated that approximately 10-20 percent of patients with non-small cell lung cancer (NSCLC) in the United States have a tumor mutation associated with EGFR. EGFR mutations are most often found in tumors in patients who have never smoked (patients may be considered “never smokers” if they have smoked less than 100 cigarettes in their lifetime). The tumors are likely to be adenocarcinoma. However, EGFR mutations are not exclusive to this type of NSCLC or non-smokers – mutations have also been found in smokers and in other tumor types.3,4

Receiving afatinib

Afatinib is a pill that is taken by mouth. The dosage of afatinib is determined by several factors, including the patient’s general health, kidney function, and ongoing response to treatment. Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their afatinib regimen.2

Side effects of afatinib

Gilotrif may cause side effects, and in some cases, these side effects can be severe. Any side effects should be reported to a health care professional. Side effects experienced in greater than approximately 30 percent of patients taking afatinib include diarrhea, mouth sores, infection of the nails (paronychia), dry mouth, and a skin condition resembling acne. Less common side effects experienced in approximately 10-29 percent of patients receiving afatinib include decreased appetite, itching, weight loss, nose bleeds, bladder infection (cystitis), inflammation of the lips (cheilitis), fever, low potassium, pink eye (conjunctivitis), runny nose, and elevated liver enzymes. For most people, side effects from afatinib are reversible and tend to go away after treatment is complete. This is not an exhaustive list of all potential side effects of afatinib. Talk to your healthcare provider or pharmacist for further information.

Patients experiencing a fever of 100.4°F (38°C) or higher, shortness of breath or trouble breathing, chest pain, or heart palpitations (racing or pounding heart beat) should contact a health care professional immediately.2


Patients receiving afatinib should talk to their doctor about any other medications (prescription and over-the-counter), herbal remedies, and any supplements they are taking, as well as any other health conditions. Exposure to sunlight should be limited, as afatinib can make the skin more sensitive to sunlight. If you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed, talk with your doctor. Afatinib can cause harm to a developing fetus and should not be taken by women who are pregnant. While taking afatinib, females who can become pregnant should use contraceptives during treatment and for a period of time after completing treatment (patients should discuss appropriate birth control methods, and how long they need to use them, with their doctor). Females should not breastfeed during afatinib treatment and for a period of time following the final dose (patients should discuss breastfeeding considerations with their doctor).2

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