The First Global Generic Afatinib

Taking Afanix

Use Afanix as directed by Oncologist.

• • Take Afanix by mouth on an empty stomach at least 1 hour before or 2 hours after eating.

• • Take Afanix on a regular schedule about 24 hours apart, unless your doctor tells you otherwise.

• • Continue to take Afanix even if you feel well. Do not miss any doses.

• • If you miss a dose of Afanix, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

How Afanix works

Afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation of ErbB signaling.

Afatinib demonstrated inhibition of autophosphorylation and in vitro proliferation of cell lines expressing wild-type EGFR or those expressing selected EGFR exon 19 deletion mutations or exon 21 L858R mutations, including some with a secondary T790M mutation, at afatinib concentrations achieved, at least transiently, in patients. In addition, afatinib inhibited in vitro proliferation of cell lines overexpressing HER2.

Treatment with afatinib resulted in inhibition of tumor growth in nude mice implanted with tumors either overexpressing wild type EGFR or HER2 or in an EGFR L858R/T790M double mutant model.