Mulpleta Lusutrombopag Tablets

1. Indications and Usage
Thrombocytopenia in Chronic Liver Disease:
Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Goal: To reduce the need for platelet transfusion and the risk of bleeding during the procedure.
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY.
Recommended Dosage:
Dose: 3 mg once daily.
Duration: Administer orally with or without food for a maximum of 7 days.
Timing of Administration:
Initiate treatment 8 to 14 days before the scheduled procedure.
The procedure should be performed between 2 and 8 days after the last dose.
Monitoring:
Monitor platelet counts prior to initiation of dosing and prior to the procedure (no more than 2 days before).
3. Mechanism of Action
TPO Receptor Agonist:
Lusutrombopag is an orally bioavailable small molecule that binds to the transmembrane domain of the human TPO receptor (c-Mpl).
Megakaryocyte Maturation:
It mimics the action of endogenous TPO, stimulating the proliferation and differentiation of megakaryocyte progenitor cells in the bone marrow, leading to increased platelet production.
4. Safety and Warnings
Thrombotic/Thromboembolic Complications:
Treatment may increase the risk of thrombotic/thromboembolic complications. This risk may persist for several weeks after discontinuation.
Monitor for signs of thrombosis (e.g., portal vein thrombosis).
Discontinue Lusutrombopag if platelet count exceeds 400 × 10⁹/L.
Loss of Response:
If there is a loss of response (i.e., platelet count does not increase despite adherence), consider the development of neutralizing antibodies.
5. Adverse Reactions
Most Common (≥3%):
Headache, nausea, diarrhea, and pyrexia.
Serious Reactions:
Portal vein thrombosis (PVT), hepatic encephalopathy.
6. Drug Interactions
CYP Enzymes and Transporters:
Lusutrombopag is a substrate of CYP4 enzymes (e.g., CYP4A11) and BCRP/P-gp transporters.
Avoid concomitant use with strong CYP4A inhibitors or inducers.
Antacids:
No clinically significant interaction observed with cation-containing antacids.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Lusutrombopag.
Excipients: D-Mannitol, Microcrystalline Cellulose, Magnesium Oxide, Sodium Lauryl Sulfate, Hydroxypropyl Cellulose, Calcium Carboxymethylcellulose, Magnesium Stearate.
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).