DOPTELET Avatrombopag Application Scope

Treatment of thrombocytopenia in adult patients scheduled to undergo an invasive procedure. And Treatment of thrombocytopenia in adult patients refractory to other therapies (e.g., corticosteroids, immunoglobulins).

DOPTELET Avatrombopag Characteristics

Ingredients: Avatrombopag (as avatrombopag maleate)
Properties: round, biconvex, yellow, film-coated; debossed “AVA”/“20.”
Packaging Specification: 20 mg tablets, supplied in blister packs of 10, 15, or 30 tablets per box
Storage: Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F). Keep in original package
Expiry Date: Per product carton/bottle (follow the printed expiration date)
Executive Standard: U.S. FDA–approved Prescribing Information, Revised: 07/2025.
Approval Number: DOPTELET SPRINKLE (oral granules): NDA 219696 (AkaRx Inc.)
Date of Revision: July 2025
Manufacturer: Sobi, Inc. (NDA holder for Sprinkle: AkaRx Inc., a Sobi company)

Guidelines for the Use of DOPTELET Avatrombopag

Dosage and Administration:
- Adults with CLD scheduled for a procedure (Tablets only)
  - Baseline platelets <40×10⁹/L: 60 mg daily (3 tablets) × 5 days
  - Baseline platelets 40 to <50×10⁹/L: 40 mg daily (2 tablets) × 5 days
    Do not use to normalize platelets; use only the studied single 5-day course.
- Adult ITP & Pediatric ITP (≥6 years)—Tablets
  
  Use the lowest dose to keep platelets ≥50×10⁹/L (not to normalize).
  - Initial dose: 20 mg once daily; adjust based on platelet counts per label (max 40 mg/day).
  - Monitoring: check weekly until stable, then monthly; more often after changes or if >400×10⁹/L.
- Administration: Administer via subcutaneous injection using the single-dose autoinjector.
- Missed Dose: If a dose is missed, administer as soon as possible. Resume monthly dosing from the date of the most recently administered dose.
Adverse Reactions:
- Adults with CLD (≥3%): pyrexia, abdominal pain, nausea, headache, fatigue, peripheral edema.
  
  Adult ITP (≥10%): headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, nasopharyngitis.
  
  Pediatric ITP (≥10%): viral infection, nasopharyngitis, cough, pyrexia, oropharyngeal pain.
- Serious Adverse Reactions:
  - Hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias.
Contraindications:Patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.
Precautions:
- Hypersensitivity Reactions: Monitor patients for signs and symptoms. Discontinue use if reactions occur.
- Platelet Count Monitoring: Monitor platelet counts during treatment.
- Pregnancy and Lactation: Advise patients to inform their healthcare provider if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

DOPTELET Interactions

CYP2C9 & CYP3A4 dual inhibitors/inducers: may alter exposure; dose adjustments recommended (different starting/titration regimens are provided in the label for adult/pediatric ITP). Examples include moderate/strong dual inhibitors and dual inducers—consult the label tables for specific starting doses.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.