What are the precautions for Avatrombopag?

Avatrombopag is an orally bioavailable small molecule thrombopoietin receptor agonist developed by Dova Pharmaceuticals for the treatment of thrombocytopenic diseases. In May 2018, avatrombopag received global approval for the first time in the United States for the treatment of adult patients with chronic liver disease who plan to undergo surgery. (CLD) for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP).

Avatrombopag(Avatrombopag)What are the precautions?

1.TPOReceptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or chronic immune thrombocytopenia. In patients with chronic liver disease, thromboembolic events (portal vein thrombosis) occurred in 0.4% (1/274) of patients receiving DOPTELET. In patients with chronic immune thrombocytopenia, thromboembolic events (arterial or venous) occurred in 7% (9/128) of patients receiving DOPTELET. When treating patients with known thromboembolic risk factors(including inherited prothrombotic disorders such as coagulation factorV Leiden, prothrombin20210A, antithrombin deficiency or proteinCor protein< The potential increased risk of thrombosis should be considered when using DOPTELET in patients with span>Sdeficiency). Patients with chronic liver disease or chronic immune thrombocytopenia should not take DOPTELET to restore platelet counts. Monitor platelet count and follow dosing guidelines to achieve target platelet count. Monitor patients receiving DOPTELET for signs and symptoms of thromboembolic events and initiate treatment promptly.

2.Based on animal reproduction studies, avatrombopag may cause fetal harm when given to pregnant women. In animal reproduction studies, avatropopag resulted in adverse developmental outcomes when administered orally during organogenesis in rabbits and during organogenesis and lactation in rats. However, these findings were observed at exposures based on an AUC that was significantly higher than that observed in patients at the maximum recommended dose of 60 mg once daily. Inform pregnant women of the potential risk to the fetus before use.

3.Avatrombopag is present in the milk of lactating rats. When a drug is present in animal milk, the drug may also be present in human milk. Because of the potential for serious adverse reactions in children who are breastfed with DOPTELET, breastfeeding is not recommended during treatment with DOPTELET and for at least 2 weeks after the last dose.

4.Safety and effectiveness in pediatric patients have not been established.

5.If overdose occurs, 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.

6.Other drugs may affect avatrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medicines you currently take and any medicines you start or stop using.

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