Lusutrombopag

What is Lusutrombopag?

Lusutrombopag (MULPLETA) is a thrombopoietin receptor agonist used to treat low platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to have a procedure.

What are the uses of this medicine?

• This medicine is used to treat low platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to have a procedure.

How does this medicine work?

• Lusutrombopag is an orally bioavailable, small molecule TPO receptor agonist that interacts with the transmembrane domain of human TPO receptors expressed on megakaryocytes to induce the proliferation and differentiation of megakaryocytic progenitor cells from hematopoietic stem cells and megakaryocyte maturation.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with MULPLETA .

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

• Obtain a platelet count prior to initiation of MULPLETA therapy and not more than 2 days before the procedure.
• Begin MULPLETA dosing 8-14 days prior to a scheduled procedure.
• Patients should undergo their procedure 2-8 days after the last dose.

Recommended Dosage The recommended dosage of MULPLETA is 3 mg taken orally once daily with or without food for 7 days.

Administration

• Take MULPLETA exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you when to start taking MULPLETA.
• Take MULPLETA 1 time each day for 7 days.
• MULPLETA may be taken with or without food.
• If you miss a dose of MULPLETA, take the missed dose as soon as possible on the same day and return to your normal schedule the following day.
• If you take too much MULPLETA, call your healthcare provider or go to the nearest hospital emergency room right away.
• Your healthcare provider will check your platelet count before you start treatment with MULPLETA and before your procedure.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablet: 3 mg

This medicine is available in fallowing brand namesː

• MULPLETA

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache

MULPLETA may cause serious side effects, including:

• Blood clots

What special precautions should I follow?

• MULPLETA is a thrombopoietin (TPO) receptor agonist, and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Monitor platelet counts and for thromboembolic events and institute treatment promptly.

What to do in case of emergency/overdose?

• In the event of overdose, platelet count may increase excessively and result in thrombotic or thromboembolic complications.

Management for overdosage:

• No antidote for MULPLETA overdose is known.
• In the event of overdose, platelet count may increase excessively and result in thrombotic or thromboembolic complications.
• Closely monitor the patient and platelet count. Treat thrombotic complications in accordance with standard of care.
• Hemodialysis is not expected to enhance the elimination of MULPLETA because lusutrombopag is highly bound to protein in plasma.

Can this medicine be used in pregnancy?

• There are no available data on MULPLETA in pregnant women to inform the drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lusutrombopag.
• Inactive ingredients: D-mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropyl cellulose, carboxymethylcellulose calcium, magnesium stearate, hypromellose, triethyl citrate, titanium dioxide, red ferric oxide, and talc.

Who manufactures and distributes this medicine?

• Manufactured for: Shionogi Inc., Florham Park, NJ 07932

What should I know about storage and disposal of this medication?

• Store MULPLETA at room temperature between 68°F and 77°F (20°C to 25°C).
• MULPLETA comes in a child-resistant blister pack.
• Keep MULPLETA in the packaging that it comes in.

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