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Avapag (Avatrombopag INN 20 mg)
Therapeutic Class: Thrombopoietin (TPO) Receptor Agonist
Pack Size: Each HDPE container contains 28 film coated tablets, a silica gel desiccant and polyester coil with a child-resistant closure.

INDICATIONS
• Avatrombopag is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

 

• Avatrombopag 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 AND ADMINISTRATION
Recommended Dosage for patients with Chronic Liver Disease

• Begin Avatrombopag dosing 10-13 days prior to the scheduled procedure. Patients should undergo their procedure 5 to 8 days after the last dose of Avatrombopag.

 

• Avatrombopag should be taken orally once daily for 5 consecutive days with food.

 

• The recommended daily dose of Avatrombopag is based on the patient’s platelet count prior to the scheduled procedure (Refer to Table 1).

 

• In the case of a missed dose, patients should take the next dose of Avatrombopag as soon as they remember. Patients should not take two doses at one time to make up for a missed dose and should take the next dose at the usual time the next day; all five days of dosing should be completed.

 

Table 1: Recommended Dose and Duration

Platelet Count (x109/L)Once Daily DoseDuration
Less than 4060 mg (3 tablets)5 days
40 to less than 5040 mg (2 tablets)5 days

 

Recommended Dosage for Patients with Chronic Immune Thrombocytopenia

• Use the lowest dose of Avatrombopag needed to achieve and maintain a platelet count greater than or equal to 50 x109 /L as necessary to reduce the risk for bleeding.

 

• Dose adjustments are based on platelet count response.

 

• Do not use Avatrombopag to normalize platelet counts.

 

Initial Dose Regimen:
Begin Avatrombopag at a starting dose of 20 mg (1 tablet) once daily with food.

 

Discontinuation: 
Discontinue Avatrombopag if the platelet count does not increase to greater than or equal to 50 x109 /L after 4 weeks of dosing at the maximum dose of 40 mg once daily. Discontinue Avatrombopag if the platelet count is greater than 400 x109 /L after 2 weeks of dosing at 20 mg once weekly.