"The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, a"...
Iressa Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Iressa (gefitinib) Tablets is a chemotherapy medication used to treat non-small cell lung cancer. It is available in generic form. Common side effects of Iressa include nausea, vomiting, loss of appetite, diarrhea, rash, dryness, itching, acne, and weakness.
The recommended daily dose of Iressa is 250 mg. Iressa must be administered under a doctor's supervision. Warfarin, Rifadin, Dilantin, Nizoral, Sporanox, and stomach acid reducers may interact with Iressa. Tell your doctor all medications you take. Before taking Iressa tell your doctor if you have decreased liver function. Do not take Iressa if you are pregnant or breastfeeding.
Our Iressa (gefitinib) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Iressa in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects from gefitinib, contact your doctor immediately:
- an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- lung problems (difficulty breathing, shortness of breath, increased coughing, fever, or chest pain);
- severe or persistent nausea, vomiting, loss of appetite, or diarrhea; or
- eye pain or irritation.
Other, less serious side effects may be more likely to occur. Continue taking gefitinib and talk to your doctor if you experience:
- mild to moderate nausea, vomiting, loss of appetite, or diarrhea;
- skin rash, dryness, itching, or acne; or
Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with gefitinib. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Iressa (Getfitinib) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Iressa Overview - Patient Information: Side Effects
Diarrhea, rash, acne, nausea, vomiting, loss of appetite, nail problems, hair loss, red/sore mouth or throat, or unusual weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist immediately.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Persistent nausea, vomiting, diarrhea, or loss of appetite may result in a serious loss of body water (dehydration) and kidney problems. Contact your doctor promptly if you notice any symptoms of dehydration, such as: unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, dizziness/lightheadedness.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding (coughing up blood, blood in urine), eye irritation/pain, swelling of the ankles/feet.
Gefitinib may cause rare (possibly fatal) lung disease (interstitial lung disease-ILD). Tell your doctor immediately if you develop trouble breathing, cough or fever.
If you have persistent diarrhea or skin rashes contact your doctor. Your doctor may temporarily stop gefitinib (for up to 14 days) which may help reverse those side effects. Treatment is then resumed with the same dosage.
An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: severe rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Iressa (Getfitinib)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Iressa FDA Prescribing Information: Side Effects
The safety database includes 941 patients from clinical trials and approximately 23,000 patients in the Expanded Access Program.
Table 3 includes drug-related adverse events with an incidence of ≥ 5% for the 216 patients who received either 250 mg or 500 mg of IRESSA (getfitinib) monotherapy for treatment of NSCLC. The most common adverse events reported at the recommended 250 mg daily dose were diarrhea, rash, acne, dry skin, nausea, and vomiting (see PRECAUTIONS - INFORMATION FOR PATIENTS and DOSAGE AND ADMINISTRATION - Dosage Adjustment sections). The 500 mg dose showed a higher rate for most of these adverse events.
Table 4 provides drug-related adverse events with an incidence of ≥ 5% by CTC grade for the patients who received the 250 mg/day dose of IRESSA (getfitinib) monotherapy for treatment of NSCLC. Only 2% of patients stopped therapy due to an adverse drug reaction (ADR). The onset of these ADRs occurred within the first month of therapy.
Table 3 - Drug-Related Adverse Events With an Incidence of
≥ 5% in either 250 mg or 500 mg Dose Group
|Drug-related adverse eventa||Number (%) of Patients|
|Diarrhea||49 (48)||76 (67)|
|Rash||44 (43)||61 (54)|
|Acne||25 (25)||37 (33)|
|Dry skin||13 (13)||30 (26)|
|Nausea||13 (13)||20 (18)|
|Vomiting||12 (12)||10 (9)|
|Pruritus||8 (8)||10 (9)|
|Anorexia||7 (7)||11 (10)|
|Asthenia||6 (6)||5 (4)|
|Weight loss||3 (3)||6 (5)|
|a A patient may have had more than 1 drug-related adverse event.|
Table 4 - Drug Related Adverse Events ≥ 5% at 250 mg dose
by Worst CTC Grade (n=102)
|Adverse Event||% of Patients|
Other adverse events reported at an incidence of <5% in patients who received either 250 mg or 500 mg as monotherapy for treatment of NSCLC (along with their frequency at the 250 mg recommended dose) include the following: peripheral edema (2%), amblyopia (2%), dyspnea (2%), conjunctivitis (1%), vesiculobullous rash (1%), and mouth ulceration (1%).
Interstitial Lung Disease
Cases of interstitial lung disease (ILD) have been observed in patients receiving IRESSA (getfitinib) at an overall incidence of about 1%. Approximately 1/3 of the cases have been fatal. The reported incidence of ILD was about 2% in the Japanese post-marketing experience, about 0.3% in approximately 23,000 patients treated with IRESSA (getfitinib) in a US expanded access program and about 1% in the studies of first-line use in NSCLC (but with similar rates in both treatment and placebo groups). Reports have described the adverse event as interstitial pneumonia, pneumonitis and alveolitis. Patients often present with the acute onset of dyspnea, sometimes associated with cough or low-grade fever, often becoming severe within a short time and requiring hospitalization. ILD has occurred in patients who have received prior radiation therapy (31% of reported cases), prior chemotherapy (57% of reported patients), and no previous therapy (12% of reported cases). Patients with concurrent idiopathic pulmonary fibrosis whose condition worsens while receiving IRESSA (getfitinib) have been observed to have an increased mortality compared to those without concurrent idiopathic pulmonary fibrosis.
In the event of acute onset or worsening of pulmonary symptoms (dyspnea, cough, fever), IRESSA (getfitinib) therapy should be interrupted and a prompt investigation of these symptoms should occur. If interstitial lung disease is confirmed, IRESSA (getfitinib) should be discontinued and the patient treated appropriately (see WARNINGS - Pulmonary Toxicity, PRECAUTIONS - INFORMATION FOR PATIENTS and DOSAGE AND ADMINISTRATION - Dosage Adjustment sections).
In patients receiving IRESSA (getfitinib) therapy, there were reports of eye pain and corneal erosion/ulcer, sometimes in association with aberrant eyelash growth (see PRECAUTIONS - INFORMATION FOR PATIENTS section). Hemorrhage, such as epistaxis and hematuria have been reported in patients receiving IRESSA (getfitinib) . There were also rare reports of pancreatitis and very rare reports of corneal membrane sloughing, ocular ischemia/hemorrhage, toxic epidermal necrolysis, erythema multiforme, and allergic reactions, including angioedema and urticaria.
International Normalized Ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin while on IRESSA (getfitinib) therapy. Patients taking warfarin should be monitored regularly for changes in prothrombin time or INR (see CLINICAL PHARMACOLOGY - Drug-Drug Interactions and PRECAUTIONS - DRUG INTERACTIONS sections).
Data from non-clinical (in vitro and in vivo) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarization process (eg, QT interval). The clinical relevance of these findings is unknown.
Read the entire FDA prescribing information for Iressa (Getfitinib) »
Additional Iressa Information
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