Afaripopa is an oral small molecule thrombopoietin receptor agonist (TPO-RA) that selectively binds to and activates human TPO receptors, stimulating proliferation and differentiation of bone marrow megakaryocytes and promoting platelet production.

1、 Indications

Afaripopa is a thrombopoietin receptor agonist that is suitable for the following situations:

1. Chronic liver disease associated thrombocytopenia: Used for the treatment of thrombocytopenia in adult patients with chronic liver disease who plan to undergo surgical procedures.

2. Adult chronic immune thrombocytopenia (ITP): Used for adult patients with chronic ITP who have insufficient response to previous treatments.

3. Childhood ITP: Used for children aged 1 year and above with persistent or chronic ITP who have insufficient response to previous treatment.

2、 Usage and dosage specifications

1. Patients with chronic liver disease

Dose regimen: Select the dose based on preoperative platelet count. Patients with platelet count<40 × 10 ⁹/L should take 60mg (3 tablets) daily, while those with platelet count between 40-50 × 10 ⁹/L should take 40mg (2 tablets) daily, orally for 5 consecutive days, starting 10-13 days before surgery.

Monitoring requirements: Platelet count should be measured before treatment and on the day of surgery.

2. ITP for adults and children aged ≥ 6 years

Initial dose: 20mg (1 tablet) once daily, taken with meals. Adjust the dosage based on platelet response, with a maximum of 40mg/day.

Dose adjustment: When the platelet count is less than 50 × 10 ⁹/L, increase the dose level by one dose per week (20mg → 40mg), and when it is greater than 200 × 10 ⁹/L, decrease the dose.

ITP for children aged 3.1-6

Dosage form selection: DOPTELETPINKLE oral granules (10mg/granule) are used. The initial dose is 10mg (1 capsule) once daily, with a maximum of 20mg/day.

Special usage: The granules should be sprinkled on soft food (such as apple sauce) or liquid and taken immediately. Do not chew or swallow the whole granule.

4. Drug interaction management

CYP2C9/CYP3A4 dual inhibitors (such as fluconazole): The initial dose should be reduced to 20mg three times a week.

CYP2C9/CYP3A4 dual inducers (such as rifampicin): The initial dose needs to be increased to 40mg once daily.

3、 Side effects and precautions

Common adverse reactions

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%), nosebleeds (26%), joint pain (19%), gum bleeding (15%).

3. Children with ITP: viral infection (20%), nasopharyngitis (20%), cough (17%), fever (17%).

Serious risk warning

1. Thrombotic/Embolic Events: The risk of portal vein thrombosis in patients with chronic liver disease is 0.4%, while the incidence of arterial/venous thrombosis in adult ITP patients is 7%. Platelet count needs to be monitored to avoid excessive elevation.

2. Hepatotoxicity: Regular monitoring of liver function is necessary, especially when combined with CYP inhibitors.

3. Bleeding risk: ITP patients need to closely monitor platelet changes during the early stages of treatment.

Medication for special populations

1. Pregnant women: Animal experiments have shown embryotoxicity, and effective contraception is required during medication.

2. Breastfeeding period: Breastfeeding is prohibited during the treatment period and within 2 weeks of discontinuation of medication.

3. Children: The safety of patients aged ≥ 1 has been confirmed, and the dosage form should be selected according to age.

4、 Clinical efficacy data

1. Chronic liver disease: The ADAPT-1/2 study showed that 66-69% of patients in the 60mg group avoided blood transfusions, while 88% of 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 (control group 0 weeks).

3. Children's ITP: 27.8% of patients achieved sustained platelet response (control group 0%), and 81.5% of patients met the standard at least twice.

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