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Same active ingredient — pay up to 5% less
These brands contain the same active ingredient (Afatinib Dimaleate). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Afatin is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Patient Selection for EGFR Mutation-Positive Metastatic NSCLC: Patients should be selected for first-line treatment of metastatic NSCLC with GILOTRIF based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor specimens.Recommended Dose: The recommended dose of Afatinib is 40 mg orally, once daily until disease progression or no longer tolerated by the patient.Severe Renal Impairment: The recommended dose of Afatinib in patients with severe renal impairment (estimated glomerular filtration rate 15 to 29 mL/min /1.73 m²) is 30 mg orally, once daily. Afatinib should be taken at least 1 hour before or 2 hours after a meal. A missed dose should not be taken within 12 hours of the next dose. Or, as directed by the registered physicians.Pediatric Use: Safety and effectiveness of Afatinib in pediatric patients have not been established.
Side Effects
Diarrhea Bullous and Exfoliative Skin Disorders Interstitial Lung Disease Hepatic Toxicity Keratitis
Cautions & Contraindications
Warnings & Precautions
Diarrhea: Diarrhea has resulted in dehydration with or without renal impairment across the clinical experience; some cases were fatal. Grade3-4 diarrhea occurred in 697 (16%) of the 4257 patients who received Anib across 44 clinical trials. In Study 1, diarrhea occurred in 96% of patients treated with Anib (n=229), of which 15% were Grade 3 in severity and occurred within the first 6 weeks. Renal impairment as a consequence of diarrhea occurred in 6% of patients treated with Anib, of which 1.3% were Grade 3. For patients who develop prolonged Grade 2 diarrhea lasting more than 48 hours, or greater than or equal to Grade 3 diarrhea, Anib should be withheld until diarrhea resolves to Grade 1 or less, and resume Anib with appropriate dose reduction.Bullous and Exfoliative Skin Disorders: Grade 3 cutaneous reactions characterized by bullous, blistering, and exfoliating lesions, occurred in 0.2% of the 4257 patients who received Anib across clinical trials. In Study 1, the overall incidence of cutaneous reactions consisting of rash, erythema, and acneiform rash was 90%, and the incidence of Grade 3 cutaneous reactions was 16%. In addition, the incidence of Grade 1-3 palmar-plantar erythrodysesthesia syndrome was 7%. Anib should be discontinued in patients who develop life-threatening bullous, blistering, or exfoliating lesions.Interstitial Lung Disease (ILD): Interstitial lung disease or ILD-like adverse reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, or alveolitis allergic) occurred in 1.6% of the 4257 patients who received Anib across clinical trials; of these, 0.4% were fatal. Anib should be withheld during evaluation of patients with suspected ILD, and Anib should be discontinued in patients with confirmed ILD.Hepatic Toxicity: In 4257 patients who received Anib across clinical trials, 9.7% had liver test abnormalities, of which 0.2% were fatal. In Study 1, liver test abnormalities of any grade occurred in 17.5% of the patients treated with Anib, of which 3.5% had Grade 3-4 liver test abnormalities. Periodic liver testing should be obtained in patients during treatment with Anib. Anib should be withheld in patients who develop worsening of liver function. In patients who develop severe hepatic impairment while taking Anib, treatment should be discontinued.Keratitis: Keratitis, characterized as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye occurred in 0.7% of patients treated with Anib among 4257 patients across clinical trials, of which 0.05% of patients experienced Grade 3 keratitis. Keratitis was reported in 2.2% patients in Study 1, with Grade 3 in 0.4%. Anib should be withheld during evaluation of patients with suspected keratitis, and if diagnosis of ulcerative keratitis is confirmed, treatment with Anib should be interrupted or discontinued. If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered. Anib should be used with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration.
Contraindications
It is contraindicated in patients with known hypersensitivity to Afatinib or any other components of this product.