Cobimetinib Fumarate and Vituz Oral Solution

• 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: chlorpheniramine / hydrocodone
• Dosage Forms: oral solution
• Other Brand Names: Vituz, TussiCaps, Tussionex PennKinetic, S-T Forte 2, HyTan, Novasus

• The use of hydrocodone in children younger than 6 years has led to deadly breathing problems. Talk with the doctor.
• This medicine is not for use in children younger than 18 years of age. The benefits of taking Vituz (hydrocodone and chlorpheniramine oral solution) for a cough due to allergies, a cold, or other infection do not outweigh the risks in children. If your child has been given Vituz (hydrocodone and chlorpheniramine oral solution) or if you have any questions, talk with your child's doctor.