Lusutrombopag's instruction manual and listing status

1. Common names: Lusutrombopag,Lusutrombopag

Product name:MULPLETA, MULPLETA

Full name: Luqu Popa

2. Indications:

Lusutrombopag is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease scheduled for surgery.

3. Usage and dosage:

1. Recommended dosage

Start taking Rutrombopag 8-14 days before planned surgery Patients should receive treatment 2-8 days after the last dose. The recommended dose of Rutrombopag is 3 mg orally once daily for 7 days, with or without food. In the event of a missed dose of Rutrombopag, patients should take the missed dose as soon as possible that day and resume their normal schedule the next day.

Rutrombopag has been studied only in clinical trials in patients with chronic liver disease as a single7-day once-daily dosing regimen. Rutrombopag should not be used in patients with chronic liver disease to normalize platelet counts.

2. Monitoring: Obtain the platelet count before starting treatment with Rutrombopag and no more than 2 days before surgery.

4. Adverse reactions:

In clinical studies of rutrombopag, more common adverse reactions included headache, nausea, portal vein thrombosis (a blockage of the blood vessels that carry blood from the intestines to the liver), and rash.

5. Supply and storage:

Rutrombopag is supplied asrutrombopag 3 mg tablets in child-resistant blister packs containing 7 tablets. Store Rutrombopag Tablets in the original packaging at 20°C to 25°C (68°F to 77°F); tolerance is 15°C to 30°C (59°F to 86°F).

6. Special groups:

1. Breastfeeding women: There is no information on whether Rutrombopag is contained in breast milk, its effects on breastfed infants, and its effects on milk production. The milk of lactating rats contains Rutrombopag. Because of the potential for serious adverse reactions in breastfed children, breastfeeding is not recommended during treatment with Rutrombopag and for at least 28 days after the last dose.

7. Mechanism of action:

Rutrombopag is an orally bioavailable small moleculeTPO receptor agonist that interacts with the transmembrane region of the human TPO receptor expressed on megakaryocytes to induce proliferation and differentiation of megakaryocyte progenitors derived from hematopoietic stem cells and megakaryocyte maturation.

8. Listing situation:

In September 2015, Rutrombopag received the first global approval in Japan for reducing the need for platelet transfusions in adults with chronic liver disease and thrombocytopenia undergoing invasive medical procedures. Rutrombopag was approved by the U.S. Food and Drug Administration (FDA) in July 2018, with the market name Mulpleta; in February 2019, it was approved by the European Medicines Agency (EMA), with the trade name Mulpleo; in June 2023, it was approved by the National Medical Products Administration, and its market name is Vencoda.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f9fd0cfd-717d-4a87-99bc-de7b38807e55