Gilteritinib(Xospata)

Gilteritinib is a prescription drug approved in the United States in November 2018. It targets FMS-like tyrosine kinase 3 (FLT3) and its mutations, including FLT3-ITD and FLT3-TKD such as D835Y and I836. It must be used strictly under medical supervision.

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Drug Testing Report

Drug Approval Certificate

Target of Action

FMS-like tyrosine kinase 3 (FLT3), including FLT3-ITD (internal tandem duplication mutation) and FLT3-TKD (tyrosine kinase domain point mutations, such as D835Y, I836, etc.).

Dosage and Administration

Route and frequency of administration of Gilteritinib: Oral administration, once daily.

The dosage of Gilteritinib should be adjusted according to the patient’s actual condition. For specific circumstances, contact a doctor and strictly follow medical advice.

Recommended Reading: Dosage and Administration of Gilteritinib

Side Effects

Common side effects: Abnormal liver function test results, joint or muscle pain, fatigue.

Serious side effects: Posterior reversible encephalopathy syndrome (PRES), prolonged QTc interval.

Reference Article: Side Effects of Gilteritinib

Use in Special Populations

Pregnancy: Gilteritinib may cause harm to the unborn baby.

Lactation: It is currently unknown whether Gilteritinib is excreted in human milk. Breastfeeding is not recommended during treatment with XOSPATA and for 2 months after the last dose.

Daily Precautions

1. Instruct patients to swallow Gilteritinib tablets whole with a glass of water; do not split, crush, or chew the tablets.

2. If a dose of Gilteritinib is missed by ≤12 hours, the missed dose should be taken as soon as remembered on the same day, and the next dose should be taken at the usual time the following day. If the dose is missed by >12 hours, take the next dose at the regular time without an additional dose to make up for the missed one. Patients should be advised not to take 2 doses within 12 hours.

3. There is a risk of differentiation syndrome. If any symptoms suggestive of differentiation syndrome occur (e.g., fever, cough, dyspnea, rapid weight gain or peripheral edema, hypotension, rash, or decreased urine output), the patient must inform a clinician immediately.

FDA,2022.01