Description

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

 

Product Features

Product Name	:	Avalet
Generic Name	:	Avatrombopag
Formulation	:	Tablet
Available Pack Size	:	28’s Pot
Available Strength	:	20 mg
Registrations	:	Export Only

 

Indications

Treatment for Low Platelet Count in Chronic Liver Disease (CLD): This Medicine is intended for adults with CLD who have low platelet counts and are preparing for a surgical procedure.
Therapy for Low Platelet Count in Chronic Immune thrombocytopenia (ITP): Adults with chronic immune thrombocytopenia who did not respond well to a prior treatment can receive this treatment for low platelet counts.

 

Avatrombopag Pharmacokinetics

• Type: Avatrombopag is an orally available small molecule TPO receptor agonist.
• Mechanism of Action: It stimulates the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, leading to increased platelet production.
• Time to Maximal Concentration (Tmax): Typically occurs at 5 to 6 hours post-dose.
• Volume of Distribution: Estimated mean volume of distribution is 180 L with a coefficient of variation (CV) of 25%.
• Plasma Protein Binding: Greater than 96% of avatrombopag is bound to human plasma proteins.
• Elimination Half-Life: Mean plasma elimination half-life is approximately 19 hours with a CV of 19%.
• Clearance: Mean clearance of avatrombopag is estimated to be 6.9 L/hr with a CV of 29%.
• Metabolism: Primarily metabolized by cytochrome P450 enzymes CYP2C9 and CYP3A4.
• Excretion: Fecal excretion accounts for 88% of the administered dose, with 34% of the dose excreted as unchanged avatrombopag. Only 6% of the administered dose is found in urine.

 

Side Effects

Common side effects in patients with chronic liver disease include pyrexia, abdominal pain, nausea, headache, fatigue, and peripheral edema.

In patients with chronic immune thrombocytopenia, common side effects include headache, fatigue, confusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.

 

Use in Pregnancy and Lactation

Regarding the use of Avatrombopag in pregnancy, it’s important to inform pregnant women about the potential risks to the fetus. Women who could become pregnant should let their doctor know if they are pregnant or suspect they might be.

For nursing mothers, it’s recommended that they avoid breastfeeding while undergoing treatment with Avalet and for at least 2 weeks after their 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.