DOPTELET SPRINKLE (avatrombopag maleate)

The pharmacokinetics of avatrombopag were determined following administration of DOPTELET tablets, and pharmacokinetic parameters are presented as geometric mean (CV%) unless otherwise specified. Avatrombopag demonstrated dose-proportional pharmacokinetics after single doses from 10 mg (0.5 times the lowest approved dosage) to 80 mg (1.3 times the highest recommended dosage). Healthy subjects administered 40 mg of avatrombopag had a geometric mean (%CV) maximal concentration (C max ) of 166 (84%...

14.1 Patients with Chronic Liver Disease The efficacy of DOPTELET for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure was established in 2 identically-designed multicenter, randomized, double-blind, placebo-controlled trials (ADAPT-1 [ NCT01972529 ] and ADAPT-2 [ NCT01976104 ]). In each trial, patients were assigned to the Low Baseline Platelet Count Cohort (<40×10] and ADAPT-2 [ NCT01976104 ]). In each trial, patients were assigned to the Low Baseline Platelet Count Cohort (<40×10 9 /L) or the High Baseline Platelet Count Cohor...

The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: Thrombotic/Thromboembolic Complications [see Warnings and Precautions ( 5.1 ) ] In adult patients with chronic liver disease, the most common adverse reactions (≥3%) were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral. ( 6.1 ) In adult patients with chronic immune thrombocytopenia, the most common adverse reactions (≥10%) were headache, fatigue, contusion, ...

None. None. ( 4 )

Thrombotic/Thromboembolic Complications: DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or immune thrombocytopenia. Monitor platelet counts. Monitor for signs and symptoms of thromboembolic events and institute treatment promptly. ( 5.1 ) 5.1 Thrombotic/Thromboembolic Complications DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists...

7 DRUG INTERACTIONS Moderate or Strong Dual CYP2C9 and CYP3A4 Inducers or Inhibitors: Dose adjustments are recommended for patients with persistent or chronic immune thrombocytopenia. ( 7.1 ) 7.1 Effect of Other Drugs on DOPTELET in Patients with Persistent or Chronic Immune Thrombocytopenia Moderate or Strong Dual Inhibitors of CYP2C9 and CYP3A4 Concomitant use with a moderate or strong dual inhi...