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Lusutrombopag

Medically reviewed by Drugs.com. Last updated on Jul 27, 2020.

Pronunciation

(loo soo TROM boe pag)

Index Terms

  • S-888711

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Mulpleta: 3 mg

Brand Names: U.S.

  • Mulpleta

Pharmacologic Category

  • Colony Stimulating Factor
  • Hematopoietic Agent
  • Thrombopoietic Agent
  • Thrombopoietin Receptor Agonist

Pharmacology

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.

Distribution

Vd: 39.5 L

Metabolism

Primarily metabolized by CYP4 enzymes, including CYP4A11

Excretion

Feces: 83% (16% as unchanged drug); Urine: ~1%

Onset of Action

The median time to reach the maximum platelet count was 12 days (range: 5 to 35 days)

Time to Peak

6 to 8 hours

Half-Life Elimination

~27 hours

Protein Binding

>99.9%

Special Populations: 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.

Use: Labeled Indications

Chronic liver disease-associated thrombocytopenia: Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

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.

Dosing: Geriatric

Refer to adult dosing.

Administration

Oral: Administer with or without food.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original package.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

1% to 10%: Central nervous system: Headache (5%)

Warnings/Precautions

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.

Monitoring Parameters

Platelet count prior to therapy initiation and not more than 2 days before the scheduled procedure; monitor for signs/symptoms of thromboembolism. Monitor adherence.

Pregnancy Considerations

Adverse events were observed in animal reproduction studies.

Patient Education

What is this drug used for?

• It is used to raise platelet counts before some procedures.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood.

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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