Cobimetinib Fumarate and Flurazepam Hydrochloride

• 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: flurazepam
• Dosage Forms: n.a.
• Other Brand Names: Dalmane

Short-term management of insomnia. Has been used effectively for periods up to 4 weeks in duration.

Has been used effectively in individuals with difficulty in falling asleep, nocturnal awakenings, and/or early morning awakening.

May exhibit carryover effect (i.e., more effective on second, third, and fourth nights of use than on first night) because of accumulation of active metabolite. Effect may persist on first and sometimes second night after discontinuance.

Because of long half-life, may be more likely to result in residual sedative effects and in impaired psychomotor and mental performance during continued therapy, although partial tolerance to these effects can occur. Differences among hypnotics in residual and cumulative CNS depressant effects may be particularly important in geriatric patients, those with potentially impaired elimination of the drugs, and those whose job or life-style requires unimpaired intellectual or psychomotor function.