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Gilteritinib is an oral small molecule tyrosine kinase inhibitor that exerts anti-tumor effects by selectively inhibiting the activity of FMS-like tyrosine kinase 3 (FLT3). Its mechanism of action includes blocking FLT3 receptor signaling, inhibiting leukemia cell proliferation and inducing apoptosis.
1. Generic name: Gilteritinib (Gilteritinib)
2. Trade name: X OSPATA®
It is used to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) confirmed by FDA-approved testing to have FLT3 mutations.
Specifications: 40mg/tablet
Characteristics: Round film-coated tablets.
1. Active ingredient: Giritinib fumarate (equivalent to 40mg giritinib free base)
2. Excipients: Mannitol, hydroxypropylcellulose, magnesium stearate, etc.
1. Recommended dosage: Take 120mg orally once a day, with food or on an empty stomach.
2. Medication requirements: Swallow the tablet whole and do not break, crush or chew it. If you miss a dose, you should take it as soon as possible on the same day, and there should be at least 12 hours between the next dose.
The dose of needs to be adjusted according to toxic reactions:
1. QT interval prolongation : Suspend administration when QTcF>500ms, and reduce to 80mg after recovery.
2. Pancreatitis : Suspend the administration and reduce to 80 mg after symptoms subside.
3. Other with grade ≥3 toxicity: Suspend administration until recovery to grade ≤1 and then reduce to 80 mg.
1. Effect of diet : High-fat diet may delay drug absorption, but does not significantly affect drug efficacy.
2. Vomiting treatment : If you vomit after taking the medicine, there is no need to take a supplementary dose. Take the next dose as originally planned.
3. Monitoring requirements : Blood routine, electrolytes, electrocardiogram, etc. need to be tested regularly before and during treatment.
1. Pregnant women : Contraindicated, may cause fetal damage, effective contraceptive measures must be taken.
2. Lactation : Breastfeeding is prohibited during treatment and within 2 months after stopping the drug.
3. U200c for the elderly: No dose adjustment is required, but adverse reactions need to be closely monitored.
Common (≥20%) include: Myalgia/arthralgia (42%), elevated transaminases (41%), fatigue (40%), fever (35%), diarrhea (34%), dyspnea (34%), rash (30%), pneumonia (30%), etc.
It is contraindicated in those allergic to giritinib or excipients; allergic reactions have been reported in clinical trials.
1. Strong CYP3A inducer (such as rifampicin): Avoid combined use, which may reduce drug efficacy.
2. Strong CYP3A inhibitor (such as itraconazole): Adverse reactions need to be closely monitored for combined use.
3. 5HT2B/σ receptor-targeting drug (such as fluoxetine): may weaken the efficacy of the latter, so avoid combined use.
1. Store at 20°C-25°C (short-term storage at 15°C-30°C is allowed).
2. Keep the original packaging, avoid light and moisture, and keep it out of the reach of children.