Class: Biological Therapy

Generic Name:Afatinib
Trade Name: Gilotrif®

For which conditions is this drug approved? Gilotrif is approved for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have the following epidermal growth factor receptor (EGFR) traits: exon 19 deletions or exon 21 (L858R) substitution mutations. Exons are the protein-coding DNA sequence of a gene.

What is the mechanism of action? Gilotrif targets EGFR, a protein located on the surface of many cancer cells that is involved in cancer growth. By blocking the EGFR pathway, Gilotrif helps keep cancer cells from growing.

How is Gilotrif typically given (administered)?Gilotrif is given orally once daily. It should be taken on an empty stomach—at least one hour before or two hours after a meal.

How are patients typically monitored?All patients will need to undergo liver function monitoring periodically while taking Gilotrif. Patients with moderate to severe renal (kidney) impairment should be closely monitored.

What are the common (occur in 30% or more of patients) side effects of treatment with Gilotrif?

  • Diarrhea
  • Inflammation of mouth and lips (stomatitis)
  • Rash/skin lesions (dermatitis acneiform)
  • Dry skin
  • Finger or toenail infection

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Gilotrif?

  • Inflammation of the lips (cheilitis)
  • Itching
  • Inflammation of the bladder (cystitis)
  • Decreased appetite
  • Nose bleed
  • Runny nose
  • Decreased weight
  • Fever
  • Pink eye (conjunctivitis)

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects? Take Gilotrif only as directed (once daily on an empty stomach). If you miss a dose, do not take the missed dose within 12 hours of the next planned dose.

Are there any special precautions patients should be aware of before starting treatment?

  • Gilotrif can harm an unborn baby. Women of childbearing age should use highly effective contraception during treatment and for at least two weeks after their final dose of Gilotrif.
  • Nursing mothers should not nurse while taking Gilotrif.
  • To reduce risk or severity of skin disorders, patients should minimize sun exposure as well as wear protective clothing and use sunscreen while taking Gilotrif. 

When should patients notify their physician?

  • If you experience side effects that are bothersome or don’t go away
  • If you become pregnant or suspect you may be pregnant while taking Gilotrif
  • If you experience symptoms of a liver problem, including: yellowing of the skin or whites of eyes, dark brown urine, pain on the right side of stomach, bleeding or bruising more easily than normal, or lethargy
  • If you experience eye problems, including: pain, swelling, redness, blurred vision, or other vision changes
  • If you experience new or worsening lung symptoms or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever
  • If you experience diarrhea—seek medical attention immediately for severe or persistent diarrhea
  • If you experience signs of a heart problem, including: new onset or worsening shortness of breath or exercise intolerance, cough, fatigue, swelling of the ankles/legs, palpitations, or sudden weight gain.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.