Bleeding disorders:
Indications for DOPTELET:
Thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure. Thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
Adult:
Chronic liver disease: start treatment 10–13 days prior to a procedure. Should undergo procedure within 5–8 days after last dose. Take with food. Platelet count (<40 x 109/L): 60mg once daily for 5 days; (40–<50 x 109/L): 40mg once daily for 5 days. Chronic immune thrombocytopenia: initially 20mg once daily; adjust dose based on platelet count response (see full labeling); max 40mg/day. Discontinue if platelet count <50 x 109/L after 4 weeks of 40mg/day or >400 x 109/L after 2 weeks of 20mg once weekly. If concomitant moderate or strong CYP2C9/CYP3A4 dual inhibitors: 20mg three times weekly; moderate or strong CYP2C9/CYP3A4 dual inducers: 40mg once daily.
Children:
Not established.
Warnings/Precautions:
Chronic liver disease: obtain platelet count prior to treatment and on day of procedure. Chronic immune thrombocytopenia: after therapy initiation, obtain platelet count weekly until ≥50 x 109/L achieved, and then monthly thereafter; and weekly for at least 4 weeks after discontinuation. Increased thrombotic risk with known risk factors (eg, Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency, Protein C or S deficiency); monitor. Do not use to normalize platelet counts. Pregnancy. Nursing mothers: not recommended (during and for ≥2 weeks after last dose).
Pharmacologic Class:
Thrombopoietin receptor agonist.
Interactions:
See Adults. Potentiated by moderate or strong CYP2C9/CYP3A4 dual inhibitors; reduce or adjust dose and monitor. Antagonized by moderate or strong CYP2C9/CYP3A4 dual inducers; increase or adjust dose and monitor.
Adverse Reactions:
Pyrexia, abdominal pain, nausea, headache, fatigue, peripheral edema, contusion, epistaxis, upper RTI, arthralgia, gingival bleeding, petechiae, nasopharyngitis; thrombotic/thromboembolic complications.
Generic Availability:
NO
How Supplied:
Tabs—10, 15
