VA CFU Criteria Formulary Advisor Reference
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PEXIDARTINIB CAP,ORAL

Generic Name
PEXIDARTINIB CAP
Brand Names
TURALIO
Drug Class
ANTINEOPLASTIC,OTHER
Formulary Status
N
Copay Tier
2
Last Updated
2023-02-09

Clinical Criteria Summary

Exclusion Criteria

  • Baseline ALT, AST, total bilirubin, or direct bilirubin > ULN (local laboratory reference values)
  • Active liver or biliary tract disease, including increased alkaline phosphatase (ALP)
  • Active or chronic hepatitis B viral infection
  • Active or chronic hepatitis C viral infection
  • Known active or chronic HIV infection
  • Concomitant use of strong CYP3A inducers
  • Concomitant use of proton pump inhibitors
  • Concomitant use of hormonal contraceptives (CYP3A substrate), unless another highly effective nonhormonal contraception is used in combination
  • Concomitant use of other CYP3A substrates when minimal decreases in drug concentration can result in serious therapeutic failures
  • Unwilling or unable to comply with recommended laboratory monitoring
  • Breastfeeding

Inclusion Criteria

  • Care provided by a VA/VA Community Care oncologist or locally designated expert
  • Histologically confirmed, symptomatic, nonmetastatic TGCT, including pigmented villonodular synovitis (PVNS) and giant cell tumor of the tendon sheath (GCT-TS)
  • TGCT is associated with severe morbidity or functional limitations
  • TGCT is not amenable to improvement with surgery, or surgical resection is likely to be associated with potentially worse functional limitation or severe morbidity
  • No improvement after 12 weeks of imatinib, disease progression despite imatinib, or imatinib is medically inadvisable (e.g., contraindication, unmanageable toxicity, etc.)

Dosing, Monitoring, and Program Requirements

  • Prescribed at the FDA-approved dose for TGCT, modified as recommended for moderate or strong CYP3A inhibitors and UGT inhibitors (if unavoidable), and for mild to severe renal impairment (CrCl 15–89 mL/min)
  • Pregnancy excluded in the previous 14 days for women of childbearing potential and men who partner with women of childbearing potential
  • Patient counseled on use of highly effective contraception and risks/benefits of treatment
  • Prescriber must be certified; patient must be enrolled in the TURALIO REMS program
  • Use without a prior trial of imatinib requires case-by-case request following a risk-benefit discussion between the patient and provider

Source Documents

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