Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Shionogi B.V., Kingsfordweg 151, 1043GR, Amsterdam, The Netherlands
Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures (see section 5.1).
The recommended dose is 3 mg lusutrombopag once daily for 7 days.
The procedure should be performed from day 9 after the start of lusutrombopag treatment. Platelet count should be measured prior to the procedure.
If a dose is missed it should be taken as soon as possible. A double dose should not be taken to make up for a missed dose.
Mulpleo should not be taken for more than 7 days.
No dosage adjustment is necessary in patients 65 years of age or older (see section 5.2).
No dosage adjustment is necessary in patients with renal impairment (see section 5.2).
Due to limited information available, the safety and efficacy of Mulpleo in patients with severe hepatic impairment (Child-Pugh class C) have not been established (see sections 4.4 and 5.1). No dosage adjustment is expected for these patients. Lusutrombopag therapy should only be initiated in patients with severe hepatic impairment if the expected benefit outweighs the expected risks (see sections 4.4 and 5.2). No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
The safety and efficacy of lusutrombopag in children and adolescents (<18 years of age) have not been established. No data are available.
Mulpleo is for oral use. The film-coated tablet is to be taken once daily with liquid, swallowed whole and should not be chewed, divided, or crushed. It can be taken with or without food.
Overdose may induce an excessive increase of platelet counts, and it may subsequently provoke a medically susceptible state to cause thrombosis and thromboembolism. There is no specific antidote for lusutrombopag overdose. Platelet counts should be measured frequently and the condition of patients should be observed closely. Since the protein-binding rate in serum of lusutrombopag is high, haemodialysis is not thought to be effective.
Shelf life: 3 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
OPA/Aluminium foil/PVC film blister with push through aluminium lidding foil, packed in a cardboard box. Each box contains 7 film-coated tablets.
This medicinal product may pose a risk to the environment (see section 5.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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