Lucius LuciGil Gilteritinib 40mg

Product Information

• Product name: LuciGil Gilteritinib 40mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Gilteritinib
• Current strength: 40mg
• SKU: LU-ITEM-123
• Site category: FLT3 target, other cancer

Product Summary

LuciGil Gilteritinib 40mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Gilteritinib is the active ingredient used for this product page. Public prescribing information for Gilteritinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Gilteritinib is a small molecule that inhibits multiple receptor tyrosine kinases, including FMS-like tyrosine kinase 3 (FLT3). Gilteritinib demonstrated the ability to inhibit FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, tyrosine kinase domain mutations (TKD) FLT3-D835Y and FLT3-ITD-D835Y, and it induced apoptosis in leukemic cells expressing FLT3-ITD.

Reference Indications

Gilteritinib is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Reference Dosage and Administration

The public label should be checked for the indication-specific recommended dosage. Available administration instructions note that the medicine may be taken with or without food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: DIFFERENTIATION SYNDROME Patients treated with Gilteritinib have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution . WARNING: DIFFERENTIATION SYNDROME See for complete boxed warning. Patients treated with Gilteritinib have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

Common Adverse Reactions and Monitoring

The safety profile of Gilteritinib is based on 319 patients with relapsed or refractory AML treated with gilteritinib 120 mg daily in three clinical trials. The median duration of exposure to Gilteritinib was 3.6 months (range 0.1 to 43.4 months). These included cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. Twenty patients (6%) required a dose reduction due to an adverse reaction. Twenty-two (7%) discontinued Gilteritinib treatment permanently due to an adverse reaction.

Drug Interactions and Special Populations

Combined P-gp and Strong CYP3A Inducers: Avoid concomitant use. Strong CYP3A Inhibitors: Consider alternative therapies. ( 2.3 , 7.1 ) P-gp, BCRP, OCT1 Substrates: Decrease the dose of the substrates when coadministered with gilteritinib and as clinically indicated. Avoid concomitant use of Gilteritinib with combined P-gp and strong CYP3A inducers. Strong CYP3A Inhibitors Concomitant use of Gilteritinib with a strong CYP3A inhibitor increases gilteritinib exposure . Consider alternative therapies that are not strong CYP3A inhibitors. Interrupt and reduce Gilteritinib dosage in patients with serious or life-threatening toxicity . Avoid concomitant use of these drugs with Gilteritinib unless their use is considered essential for the care of the patient .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Xospata public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.