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Treatment of Thrombocytopenia in Patients with Chronic Liver Disease (CLD): It is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Treatment of Thrombocytopenia in Patients with Chronic Immune Thrombocytopenia (ITP): It is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment
Avatrombopag is an orally bioavailable, small molecule TPO receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets. The median time to maximal concentration (Tmax) occurred at 5 to 6 hours post-dose. Avatrombopag has an estimated mean volume of distribution (%CV) of 180 L (25%). Avatrombopag is greater than 96% bound to human plasma proteins. The mean plasma elimination half-life (%CV) of avatrombopag is approximately 19 hours (19%). The mean (%CV) of the clearance of avatrombopag is estimated to be 6.9 L/hr (29%). Avatrombopag is primarily metabolized by cytochrome P450 CYP2C9 and CYP3A4. Fecal excretion accounted for 88% of the administered dose, with 34% of the dose excreted as unchanged avatrombopag. Only 6% of the administered dose was found in urine
Recommended Dose and Duration in Patients with Chronic Liver Disease Scheduled to Undergo a Procedure.
Platelet Count: Less than 40 X 109/L, 60 mg (3 tablets), 5 days
Platelet Count: 40 to less than 50 109/L, 40 mg (2 tablets), 5 days.
Avatrombopag Dose Levels for Titration in Patients with Chronic Immune Thrombocytopenia
40 mg Once Daily, Dose Level: 6
40 mg Three Times a Week AND 20 mg on the Four Remaining Days of Each Week, Dose Level: 5
20 mg Once Daily,Dose Level: 4
20 mg Three Times a Week, Dose Level: 3
20 mg Twice a Week OR 40 mg Once Weekly,Dose Level: 2
20 mg Once Weekly, Dose Level: 1
Avatrombopag Recommended Starting Dose for Patients with Chronic Immune Thrombocytopenia Based on Concomitant;
Moderate or strong dual inhibitors of CYP2C9 and CYP3A4, Recommended Starting Dose: 20 mg (1 tablet) three times a week 40 mg (2 tablets) once daily
It is contraindicated in patients with hypersensitivity to Avatrombopag or any component of this product.
Precautions: Thrombotic/Thromboembolic Complications : Avatrombopag is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or chronic immune thrombocytopenia. Monitor platelet counts and for thromboembolic events and institute treatment promptly.
In patients with chronic liver disease, the most common adverse reactions were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral. In patients with chronic immune thrombocytopenia, the most common adverse reactions were headache, fatigue, confusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae and nasopharyngitis.
Pregnant women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to inform their prescriber of a known or suspected pregnancy. Nursing Mother: Women should be advised not to breastfeed during treatment with Avatrombopag and for at least 2 weeks after the final dose
In the event of overdose, platelet count may increase excessively and result in thrombotic or thromboembolic complications. Closely monitor the patient and platelet count. Treat thrombotic complications in accordance with standard of care.
No antidote for DOPTELET overdose is known.
Hemodialysis is not expected to enhance the elimination of DOPTELET because DOPTELET is only approximately 6% renally excreted and is highly bound to plasma proteins.
Store below 30o C in a dry place
Each film coated tablet contains Avatrombopag 20mg as Avatrombopag Maleate INN