Avatrombopag instructions

1. Common name: Avatrombopag

Product name:Doptelet

All names: Su Kexin, Doptelet, Avatrombopag, Avatrombopag

2. Indications:

1. Treatment of thrombocytopenia in patients with chronic liver disease(CLD):

Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease scheduled for surgery

2. Treatment of thrombocytopenia in patients with chronic immune thrombocytopenia(ITP)：

For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an inadequate response to prior therapy.

3. Usage and dosage:

Patients with chronic liver disease:

Start taking this medicine 10 to 13 days before an elective invasive examination or surgery. Patients should complete 5 days of dosage, and surgery should be started 5 to 8 days after the last dose.

Chronic immune patients:

1.Initial dose is 20 mg once daily , then adjust dose or frequency to maintain platelet count greater than or equal to 50 x109/L, maximum dose is 40mg, Start AvatrombopagAfter treatment, check the platelet count every week until the stable platelet count is greater than or equal to 50 x109/L, then check the platelet count every month. When you stop taking avatrombopag, check your platelet count every week for at least 4 weeks.

2.In the event of a missed dose, the patient should take the missed 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 as per their current regimen.

IV.Dosage form and strength

Tablets: 20 mg, round, biconvex, yellow film-coated tablets, with debossed “AVA” on one side and debossed “20” on the other side.

Five. Contraindications

None

Six.Warnings and 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.

7. Adverse reactions

For chronicITPside effects include headache(31%), fatigue(28%), contusion(26%), nosebleed(19%), upper respiratory tract infection(15 %), joint pain(13%), gum bleeding(13%), petechiae (11%), nasopharyngitis(10%), headache(1.6%), etc.

For patients with chronic liver disease, side effects include abdominal pain(6-7%), nausea(6-7%), fatigue(3-4%), and peripheral edema(2-4%), anemia(0.4%), fever(0.4%), myalgia(0.4%), etc.

8. Drug Interactions

1.The effects of other drugs on patients with chronic immune thrombocytopenia

(1)Concurrent use with moderate or severe CYP2C9 and CYP3A4 dual inhibitors may increase the AUC of avatrombopag , which may increase the risk of toxicity. Reduce the starting dose of DOPTELET when used concomitantly with moderate or severe dual inhibitors of CYP2C9 and CYP3A4. For patients starting on moderate or severe CYP2C9and CYP3A4 dual inhibitors, monitor platelet counts and adjust DOPTELETdose as needed while taking DOPTELET.

(2)Moderate or severe dual inducerssAbout Cypriots2C9andCYP3A4

Coadministration with moderate or strong dual inducers of CYP2C9and CYP3A4 may decrease the AUCof avatropopag which may reduce DOPTELET efficacy. When used concurrently with moderate or strong CYP2C9andCYP3A4 dual inducers, increase the recommended starting dose.For initiation of moderate or strong CYP2C9and pan>CYP3A4Dual inducer patients, while receiving DOPTELET treatment, monitor the platelet count and adjust the DOPTELET dose. as needed.

2.Patients with chronic liver disease

No dose adjustment is required in patients with chronic liver disease.

Nine. Used by specific groups of people

1.Pregnancy

Based on findings from animal reproduction studies, avatrombopag may cause fetal harm when administered to pregnant women. Existing data in pregnant women are insufficient to address the drug-related risk of adverse developmental outcomes. In animal reproduction studies, avatrombopag 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 exposure-based AUCs that were significantly higher than those observed in patients at the maximum recommended dose of 60 mg once daily. Inform pregnant women of potential risks to the fetus.

2.Breastfeeding

There is no information available regardingavatropopag's presence in breast milk, effects on the breastfed infant, or effects on milk production. Avatrombopagis 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.

Lactating women taking DOPTELET in the short term (e.g. before an invasive procedure) should interrupt breastfeeding during treatment and for two weeks after the last dose of DOPTELET and pump and discard breast milk to minimize contact with breastfed children. It is recommended that nursing women receiving long-term DOPTELET treatment should not breastfeed during treatment and for at least 2 weeks after the last dose.

3.Pediatric use

Safety and effectiveness in pediatric patients have not been established.

4.Medication for the Elderly

Clinical studies of DOPTELET did not include a sufficient number of subjects aged 65 years and older to determine whether they responded differently than younger subjects. Other reported clinical experience has found no difference in response between older and younger patients.

10. Clinical Pharmacology

1.Mechanism of action

Avatrombopagis an orally bioavailable small moleculeTPO receptor agonist that stimulates megakaryocyte proliferation and differentiation of bone marrow progenitor cells, leading to increased platelet production. Avatrombopagdoes not compete with TPO for binding to TPO receptors, and has an additive effect on platelet production with TPO.

2.Ingredients

Active ingredient: Avatrombopag

Inactive Ingredients:Lactose monohydrate, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Tablet coating film:Polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, iron oxide yellow.

Laos and Bangladesh have generic drugs that are officially on the market. The specifications are 28 tablets. Each box is about 6100 to 9100. If you want to get more high-quality information, you can contact Yaode, and Yaode will do its best to help you learn more about high-quality overseas drugs.

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