Overview of the Chinese package insert for avatrombopag/Suxin

1. Common name: Avatrombopag, Avatrombopag

Product name: Doptelet, Su Kexin

Other names: Avatrombopag maleate, Avatrombopag

2. Who can take avatrombopag? Indications?

1. Treatment of thrombocytopenia (ITP) in patients with chronic liver disease (CLD): Avatrombopag /Avatrombopag is suitable for the treatment of thrombocytopenia in adult patients with chronic liver disease who plan to undergo surgery.

2. Treatment of thrombocytopenia (ITP) in patients with chronic immune thrombocytopenia: Avatrombopag is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an inadequate response to previous treatment.

3. What are the side effects of avatrombopag?

In clinical studies of avatrombopag in the treatment of thrombocytopenia, the most common adverse reactions were fever, abdominal pain, nausea, headache, fatigue and peripheral edema. Hyponatremia was also a rare serious side effect of the drug. Adverse reactions leading to discontinuation include anemia, pyrexia, and myalgia. After avatrombopag was marketed, adverse events including pruritus, rash, choking sensation, erythema, pharyngeal edema, generalized pruritus, macules, facial swelling, and tongue swelling were reported.

4. How should you take avatrombopag?

1. Recommended dosage:

(1)Thrombocytopenia (ITP) in patients with chronic liver disease (CLD): Start avatropopag 10 to 13 days before planned surgery. The recommended daily dose is based on the patient's platelet count before the scheduled procedure. Patients should undergo surgery 5 to 8 days after the last dose of avatropopag. Patients need to take it orally once a day for 5 consecutive days with food. For patients with a platelet count of less than 40×10^9/L, the dosage is 60 mg (3 tablets) once a day, and for patients with a platelet count of 40-50×10^9/L, the dosage is 40 mg (2 tablets) once a day. In the event of a missed dose, the patient should take the next dose as soon as he or she remembers. Patients should not take two doses at once to make up for a missed dose, but should take the next dose at the usual time the next day; all 5 days of dosing should be completed.

(2)Thrombocytopenia in patients with chronic immune thrombocytopenia (ITP): Use the lowest dose of avatrombopag as needed to achieve and maintain a platelet count ≥50×10^9/L, thereby reducing the risk of bleeding. Dose adjustments are based on platelet count response. Do not use avatrombopag to normalize platelet counts. The initial dosage regimen is to start with a starting dose of 20 mg (1 tablet), taken once a day with food.

5. How to store avatrombopag?

Avatrombopag is supplied as 20 mg round, biconvex, yellow film-coated tablets in boxes of 10 or 15 tablets. Store at 20°C to 25°C (68°F to 77°F), with excursions allowed within the temperature range of 15°C to 30°C (59°F to 86°F). Keep tablets in their original packaging.

6. How does avatrombopag work?

Avatrombopag is an orally bioavailable small molecule TPO receptor agonist that stimulates the proliferation and differentiation of megakaryocytes in bone marrow progenitor cells, thereby increasing platelet production. Avatrombopagdoes not compete withTPO for binding to TPO receptors and has an additive effect with TPO on platelet production.

7. What will happen if you take too much avatrombopag?

With overdose, platelet counts may increase excessively and lead to thrombosis or thromboembolic complications. Monitor patients and platelet counts closely. Treat thrombotic complications according to standard of care. There is currently no known antidote for overdose. Hemodialysis is not expected to enhance clearance of worms because only about 6% of worms are excreted by the kidneys and are highly bound to plasma proteins.

8. Who cannot use avatrombopag?

To normalize platelet counts, patients with chronic liver disease should not take avatrombopag.

9. Precautions for use by special groups of people:

1. Breastfeeding women: Because avatrombopag may cause serious adverse reactions in breastfed children, lactating women taking avatrombopag for a short period of time, such as before invasive surgery, should interrupt breastfeeding and pump and discard breast milk during treatment and for two weeks after the last dose of the drug to minimize contact with breastfed children. It is recommended that nursing women receiving long-term treatment not breastfeed during drug treatment and for at least 2 weeks after the last dose of drug.