Posted on December 2nd, 2008 by

Class: Biologic therapy

Generic Name: Gefitinib (je-FI-ti-nib)
Trade Name: Iressa®

For which conditions is this drug approved? Gefitinib is FDA approved for the treatment of locally advanced or metastatic non-small cell lung cancer that has progressed or not responded following treatment with platinum and taxanes-based therapies. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Gefitinib is classified as an epidermal growth factor receptor inhibitor. The epidermal growth factor receptor pathway is involved in regulating growth and replication of a cell. In many cancer cells, this pathway is abnormal and provides continual growth stimulation of a cell. Gefitinib blocks part of the epidermal growth factor receptor pathway so that the cellular growth signals are inhibited.

How is gefitinib typically given (administered)? Gefitinib is in the form of a tablet and is taken orally, typically once per day and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while being treated with gefitinib. Physical examinations, scans or other measures may be performed to assess side effects and response to therapy. Blood may be drawn to monitor functions of some organs, such as the liver. In addition, patients will have their lungs monitored, as a rare but serious side effect affecting the lungs may occur. If patients experience a sudden shortness of breath, cough and/or fever, they should contact their healthcare provider.

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

• Skin rash or acne
• Diarrhea

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

• Nausea and vomiting
• Loss of appetite
• Itching
• Dry skin

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?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Eat small meals frequently to help alleviate nausea.

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

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should inform their physician if they are taking warfarin as they may require extra monitoring and dose adjustment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• If an oral dose is missed, do not double up on doses.  Patients should contact their physician in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.

When should patients notify their physician?

• Sudden onset of shortness of breath, cough and/or fever
• Any change in breathing
• Persistent or extreme diarrhea
• Persistent or extreme nausea and vomiting
• Eye pain or eye irritation
• Severe rash
• Allergic reaction (hives, swelling of throat, mouth, tongue, lips)

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.

Copyright © 2016 CancerConnect Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Tags: Biological Therapy, I

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