LUSUTROMBOPAG TAB
Clinical Criteria Summary
Indication & Mechanism
- Small-molecule thrombopoietin receptor agonist (TPORA)
- Used in patients with thrombocytopenia due to chronic liver disease
- Indicated to prophylactically and temporarily increase platelet counts prior to invasive procedures
- Goal is to decrease prophylactic platelet transfusion and the need for rescue therapy for bleeding
Exclusion Criteria
- Past or present arterial or venous thrombotic or thromboembolic event(s) or prothrombotic condition(s), including portal or splenic mesenteric systemic thrombosis
- Thrombocytopenia (< 150 x 109/L) due to a cause other than chronic liver disease
- Uncontrolled generalized infection
- Exposure to eltrombopag or romiplostim in the previous 90 days or avatrombopag within the previous 35 days
- Planned invasive procedure is one for which routine preprocedural platelet transfusion is not recommended (e.g., bone marrow aspiration or biopsy, traction removal of tunneled central venous catheter, paracentesis)
- Attempting to normalize platelet counts with lusutrombopag
Inclusion Criteria
- Care provided by a VA / VA Community Care hepatologist or locally designated expert in chronic liver disease
- Pretreatment platelet count less than 50 x 109/L (i.e., severe thrombocytopenia) in the 2 weeks prior to initiation of lusutrombopag
- Chronic liver disease (Child-Pugh class C is conditionally not recommended)
- Scheduled to undergo an elective invasive procedure within the next 29 days
- Use of platelet transfusions is medically inadvisable (e.g., risk of transfusion reaction, volume overload, platelet refractoriness, acute lung injury), or the patient declines any blood products
- In the previous 6 months: (1) Absence of portal vein thrombosis on computed tomography (CT) or magnetic resonance imaging (MRI) OR (2) Presence of hepatopetal portal vein blood flow on doppler ultrasonography
Special Clinical Considerations
- Child-Pugh class C chronic liver disease is conditionally not recommended due to limited data; Cmax and AUC0–Τ decreased by 20%–30% relative to mild to moderate hepatic impairment
- Hepatopetal refers to normal direction of blood flow towards the liver