Isovue-250 and Trametinib Dimethyl Sulfoxide

• Generic Name: iopamidol
• Dosage Forms: injection, solution
• Other Brand Names: Isovue-200, Isovue-250, Isovue-300, Isovue-370, Isovue-M-200, Isovue-M-300, Isovue-128, Iopamidol-370

Isovue-250 is a radiopaque (RAY dee oh payk) contrast agent. This medicine contains iodine, a substance that absorbs x-rays. Radiopaque contrast agents are used to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Isovue-250 is used to help diagnose certain disorders of the heart, brain, blood vessels, and nervous system.

Isovue-250 may also be used for purposes not listed in this medication guide.

• Generic Name: trametinib
• Dosage Forms: n.a.
• Other Brand Names: Mekinist

In combination with dabrafenib as adjuvant therapy following complete resection of melanoma with BRAF V600E or V600K mutation and nodal involvement.

Alone or in combination with dabrafenib for treatment of unresectable or metastatic melanoma in selected patients with BRAF V600E or V600K mutation (designated an orphan drug by FDA as monotherapy or when used in combination for this use).

FDA-approved in vitro diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E or V600K mutation prior to initiation of monotherapy or combination therapy.

Not recommended for use in patients with melanoma who have experienced disease progression following treatment with a BRAF inhibitor.

Used in combination with dabrafenib for treatment of metastatic non-small cell lung cancer (NSCLC) in patients with BRAF V600E mutation (designated an orphan drug by FDA when used in combination for this use).

FDA-approved diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E mutation prior to initiation of therapy.

Used in combination with dabrafenib for treatment of locally advanced or metastatic anaplastic thyroid cancer in patients with BRAF V600E mutation when no satisfactory locoregional treatment options are available (designated an orphan drug by FDA when used in combination for this use).

FDA-approved diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E mutation prior to initiation of therapy.