Adefovir Dipivoxil and Afatinib Dimaleate

• Generic Name: adefovir
• Dosage Forms: tablet
• Other Brand Names: Hepsera

Adefovir is an antiviral medicine that is used to treat chronic hepatitis B in adults and children at least 12 years old. Adefovir is not a cure for chronic hepatitis B.

Adefovir may also be used for purposes not listed in this medication guide.

• Generic Name: afatinib
• Dosage Forms: n.a.
• Other Brand Names: Gilotrif

First-line treatment of metastatic NSCLC in patients with tumors positive for nonresistant epidermal growth factor receptor (EGFR) mutations (e.g., exon 19 deletions [del19], exon 21 substitution [L858R] mutations) as detected by an FDA-approved diagnostic test (designated an orphan drug by FDA for this use). Nonresistant EGFR mutations are those where efficacy of afatinib may be predicted by a clinically meaningful reduction in tumor size at the recommended dosage of the drug and/or inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation is expected at afatinib concentrations sustainable at the recommended dosage.

Treatment of metastatic squamous NSCLC that has progressed following therapy with platinum-based chemotherapy (designated an orphan drug by FDA for this use).

Safety and efficacy not established in patients with resistant EGFR mutations.