Remifentanil Hydrochloride and Trametinib Dimethyl Sulfoxide

• Generic Name: remifentanil
• Dosage Forms: n.a.
• Other Brand Names: Ultiva

As the analgesic component in the induction and maintenance of general anesthesia for inpatient and outpatient procedures. Although remifentanil has been used as the primary agent for induction of anesthesia, its use as the sole agent in general anesthesia is not recommended because loss of consciousness cannot be ensured and a high incidence of apnea, muscle rigidity, or tachycardia is possible.

May be continued in the immediate postoperative period in adults for whom later transition to longer-acting analgesics is desired; must be used under direct supervision of an anesthesia clinician in a postoperative anesthesia care unit or intensive care unit (ICU). Long-term (i.e., >16 hours) use of remifentanil in ICU patients has not been established to date.

May be particularly useful in surgical procedures requiring a rapid onset of analgesia and rapid recovery.

As the analgesic component of monitored anesthesia care (e.g., in conjunction with local or regional anesthesia for surgical procedures, including ophthalmic surgery, breast biopsy, and other superficial surgical procedures ) in adults.

• 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.