Avalet 20 mg (Avatrombopag)

Avalet 20 mg (Avatrombopag) is used to treat thrombocytopenia. Avatrombopag is also used to treat chronic immune thrombocytopenia when other treatments have failed. It was approved by the Food and Drug Administration on May 21, 2018. In Bangladesh, this medicine is manufactured by Drug International Limited. Originator : Doptelet by AkaRx, Inc.

 

Composition: Each film-coated tablet contains Avatrombopag 20mg as Avatrombopag Maleate INN.

Pharmacology: Avalet 20 mg is an orally bioavailable, small-molecule TPO receptor agonist that stimulates the 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 Avalet 20 mg is approximately 19 hours (19%). The mean (%CV) of the clearance of avatrombopag is estimated to be 6.9 L/hr (29%). Avalet 20 mg 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.

What is Avatrombopag used for?

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. For more information visit

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 previous treatment.

Dosage and administration: Recommended Dosage for Patients with Chronic Liver Disease:

Table 1: Recommended Dose and Duration in Patients with Chronic Liver Disease Scheduled to Undergo a Procedure

 

Recommended Dosage for Patients With Chronic Immune Thrombocytopenia: Initial Dose Regimen: Begin Avatrombopag at a starting dose of 20mg (1tablet) once daily with food.

Table 2: Avatrombopag Dose Adjustments for Patients with Chronic Immune Thrombocytopenia

 

Table 3: Avatrombopag Dose Levels for Titration in Patients with Chronic Immune Thrombocytopenia

 

Contraindications: It is contraindicated in patients with hypersensitivity to Avatrombopag or any component of this product.

Precautions: Thrombotic/Thromboembolic Complications :
Avalet 20 mg 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.

Side effects: 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.

Use in Pregnancy and Lactation: 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.

Use in Child: There is no data available.

Drug interactions: In patients starting moderate or strong dual inhibitors of CYP2C9 and CYP3A4 while receiving Avatrombopag, monitor platelet counts and adjust Avatrombopag dose as necessary.

Overdose: There is no data available.

Storage: Store below 30o C in a dry place.

Packing: Each box contains 28’s tablets in a blister pack