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Avatrombopag is an oral small-molecule thrombopoietin receptor agonist (TPO-RA). It stimulates the proliferation and differentiation of bone marrow megakaryocytes and promotes platelet production by selectively binding to and activating human TPO receptors.
Avatrombopag is a thrombopoietin receptor agonist, suitable for the following conditions:
1. Thrombocytopenia associated with chronic liver disease : For the treatment of thrombocytopenia in adult patients with chronic liver disease who plan to undergo surgery.
2. Chronic immune thrombocytopenia (ITP) in adults: For adult patients with chronic ITP who have had an inadequate response to previous treatment.
3. Pediatric ITP : It is used for pediatric patients 1 year old and above with persistent or chronic ITP who have insufficient response to previous treatment.
Dose regimen : Select the dose based on the preoperative platelet count. For those with platelets <40×10⁹/L, 60 mg (3 tablets) per day, for those with 40-50×10⁹/L, 40 mg (2 tablets) per day, take orally for 5 days, and start administration 10-13 days before surgery.
Monitoring requirements : Platelet count needs to be measured before treatment and on the day of surgery.
Initial dose of : 20 mg (1 tablet) once a day, with food. Adjust the dose according to platelet response, with a maximum of no more than 40 mg/day.
Dose adjustment : When platelets are <50×10⁹/L, the dose level needs to be increased weekly (20mg→40mg), and when platelets are >200×10⁹/L, the dose needs to be reduced.
Dosage form selection : Use DOPTELETSPRINKLE oral granules (10mg/pellet). The initial dose is 10 mg (1 capsule) once a day, and the maximum dose should not exceed 20 mg/day.
Special usage : The granules need to be sprinkled into soft food (such as applesauce) or liquid and taken immediately. Do not chew or swallow the whole tablet.
CYP2C9/CYP3A4 dual inhibitor (such as fluconazole): The initial dose needs to be reduced to 20 mg three times a week.
CYP2C9/CYP3A4 dual inducer (such as rifampin): The initial dose needs to be increased to 40 mg once daily.
1. Patients with chronic liver disease : Fever (10%), abdominal pain (7%), nausea (7%), headache (6%), peripheral edema (3%).
2. Adult ITP patients :Headache (31%), fatigue (28%), nose bleeding (26%), joint pain (19%), and gum bleeding (15%).
3. Children with ITP : Viral infection (20%), nasopharyngitis (20%), cough (17%), fever (17%).
1. Thrombosis/embolic events :The risk of portal vein thrombosis in patients with chronic liver disease is 0.4%, and the incidence of arterial/venous thrombosis in adult ITP patients is 7%. Platelet count needs to be monitored to avoid excessive elevation.
2. Hepatotoxicity : Liver function needs to be monitored regularly, especially when used in combination with CYP inhibitors.
3. Bleeding risk : Patients with ITP need to closely monitor platelet changes in the early stages of treatment.
1. Pregnant women : Animal experiments show embryotoxicity, so effective contraception is required during medication.
2. Lactation : Breastfeeding is prohibited during treatment and within 2 weeks of stopping the drug.
3. Children : The safety of patients ≥ 1 year old has been confirmed, and the dosage form needs to be selected according to age.
1. Chronic liver disease : The ADAPT-1/2 study showed that 66-69% of patients in the 60mg group avoided blood transfusions, and 88% of the patients in the 40mg group met the standard.
2. Adult ITP :After 6 months of treatment, the median effective response time was 12.4 weeks (0 weeks in the control group).
3. Children's ITP : 27.8% of patients achieved sustained platelet response (0% in control group), and 81.5% of patients achieved the target at least twice.