Avapag 20

• Thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure
• Thrombocytopenia in patients with chronic immune thrombocytopenia who have had insufficient response to previous treatment

Chronic Liver Disease (CLD) - Pre-procedure:

• Platelet count <40 × 10⁹/L: 60 mg (3 tablets) once daily for 5 days with food
• Platelet count 40 to <50 × 10⁹/L: 40 mg (2 tablets) once daily for 5 days with food
• Initiate dosing 10-13 days prior to procedure; perform procedure 5-8 days after last dose

Chronic Immune Thrombocytopenia (ITP):

• Initial dose: 20 mg (1 tablet) once daily with food
• Dose level adjustments (based on platelet count):
  • <50 × 10⁹/L after ≥2 weeks: Increase 1 dose level
  • 200-400 × 10⁹/L: Decrease 1 dose level
  • >400 × 10⁹/L: Stop Avatrombopag; monitor twice weekly

ITP Dose Levels: Level 6: 40 mg/day; Level 5: 40 mg 3x/week + 20 mg remaining 4 days; Level 4: 20 mg/day; Level 3: 20 mg 3x/week; Level 2: 20 mg 2x/week OR 40 mg weekly; Level 1: 20 mg weekly

Chronic Liver Disease (CLD):

• Pyrexia (8-11%)
• Abdominal pain (6-7%)
• Nausea (6-7%)
• Headache (4-7%)
• Fatigue (3-4%)
• Peripheral edema (3-4%)

Chronic ITP:

• Headache, fatigue, confusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, nasopharyngitis

Rare (<1%): Hyponatremia (0.7%)

Serious Precautions:

• TPO receptor agonists are associated with thrombotic and thromboembolic complications
• Portal vein thrombosis reported in patients with chronic liver disease
• Caution in patients with known risk factors for thromboembolism (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency, Protein C or S deficiency)
• Do not use in an attempt to normalize platelet counts
• Monitor for signs and symptoms of thromboembolic events
• May cause fetal harm during pregnancy
• Breastfeeding not recommended during treatment and for 2 weeks after the last dose