AVATROMBOPAG TAB

Clinical Criteria Summary

Stem cell disorder (i.e., myelodysplastic syndrome)
Patient has not received prior therapy with steroids to increase platelet counts
Thrombocytopenia 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 an appropriate candidate)
Pregnancy and/or breastfeeding

Diagnosis of chronic Immune Thrombocytopenia (ITP)
Platelet count < 30,000 mm³ and/or persistent bleeding resistant/refractory to glucocorticoids
Relapse after second-line therapies (unless contraindicated or patient is not a candidate): Splenectomy, Rituximab

For patients who can become pregnant: Counseling provided on potential risks vs. benefits of taking drug if patient were to become pregnancy
Advise patients not to breastfeed during treatment and for 2 weeks following

Thrombocytopenia due to chronic liver disease (CLD)
Small-molecule thrombopoietin receptor agonist (TPORA) used to prophylactically and temporarily increase platelet counts prior to invasive procedures
Aims to decrease prophylactic platelet transfusion and the need for rescue therapy for bleeding

Thrombocytopenia due to a cause other than CLD (e.g., Immune Thrombocytopenia)
Past or present arterial or venous thrombotic or thromboembolic event(s) or prothrombotic condition(s), including portal, splenic, mesenteric, or systemic thrombosis
Uncontrolled generalized infection
Exposure to eltrombopag or romiplostim in the previous 90 days, or lusutrombopag within the previous 35 days
Planned invasive procedure where routine preprocedural platelet transfusion is not recommended (bone marrow aspiration/biopsy, traction removal of tunneled central venous catheter, paracentesis)
Attempting to normalize platelet counts

Care provided by a VA/VA Community Care hepatologist or locally designated expert in CLD
Pretreatment platelet count less than 50 x 10^9/L (severe thrombocytopenia) within the 2 weeks prior to initiation
CLD (Child-Pugh class C is conditionally not recommended due to limited data and exclusion from clinical trials; no clinically meaningful pharmacokinetic effects observed)
Scheduled to undergo an elective invasive procedure within the next 27 days
Use of platelet transfusions is medically inadvisable (e.g., risk of transfusion reaction, volume overload, platelet refractoriness, acute lung injury) or patient declines blood products
In the previous 6 months: Absence of portal vein thrombosis on computed tomography (CT) or magnetic resonance imaging (MRI) OR presence of hepatopetal portal vein blood flow on doppler ultrasonography