Dabrafenib Mesylate and Ioversol

• Generic Name: dabrafenib
• Dosage Forms: n.a.
• Other Brand Names: Tafinlar

Used in combination with trametinib as adjuvant therapy following complete resection of melanoma with BRAF V600E or V600K mutation and nodal involvement.

Used as a single agent for the treatment of unresectable or metastatic melanoma in patients with BRAF V600E mutation (designated an orphan drug by FDA as monotherapy for this use).

Used in combination with trametinib for treatment of unresectable or metastatic melanoma in patients with BRAF V600E or V600K 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 monotherapy; also required to confirm presence of BRAF V600E or V600K prior to initiation of combination therapy.

Not recommended for use in patients with wild-type BRAF melanoma; safety and efficacy not established. (See Tumor Promotion in Wild-Type BRAF Tumors under Cautions.)

Used in combination with trametinib 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.

Not recommended for use in patients with wild-type BRAF NSCLC; safety and efficacy not established. (See Tumor Promotion in Wild-Type BRAF Tumors under Cautions.)

Used in combination with trametinib 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.

Not recommended for use in patients with wild-type BRAF anaplastic thyroid cancer; safety and efficacy not established. (See Tumor Promotion in Wild-Type BRAF Tumors under Cautions.)

• Generic Name: ioversol
• Dosage Forms: n.a.
• Other Brand Names: Optiray 240, Optiray 300, Optiray 320, Optiray 350, Optiray 160

Ioversol is a radiopaque (RAY dee oh payk) contrast agent. Ioversol contains iodine, a substance that absorbs x-rays. 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.

Ioversol is used to help diagnose certain disorders of the heart, brain, and blood vessels.

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