Actonel with Calcium and Afatinib Dimaleate

• Generic Name: calcium carbonate / risedronate
• Dosage Forms: tablets
• Other Brand Names: Actonel with Calcium, Actonel and Calcium

Actonel with Calcium (risedronate and calcium) is packaged as two separate medicines: 4 Actonel tablets and 24 calcium tablets. Risedronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractise.

Calcium is a mineral that is needed for many functions of the body, especially bone formation and maintenance.

Actonel is used to treat or prevent postmenopausal and steroid-induced osteoporosis. Actonel is also used to treat Paget's disease of bone.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Actonel with Calcium 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.