Rx Item-Doptelet 20Mg Tab 10 By Akarx

for: Thrombocytopenia, Idiopathic (Immune) Thrombocytopenic Purpura Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of: Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. These highlights do not include all the information needed to use DOPTELET safely and effectively. See full prescribing information for DOPTELET . DOPTELET � ( avatrombopag ) tablets , for oral use Initial U.S. Approval: 2018 INDICATIONS AND USAGE DOPTELET (avatrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. (1) DOSAGE AND ADMINISTRATION Begin dosing DOPTELET 10 to 13 days prior to a scheduled procedure. (2.1) Patients should undergo their procedure within 5 to 8 days after the last dose. (2.1) DOPTELET should be taken orally with food once daily for 5 consecutive days. (2.1) The recommended dose of DOPTELET is based on a patient's platelet count prior to a scheduled procedure. (2.1) Recommended Dose and Duration: (2.1) Platelet Count (x109/L) Once Daily Dose Duration Less than 40 60 mg (3 tablets) 5 days 40 to less than 50 40 mg (2 tablets) 5 days DOSAGE FORMS AND STRENGTHS Tablet: 20 mg (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS 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. Monitor platelet counts and for thromboembolic events and institute treatment promptly. (5.1) ADVERSE REACTIONS Most common adverse reactions (? 3%) are: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dova Pharmaceuticals at 1-844-506-3682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal studies, may cause fetal harm (8.1) Lactation: Breastfeeding not recommended during treatment (8.2) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 5/2018

RX ITEM-Doptelet 20Mg Tab 10
Item No.:RX71369-0020-10 NDC No.RX71369002010 7136902010 71369-020-10 71369-0020-10 UPC No.:371369020108 Item No.:RX71369-0020-10 DOPTELET 20MG TAB 10 371369020108 3-71369-02010-8 3-71369-02010-8

Leadiant Biosciences, Inc.
BRAND: DOPTELET NDC: RX71369-0020-10 ,RX71369002010 UPC: 371369-020108,371369020108 DOPTELET 20MG TAB 10 371369020108

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