Cobimetinib Fumarate and INOmax inhalation gas

• 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: nitric oxide
• Dosage Forms: gas, for inhalation
• Other Brand Names: Inomax

INOmax is a gas that is inhaled. It works by relaxing smooth muscle to widen (dilate) blood vessels, especially in the lungs.

INOmax is used together with a breathing machine (ventilator) to treat respiratory failure in premature babies.

Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

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