Gefitinib Side Effects

Some side effects of gefitinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to gefitinib: oral tablet

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

• weakness.

Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with gefitinib.

For Healthcare Professionals

Applies to gefitinib: oral tablet

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 (0.1%) 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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