ELTROMBOPAG POWDER,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Stem cell disorder (i.e., myelodysplastic syndrome)
- Patient has not received prior therapy, with steroids, to increase platelet counts
- Thrombocytopenia is secondary to bone marrow suppressive anti-cancer therapy, antibiotics or other drugs
- Thromboembolic events within the past year, unless evaluated by a hematology provider and deemed to be an appropriate candidate
- Pregnancy and/or lactating
Inclusion Criteria
- Diagnosis of chronic immune thrombocytopenia (ITP)
- Platelet count less than 30,000 mm3 and/or persistent bleeding resistant / refractory to glucocorticoids
- Patient has relapse after the following second-line therapies (unless contraindicated or patient is not a candidate): Splenectomy and rituximab
Additional Inclusion Criteria
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy