AXITINIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Major surgery in the previous 4 weeks
- Active (unstable) CNS metastasis (stable brain metastases not requiring steroids is allowed)
- Uncontrolled hypertension
- Current serious wound that is not healing
- Clinically significant gastrointestinal disorder (e.g., active GI bleeding, intraluminal metastatic disease with suspected bleeding, inflammatory bowel disease, ulcerative colitis, other GI conditions associated with an increased risk of perforation)
- Uncontrolled active infection
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
- Caution with use in untreated deep vein thrombosis or pulmonary embolism
Inclusion Criteria
- Care provided by a VA/VA purchased care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Goals of care and role of Palliative Care consult have been discussed and documented
- Female patients of child-bearing potential: counseling provided on contraception and risks vs. benefits of treatment
- Males with female partners of child-bearing potential: use effective contraception during therapy and for 1 week after the last dose
Indications & Regimens (Additional Inclusion Criteria)
- In combination with pembrolizumab for first-line treatment of advanced renal cell carcinoma
- As a single agent for treatment of advanced renal cell carcinoma after failure of 1 prior systemic therapy
Monitoring & Safety Cautions
- Avoid concomitant CYP3A/4 inhibitors (including grapefruit juice); if unavoidable, reduce axitinib dose. Avoid strong CYP3A/4 inducers.
- At baseline, assess blood pressure and dipstick urine for protein; monitor both periodically during therapy.