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RUXOLITINIB TAB,ORAL

Clinical Criteria Summary

Document 152

Exclusion Criteria

  • Active or uncontrolled infection
  • Unmanageable drug-drug interaction
  • End stage renal disease (CrCl < 15ml/min) not on dialysis
  • Absolute Neutrophil Count (ANC) < 1000/mm3 and/or platelet count < 50,000/mm3 unless due to marrow involvement or associated with Duffy-null Associated Neutrophil Count (DANC)
  • Lactating

Inclusion Criteria (Provider, Monitoring, & Performance Status)

  • Care provided by a VA or VA Community Care hematology provider
  • Goals of care and role of Palliative Care consult have been discussed and documented
  • Eastern Cooperative Oncology Group performance status 0 - 3
  • Baseline Complete Blood Count (CBC) and documentation of spleen length or volume (by palpation OR imaging)
  • Repeat CBC 1 week after initiation of treatment, then every 2-4 weeks until dose stabilizes, then as clinically necessary

Indication/Diagnosis Requirements

  • Diagnosis of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, post-essential thrombocythemia MF
  • Diagnosis of polycythemia vera with an inadequate response or intolerance to hydroxyurea

Special Population Considerations

  • For females who are breastfeeding: Manufacturer recommends discontinuing breastfeeding during treatment with ruxolitinib and for 2 weeks after stopping treatment.

Document 710

Indication/Context

  • Graft Versus Host Disease (GVHD)

Exclusion Criteria

  • Active or uncontrolled infection
  • Unmanageable drug-drug interaction
  • End-Stage Renal Disease (CrCl < 15ml/min) not on dialysis
  • Absolute Neutrophil Count (ANC)
  • Lactating

Inclusion Criteria

  • Care provided by a VA or VA Community Care hematology provider
  • Eastern Cooperative Oncology Group performance status 0-2
  • Steroid-refractory (or dependent) acute Graft Versus Host Disease (GVHD) following allogeneic stem cell transplant
  • Steroid-refractory chronic GVHD after >/= 1 line of therapy with progression, lack of response or steroid-intolerance

Additional Clinical Requirements

  • For females who are breastfeeding: Manufacturer recommends discontinuing breastfeeding during treatment with ruxolitinib and for 2 weeks after stopping treatment.

Source Documents