Note: Do not use lusutrombopag to normalize platelet counts. Begin lusutrombopag 8 to 14 days prior to the scheduled procedure. Patients should undergo procedure 2 to 8 days after the last lusutrombopag dose. Obtain a platelet count prior to therapy administration and not more than 2 days before the procedure.
Chronic liver disease-associated thrombocytopenia: Oral: 3 mg once daily for 7 days
Missed doses: If a dose is missed, administer the dose as soon as possible on the same day. Return to the normal dosing schedule the next day.
CrCl ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, mild to moderate renal impairment had no clinically meaningful effects on lusutrombopag pharmacokinetics.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (data are limited in this patient population).
Hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, hemodialysis is not expected to enhance lusutrombopag elimination.
Mild or moderate hepatic impairment (Child-Pugh class A or B): There are no dosage adjustments provided in the manufacturer's labeling; however, mild to moderate hepatic impairment had no clinically meaningful effects on lusutrombopag pharmacokinetics.
Severe hepatic impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Mulpleta: 3 mg
No
Oral: Administer with or without food.
Chronic liver disease-associated thrombocytopenia: Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Lusutrombopag may be confused with avatrombopag, eltrombopag
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Central nervous system: Headache (5%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Thromboembolism: Thrombotic and thromboembolic complications with thrombopoietin receptor agonist use have occurred in patients with chronic liver disease. Thromboses were not associated with a marked increase in platelet count. Due to the potential for increased thrombotic risks, use with caution in patients with known risk factors for thromboembolism (eg, Factor V Leiden, prothrombin 20210A, antithrombin deficiency or protein C or S deficiency). In clinical trials, treatment-emergent portal vein thrombosis was reported (rare). Lusutrombopag should only be used if the potential benefit justifies the risk in patients with ongoing or prior thrombosis or absence of hepatopetal blood flow. Do not administer to patients with chronic liver disease in an attempt to normalize platelet counts.
Other warnings/precautions:
• Appropriate use: Do not use to normalize platelet counts in patients with chronic liver disease.
Substrate of BCRP/ABCG2
There are no known significant interactions.
Adverse events were observed in animal reproduction studies.
It is not known if lusutrombopag is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for at least 28 days after the last lusutrombopag dose. Lactating females should pump and discard breast milk during lusutrombopag treatment and for at least 28 days after the last lusutrombopag dose.
Platelet count prior to therapy initiation and not more than 2 days before the scheduled procedure; monitor for signs/symptoms of thromboembolism. Monitor adherence.
Lusutrombopag is an orally bioavailable, small molecule thrombopoietin (TPO) receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in an increased platelet production.
Onset: The median time to reach the maximum platelet count was 12 days (range: 5 to 35 days)
Distribution: Vd: 39.5 L
Protein binding: >99.9%
Metabolism: Primarily metabolized by CYP4 enzymes, including CYP4A11
Half-life elimination: ~27 hours
Time to peak: 6 to 8 hours
Excretion: Feces: 83% (16% as unchanged drug); Urine: ~1%
Hepatic function impairment: The mean observed lusutrombopag Cmax and AUC0-τ decreased by 20% to 30% in patients with severe hepatic impairment (Child-Pugh class C) compared to patients with Child-Pugh class A or B liver disease.
Tablets (Mulpleta Oral)
3 mg (per each): $1,457.14
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