Avatrombopag Maleate

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

Indications : 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.

Dosage & 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

Platelet Count	Once Daily Dose	Duration
Less than 40 X 109/L	60 mg (3 tablets)	5 days
40 to less than 50 109/L	40 mg (2 tablets)	5 days

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.

Platelet Count	Dose Adjustment or Action
Less than 50 after at least 2 weeks of Avatrombopag x 109/L	-Increase One Dose Level per Table 3.Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments
Between 200 and 400 x 109/L	-Decrease One Dose Level per Table 3.Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments.
Greater than 400 x 109/L	-Stop Avatrombopag. Increase platelet monitoring to twice weekly. -When platelet count is less than 150 x109/L, decrease One Dose Level per Table 3 and reinitiate therapy
Less than 50 after 4 weeks of Avatrombopag 40 mg once daily x 109/L	Discontinue Avatrombopag.
Greater than 400 after 2 weeks of Avatrombopag 20 mg weekly x 109/L	Discontinue Avatrombopag.

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

Table 4: Avatrombopag Recommended Starting Dose for Patients with Chronic Immune Thrombocytopenia Based on Concomitant Medications.

Concomitant Medications	Recommended Starting Dose
Moderate or strong dual inhibitors of CYP2C9 and CYP3A4	20 mg (1 tablet) three times a week 40 mg (2 tablets) once daily
Moderate or strong dual inducers of CYP2C9 and CYP3A4

For Detail Please see PDF File.

Or, as directed by the registered physician

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.

Packing : Each box contains 10’s tablets in blister pack.