Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse drug reactions are discussed in more detail in other sections of the labeling: • Interstitial Lung Disease [ see Warnings and Precautions (5.1) ] • Hepatotoxicity [ see Warnings and Precautions (5.2) ] • Gastrointestinal Perforation [ see Warnings and Precautions (5.3) ] • Severe or Persistent Diarrhea [ see Warnings and Precautions (5.4) ] • Ocular Disorders including Keratitis [ see Warnings and Precautions (5.5) ] • Bullous and Exfoliative Skin Disorders [ see Warning and Precautions (5.6) ] The most commonly reported adverse drug reactions (ADRs), reported in more than 20% of the patients and greater than placebo were skin reactions and diarrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact QILU PHARMA, INC.
at 484-838-0633 / 484-875-3013 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of gefitinib tablets is based on the data from 2462 patients with NSCLC who received gefitinib tablets 250 mg daily monotherapy in three randomized clinical studies (Study 2, Study 3 and Study 4).
Patients with a history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis that required steroid treatment or any evidence of clinically active interstitial lung disease were excluded from these studies.
Controlled Studies: Study 2 was a randomized, multicenter, open-label trial in which 1217 patients were randomized to receive first-line treatment for metastatic NSCLC;
607 patients received gefitinib tablets 250 mg daily and 589 patients received carboplatin/paclitaxel.
The median duration of treatment with gefitinib tablets was 5.9 months.
The study population characteristics were: median age 57 years, age less than 65 years (73%), female (79%), Asian (100%), NSCLC adenocarcinoma histology (100%), never smoker (94%), light ex-smoker (6%), ECOG PS 0 or 1 (90%).
5 WARNINGS AND PRECAUTIONS •Interstitial lung disease (ILD): ILD occurred in patients taking gefitinib tablets.
Withhold gefitinib tablets for worsening of respiratory symptoms.
Discontinue gefitinib tablets if ILD is confirmed.
( 2.4 , 5.1 ) •Hepatotoxicity: Obtain periodic liver function testing.
Withhold gefitinib tablets for Grade 2 or higher for ALT and/or AST elevations.
Like all medications, Gefitinib can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: