Safety Profile Similar to Placebo

The most common adverse reaction with Mulpleta vs placebo was headache

Adverse reactions occurring in ≥3% of patients

Adverse Reaction* Mulpleta 3 mg
(N=171)
Placebo
(N=170)
Headache 5% 4%

*Includes treatment-emergent adverse reactions occurring at a rate higher than placebo.

  • Portal vein thrombosis (PVT) was observed in the same proportion of patients treated with Mulpleta (1%) as in patients who received placebo (1%)
    • The thromboses were not associated with a marked increase in platelet count
  • 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
    • Consider the potential increased thrombotic risk when administering Mulpleta to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency, or Protein C or S deficiency)
    • Monitor platelet counts and for thromboembolic events and institute treatment promptly

No known drug-drug interactions with Mulpleta

Dosing

Mulpleta is one 3-mg tablet
taken once daily for 7 days.