Gilotrif (afatinib)

Gilotrif® is a targeted therapy that is used to treat some non-small cell lung cancers (NSCLC) that have a certain non-resistant EGFR (epidermal growth factor receptor) mutation, specifically the exon 19 deletion or exon 21 substitution mutation. EGFR mutation is determined by biomarker tests (molecular testing) conducted on a biopsy sample of the tumor. Gilotrif 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, Gilotrif may shrink the cancer or slow the cancer’s progression.1,2

Gilotrif is used to treat NSCLC that has spread to other parts of the body (metastatic) that are positive for EGFR mutation (exon 19 deletion or exon 21 substitution) prior to other treatment. Gilotrif may also be used for NSCLC that is squamous type and has spread (metastasized) after platinum-based chemotherapy has already been used.1

About EGFR Mutations

An estimated 10% 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 female patients who have never smoked (patients are 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

Taking Gilotrif

Gilotrif is a pill that is taken by mouth on an empty stomach once daily. It should be taken at least 1 hour before a meal or 2 hours after a meal and may be taken with a glass of water. The dosage of Gilotrif is determined by several factors, including the patient’s general health, kidney function, and ongoing response to treatment.2

Side Effects of Gilotrif

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 30% of patients taking Gilotrif include diarrhea, mouth sores, infection of the nails (paronychia), dry mouth, and a skin condition resembling acne. Less common side effects experienced in 10-29% of patients receiving Gilotrif 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. Side effects from Gilotrif are almost always reversible and tend to go away after treatment is complete. This is not a complete list of adverse effects.

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 Gilotrif should talk to their doctor about other medications, herbal remedies, and any supplements they are taking, as well as any other health conditions. Patients should talk to their doctor before receiving immunizations or vaccinations while taking Gilotrif to make sure they are appropriate. Exposure to sunlight should be limited, as Gilotrif can make the skin more sensitive to sunlight. Patients who are pregnant or may become pregnant during treatment should discuss their condition with their doctor prior to starting Gilotrif, as it may be hazardous to the fetus. It is not known whether Gilotrif passes into breast milk, and patients should not breastfeed while taking Gilotrif.2

Written by: Emily Downward | Last reviewed: October 2018.
View References
  1. Gilotrif product website, Boehringer Ingelheim. Accessed online on 9/27/16 at
  2. Chemocare. Accessed online on 9/27/16 at
  3. National Cancer Institute. Accessed online on 8/1/16 at
  4. My Cancer Genome. Accessed online on 8/11/16 at