Afatinib INN 40 mg
Afatinib INN 40 mg
film coated tablet contains Afatinib 40 mg as Afatinib Dimaleate INN.
Indications: EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: Anib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Limitation of Use: The safety and efficacy of Anib have not been established in patients whose tumors have other EGFR mutations. Previously Treated, Metastatic Squamous NSCLC: Anib is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
Dosage and Administration: 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 Anib is 40 mg orally, once daily until disease progression or no longer tolerated by the patient. Severe Renal Impairment: The recommended dose of Anib in patients with severe renal impairment (estimated glomerular filtration rate [eGFR*] 15 to 29 mL/min /1.73 m²) is 30 mg orally, once daily. Anib 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.
Use in Pregnancy and Lactation: Anib
can cause fetal harm when administered to a pregnant woman. There are no
available data on the use of Anib in pregnant women. Lactation: There
are no data on the presence of Afatinib in human milk or its effects on the
breastfed infant or on milk production. Because of the potential for serious
adverse reactions in nursing infants from Anib, a
lactating woman should be advised not to breastfeed during treatment with Anib and for 2 weeks after the final dose.
Packaging: Each box contains 30 tablets in a blister pack.