Gilternib (Gilteritinib INN) 40 mg

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Gilternib, also referred to by its International Nonproprietary Name (INN) Gilteritinib, is prescribed at a 40 mg dosage for adults dealing with relapsed or refractory acute myeloid leukemia (AML) characterized by a FLT3 mutation. Acting as a potent and specific inhibitor of FLT3, gilteritinib functions by targeting and blocking the FLT3 receptor tyrosine kinase, thus hindering the proliferation and survival of leukemia cells. Administered orally, gilteritinib presents a hopeful treatment option for AML patients who have relapsed or shown resistance to previous therapies.

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    Indication: Gilternib, also recognized as Gilteritinib in its International Nonproprietary Name (INN), is designated for treating adult patients confronting relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.

    Pharmacology: Gilternib operates as a potent and selective inhibitor targeting FLT3, a receptor tyrosine kinase that frequently undergoes mutation in AML. By specifically obstructing FLT3, gilternib effectively curtails the proliferation and survival of leukemia cells bearing FLT3 mutations, thereby halting disease advancement.

    Dosage and Administration: The recommended dose of Gilternib is 40 mg orally administered once daily. Its administration should continue uninterrupted until either disease progression or intolerable adverse reactions occur. Gilternib can be ingested with or without food.

    Interactions: Gilternib’s interactions may involve drugs that function as substrates, inhibitors, or inducers of cytochrome P450 enzymes, particularly CYP3A4. Caution is warranted when combining gilternib with potent CYP3A4 inhibitors or inducers. Additionally, vigilance is advised when co-administering with medications that extend the QT interval or are sensitive substrates of P-glycoprotein.

    Side Effects: Common side effects associated with Gilternib include myalgia, fatigue, diarrhea, nausea, increased liver enzyme levels, and febrile neutropenia. Serious adverse reactions may encompass differentiation syndrome, posterior reversible encephalopathy syndrome (PRES), and QT interval prolongation.

    Precautions and Warnings:

    • Patients should undergo vigilant monitoring for symptoms indicative of differentiation syndrome, such as fever, dyspnea, and pulmonary infiltrates.
    • Regular monitoring of liver function tests is advisable during the course of gilternib treatment.
    • Electrocardiograms (ECGs) are recommended before initiating therapy and periodically thereafter to monitor for QT interval prolongation.
    • Due to its potential for embryo-fetal toxicity, effective contraception measures should be employed during gilternib treatment and for at least six months following the final dose.

    Overdose Effect: In instances of overdose, supportive care is essential. No specific antidote for gilternib overdose exists; therefore, close monitoring for adverse reactions is crucial, with prompt initiation of appropriate symptomatic treatment as required.

    Product Name

    Gilternib

    Generic Name

    Gilteritinib INN

    Formulation

    Tablet

    Available Pack Size

    90 Tablets

    Available Strength

    40 mg