Thrombotic/thromboembolic complications Patients with chronic liver disease have a risk of portal vein thrombosis and mesenteric vein thrombosis. The risk may be increased due to an invasive procedure. Thromboembolic and thrombotic complications are known to occur with thrombopoetin (TPO) receptor agonists based upon mechanism of action associated with increases in platelets.
Caution should be exercised with respect to thromboembolic events after invasive procedures as well as post-treatment regardless of platelet counts. In patients with thrombosis or thromboembolism, with a history of thrombosis or thromboembolism, with absence of hepatopetal blood flow in the main trunk of the portal vein, or patients with congenital coagulopathy the risk for thrombosis or thromboembolism may increase.
These patients should be clinically monitored when treated with lusutrombopag. 1). 2). Due to the unstable nature of these patients, they should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.
In addition, although no dose adjustment is required in these subjects, platelet count should be measured at least once approximately 5 days after the first dose and as necessary thereafter. Appropriate measures such as discontinuation of lusutrombopag should be taken, if the platelet count reaches ≥50,000/μL as a result of a 20,000/μL increase from baseline.
Use in patients with chronic liver disease undergoing invasive procedures Lusutrombopag should be used when risk for bleeding is considered to be high according to clinical laboratory test values such as platelet counts and of the coagulation-fibrinolysis system, clinical symptoms and type of invasive procedure.
The efficacy and safety of lusutrombopag have not been established when administered before laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs. Retreatment There is limited information on the use of lusutrombopag in patients previously exposed to lusutrombopag.
Use in patients with a history of splenectomy The efficacy and safety of lusutrombopag have not been established when administered in patients with a history of splenectomy. Platelet count should be carefully monitored in patients with a history of splenectomy treated with lusutrombopag.
Co-administration with interferon preparations Interferon preparations have been known to reduce platelet counts, therefore, this should be considered when co-administering lusutrombopag with interferon preparations. Patients with body weight <45 Kg There is limited information on the use of lusutrombopag in patients with body weight <45 Kg.
Platelet count should be measured at least once approximately 5 days after the first dose and as necessary thereafter. Appropriate measures such as discontinuation of lusutrombopag should be taken, if the platelet count reaches ≥50,000/μL as a result of a 20,000/μL increase from baseline.