Cobimetinib Fumarate and Silenor

• Generic Name: cobimetinib
• Dosage Forms: n.a.
• Other Brand Names: Cotellic

In combination with vemurafenib for treatment of unresectable or metastatic melanoma with b-Raf serine-threonine kinase (BRAF) V600E or V600K mutation (designated an orphan drug by FDA for this use).

FDA-approved in vitro diagnostic test (e.g., cobas 4800 BRAF V600 mutation test) required to confirm presence of BRAF V600E or V600K mutation prior to initiation of therapy.

Limited data suggest greater efficacy (longer progression-free and overall survival, higher objective response rates) in patients with BRAF inhibitor-naive disease versus those with disease progression during prior BRAF inhibitor therapy.

• Generic Name: doxepin
• Dosage Forms: tablet
• Other Brand Names: Silenor, Sinequan, Sinequan

Silenor (doxepin) belongs to a group of drugs called hypnotics.

Silenor is used to treat insomnia in people who have trouble staying asleep.

This medication guide provides information about the Silenor brand of doxepin. Sinequan and other generic brands of doxepin used to treat depression or anxiety are not covered in this medication guide.