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.