cobimetinib (Cotellic®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of unresectable or metastatic melanoma in patients with a BRAF V600E or V600K mutation (in combination with vemurafenib)

All of the following must be met as a condition for coverage:

  • Treatment of unresectable or metastatic melanoma in patients with a BRAF V600E or V600K mutation (in combination with vemurafenib)

This Medication is Not Approvable for the following condition(s):

  • Any condition not listed above as an approved indication

Dosing:

FDA-approved uses

  • Melanoma, unresectable or metastatic (with BRAF V600E or V600K mutations)
Usual dosage
  • 60 mg once daily days 1 to 21 of each 28-day treatment cycle (in combination with vemurafenib)

Dosage adjustment

  • Recommended cobimetinib dose reductions for toxicity (vemurafenib may also require dosage adjustment):
    • First dose reduction: 40 mg once daily
    • Second dose reduction: 20 mg once daily
    • Subsequent modification (if unable to tolerate 20 mg once daily): Permanently discontinue

Approval:

One year


 

Last review date: July 25, 2016