Ivosidenib(Tibsovo)
Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection
Reference price:
Manufacturer:
‌Agios Pharmaceuticals
Formulation:
TABLET
Validity period:
24 months
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Pharmacological Profile and Mechanism of Action

Ivosidenib is a targeted small-molecule inhibitor of mutant isocitrate dehydrogenase-1 (IDH1), an enzyme implicated in oncogenic metabolism. By selectively binding to mutant IDH1 variants (e.g., R132H/C/G/L/S), it suppresses the production of the oncometabolite 2-hydroxyglutarate (2-HG), thereby restoring cellular differentiation and reducing leukemic or tumor cell proliferation. This mechanism is validated across hematologic malignancies and solid tumors, with clinical efficacy demonstrated in IDH1-mutated AML, MDS, and cholangiocarcinoma.

Clinical Efficacy and Safety Overview

TIBSOVO has shown significant clinical benefit in pivotal trials (e.g., AG120-C-009, AG120-C-001), including improved event-free survival (HR: 0.35) and overall survival (HR: 0.44) in newly diagnosed AML when combined with azacitidine. As monotherapy, it induces durable complete remissions (CR: 24.7% in relapsed/refractory AML) and objective responses in cholangiocarcinoma. Administered orally at 500 mg once daily, it requires vigilant monitoring for differentiation syndrome (15–25% incidence), QTc prolongation (14% with QTcF >500 ms), and Guillain-Barré syndrome (0.8%). Common adverse reactions include cytopenias, gastrointestinal disturbances, and electrolyte imbalances. Dose modifications are mandated for toxicity management, particularly with concomitant CYP3A4 inhibitors or QTc-prolonging agents.

Generic name

Ivosidenib(Tibsovo)
English name
Ivosidenib
Alternative Names
Tibsovo
Drug prices
Indications

Ivosidenib is indicated for the diagnosis of relapsed or refractory acute myeloid leukemia (AML) harboring a susceptible isocitrate dehydrogenase-1 (IDH1) mutation using a well-validated test.

Therapeutic Target
Mutant isocitrate dehydrogenase-1 (IDH1) enzyme.
Active Ingredients
Ivosidenib
Dosage form
TABLET
specifications
250mg*60 tablets/box
Description
TIBSOVO is indicated for adults with susceptible IDH1 mutations detected by an FDA-approved test in:

Newly Diagnosed Acute Myeloid Leukemia (AML):

As monotherapy or in combination with azacitidine for patients ≥75 years or those with comorbidities precluding intensive induction chemotherapy.

Relapsed/Refractory AML

Relapsed/Refractory Myelodysplastic Syndromes (MDS)

Locally Advanced or Metastatic Cholangiocarcinoma:

Previously treated patients.

Dosage and Administration

500 mg orally, once a day, with or without food, avoid high-fat diets.

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