Gilteritinib Application Scope

Xospata is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a FLT3 mutation, as detected by an FDA-approved test. It is an oral targeted therapy designed to selectively inhibit FLT3, a driver mutation associated with poor prognosis in AML, thereby providing an important treatment option for patients who have limited therapeutic alternatives.

Gilteritinib Characteristics

Ingredients: Active ingredient: Gilteritinib fumarate
Properties: Tyrosine kinase inhibitor targeting FLT3 and AXL
Packaging Specification: 40 mg film-coated tablets, blister packs
Storage: Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F)
Expiry Date: As indicated on the package (typically 24–36 months from manufacture)
Executive Standard: International pharmaceutical quality standard (ICH, GMP compliance)
Approval Number: Refer to local regulatory authority approval code (e.g., FDA, EMA, NMPA)
Date of Revision: As per the latest prescribing information update
Manufacturer: Astellas Pharma Inc.

Guidelines for the Use of Xospata

Dosage and Administration:
- Recommended Dose: 120 mg orally once daily
- Administration: Take at the same time each day, with or without food. Swallow tablets whole.
- Missed Dose: If a dose is missed or vomited, take the next scheduled dose at the regular time. Do not double-dose.
Adverse Reactions:
- Common Adverse Reactions:
  - Fatigue
  - Nausea
  - Diarrhea
  - Constipation
  - Elevated liver enzymes (ALT, AST)
  - Muscle/joint pain
  - Rash
  - Fever
- Serious Adverse Reactions:
  - Differentiation syndrome
  - QT interval prolongation
  - Pancreatitis
  - Posterior reversible encephalopathy syndrome (PRES)
Contraindications: Known hypersensitivity to Gilteritinib or excipients
Precautions:
- Monitor ECG and electrolytes for QT prolongation.
- Assess for differentiation syndrome and initiate corticosteroids promptly if suspected.
- Monitor liver function, pancreatic enzymes, and blood counts.
- Use caution in patients with severe renal or hepatic impairment.

Gilteritinib Interactions

CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): May increase Gilteritinib exposure → risk of toxicity
CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort): May decrease Gilteritinib exposure → reduced efficacy
QT-prolonging drugs (e.g., amiodarone, sotalol, fluoroquinolones): Increased risk of cardiac arrhythmia
P-gp and BCRP substrates: Potential interactions; monitor closely

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.