VEMURAFENIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Uncorrectable electrolyte abnormalities, QTc ≥500msec, or long QT syndrome
- Use of concomitant medications known to prolong QT interval
- Severe baseline hepatic impairment (Child-Pugh Class C) or severe renal impairment (creatinine clearance <30 mL/min)
- Active or symptomatic brain metastases
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Care provided by a VA/VA purchased care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care and role of Palliative Care consult have been discussed and documented
- Female patients of child-bearing potential: counseling provided on contraception during treatment and for 2 weeks after completing treatment and risks vs. benefits of treatment
Indications / Additional Inclusion Criteria (One must be met)
- Unresectable or metastatic melanoma with BRAF V600E mutation
- In combination with cobimetinib for unresectable or metastatic melanoma with BRAF V600E mutation if patient cannot tolerate dabrafenib plus trametinib
- Erdheim-Chester Disease (ECD) with BRAF V600 mutation
Treatment Preferences
- Dabrafenib plus trametinib is the preferred BRAF + MEK inhibitor combination.