Doptelet

Indications and Usage                                                       07/2025

Dosage and Administration     07/2025

Warnings and Precautions                                                 07/2024

DOPTELET 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.
• Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

• Thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

• DOPTELET tablets and DOPTELET SPRINKLE are not substitutable on a mg-to-mg basis.
• DOPTELET SPRINKLE capsules should be opened, and the contents (oral granules) mixed with a soft food or liquid. Administer immediately after mixing. Do not swallow the capsules whole.
• Administer DOPTELET tablets and DOPTELET SPRINKLE with food.
• Chronic Liver Disease
  : Dose DOPTELET tablets based upon platelet count prior to procedure, orally for 5 days beginning 10 days to 13 days before procedure. For platelet count less than 40×10⁹/L, the dose is 60 mg (3 tablets) orally once daily; for platelet count 40 to less than 50×10⁹/L the dose is 40 mg (2 tablets) orally once daily.
• Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or Chronic Immune Thrombocytopenia
  : Initiate DOPTELET tablets at 20 mg (1 tablet) orally once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50×10⁹/L. Do not exceed 40 mg (2 tablets) per day.
• Pediatric Patients 1 Year to Less than 6 Years with Persistent or Chronic Immune Thrombocytopenia
  : Initiate DOPTELET SPRINKLE oral granules at 10 mg (content of 1 capsule) orally once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50×10⁹/L. Do not exceed 20 mg (content of 2 capsules) per day.

DOPTELET Tablets: 20 mg as round, biconvex, yellow, film-coated tablets debossed with “AVA” on one side and “20” on the other side.

DOPTELET SPRINKLE: 10 mg as Size 0 capsules containing white to off-white granules. The capsules have a white opaque body and light blue opaque cap with a black arrow symbol imprinted on the body and cap.

• Pregnancy: May cause fetal harm
• Lactation: Advise not to breastfeed.