Mulpleta (lusutrombopag)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved August 2018

Specific Treatments:

thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure

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General Information

Mulpleta (lusutrombopag) is a small molecule thrombopoietin (TPO) receptor agonist.

Mulpleta is specifically indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

Mulpleta is supplied as a tablet for oral administration. The recommended dose is one 3-mg tablet taken once daily with or without food for 7 days. Begin Mulpleta dosing 8 to 14 days prior to the scheduled procedure. Patients should undergo their procedure 2 to 8 days after their last dose of Mulpleta. A platelet count prior to initiation of Mulpleta therapy should be taken and should not be more than 2 days before the procedure. Mulpleta should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

Clinical Results

FDA Approval

The FDA approval of Mulpleta was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1, L-PLUS 2).

L-PLUS 1:

A total of 97 patients with CLD—as defined by platelet counts <50,000 mcL—who were to undergo invasive procedure were randomized to receive 3 mg lusutrombopag or placebo. The primary endpoint of this trial was the proportion of patients who required no platelet transfusion prior to the primary invasive procedure. A significantly greater proportion of patients treated with Mulpleta did not require platelet transfusion versus placebo (78% versus 13%, respectively).

L-PLUS 2:

A total of 215 patients were randomized 1:1 to receive 3mg of lusutrombopag or placebo for up to seven days. Therapy was initiated on Day 1 and invasive procedures were performed between day nine and day 14. A pre-procedure platelet transfusion was mandated by the study protocol if a patient’s platelet count prior to the invasive procedure had not reached 50,000/µL. Lusutrombopag met the primary endpoint, which was defined as the proportion of patients who required no platelet transfusion prior to the procedure and no rescue therapy for bleeding through seven days following the procedure (64.8% of lusutrombopag patients versus 29% of placebo patients).

Side Effects

The most common adverse effect associated with the use of Mulpleta is headache.

Mechanism of Action

Mulpleta (lusutrombopag) is a small molecule thrombopoietin (TPO) receptor agonist. 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.

Additional Information

For additional information regarding Mulpleta or thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure, please visit https://mulpleta.com/