Iressa Side Effects

Please note - some side effects for Iressa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Iressa - for the Consumer

Iressa

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Iressa:

Acne; diarrhea; dry skin; loss of appetite; mouth ulcers; nausea; unusual weakness; vision problems; vomiting; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the eyelids, mouth, face, lips, or tongue); cough; dark urine; dizziness; eye irritation or pain; extreme fatigue; fever; persistent diarrhea; stomach pain; swelling of the ankles or feet; yellowing of the skin or eyes.

Iressa Side Effects - for the Professional

Iressa

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 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. 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 monotherapy for treatment of NSCLC. In clinical trials, 2–3% of patients stopped therapy due to an adverse drug reaction (ADR). The onset of these ADRs occurred within the first month of therapy.

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 at an overall incidence of about 1%. Approximately 1/3 of the cases have been fatal.

Based on data from worldwide clinical studies, expanded access/compassionate use and post-marketing use the estimated reporting rate of ILD-type events overall is approximately 0.3% outside of Japan and approximately 3% in Japan. From a phase III double blind clinical trial (1692 patients) comparing Iressa plus best supportive care (BSC) to placebo plus BSC in patients with advanced NSCLC who had received 1 or 2 prior chemotherapy regimens and were refractory or intolerant to their most recent regimen, the incidence of ILD-type events in the overall population was similar, and approximately 1% in both treatment arms. The majority of ILD-type events reported were from patients of Asian ethnicity and the ILD incidence among patients of Asian ethnicity receiving Iressa therapy and placebo was similar, approximately 3% and 4% respectively. One ILD-type event was fatal, and this occurred in a patient receiving placebo.

In a Post-Marketing Surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving Iressa was 5.8%.

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 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 therapy should be interrupted and a prompt investigation of these symptoms should occur. If ILD is confirmed, Iressa should be discontinued and the patient treated appropriately.

In patients receiving Iressa therapy, there were reports of eye pain and corneal erosion/ulcer, sometimes in association with aberrant eyelash growth. There have been reports of dry eyes, blepharitis and dry mouth, predominately mild in nature. Hemorrhage, such as epistaxis and hematuria have been reported in patients receiving Iressa. There were also rare reports of pancreatitis and very rare reports of corneal membrane sloughing, ocular ischemia/hemorrhage, toxic epidermal necrolysis, Stevens-Johnson syndrome, 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 therapy. Patients taking warfarin should be monitored regularly for changes in prothrombin time or INR.

Asymptomatic elevations in blood creatinine have been reported.

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.

Side Effects by Body System

Respiratory

Patients with ILD usually present with the acute onset of dyspnea which is sometimes associated with cough or low grade fever. The condition often becomes severe within a short time and requires hospitalization. ILD has been reported in patients who have received prior radiation (31% of reported cases), prior chemotherapy (57% of reported cases), and no previous therapy (12% of reported cases).

Respiratory side effects including interstitial lung disease (ILD) (approximately 1%) has been reported in patients receiving gefitinib. Approximately 1/3 of these cases have been fatal. ILD has been reported at a rate of approximately 2% in Japan in postmarketing experience. ILD has been reported at a rate of about 0.3% in approximately 23,000 patients treated in a US expanded access program and about 1% in the studies of first-line use in non-small cell lung cancer. (but with similar rates in both treatment and placebo groups). Reports have described ILD as interstitial pneumonia, pneumonitis, and alveolitis. Dyspnea (2%) and epistaxis have also been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (up to 67%), nausea (up to 18%), vomiting (up to 12 %) and mouth ulceration (1%) have been reported. Pancreatitis has been reported rarely.

Dermatologic

Dermatologic side effects including rash (up to 54%), acne (up to 33%), dry skin (up to 26%), pruritus (up to 9%), and vesiculobullous rash (1%) have been reported. Toxic epidermal necrolysis and erythema multiforme have been reported very rarely. Three cases of hand-foot syndrome recall have been reported. Two cases of acute generalized exanthematous pustulosis have been reported. A case of terminal hair growth on the nose tip, a case of nonscarring inflammatory alopecia, a case of scarring alopecia, a case of sycosis with pyoderma gangrenosum-like lesions, and a case of pyogenic granuloma-like lesions of the nail have also been reported.

Hand-foot syndrome can occur in patients who have been previously exposed to agents know to cause hand-foot syndrome.

General

General side effects including anorexia (up to 10%), asthenia (up to 6%) and weight loss (up to 5%) have been reported.

Cardiovascular

Cardiovascular side effects including peripheral edema (2%) have been reported.

Ocular

Ocular side effects including amblyopia (2%) and conjunctivitis (1%) have been reported. Eye pain and corneal erosion/ulcer (sometimes associated with aberrant eyelash growth) have also been reported. Corneal membrane sloughing and ocular ischemia/hemorrhage have been reported very rarely.

Hypersensitivity

Hypersensitivity side effects including angioedema and urticaria have been reported very rarely.

Nervous system

There is insufficient data in pediatric patients to establish a causal relationship. Furthermore, there is no evidence to suggest an increased risk of cerebral hemorrhage in adult patients with NSCLC receiving gefitinib.

Nervous system side effects have included cases of CNS hemorrhage and death in pediatric patients with primary central nervous system tumors.

Renal

Renal side effects including hematuria have been reported. A case of nephrotic syndrome has also been reported.

Other

Other side effects including a case of trichomegaly have also been reported.

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