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Ivosidenib(Tibsovo)

Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection

Reference price:

Manufacturer:

Formulation:

TABLET

Validity period:

Not specified in the specification.

Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

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

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.

Therapeutic Target

Mutant isocitrate dehydrogenase-1 (IDH1) enzyme.

Active Ingredients

Ivosidenib

Dosage form

TABLET

specifications

60-count bottle containing 250 mg tablets with a desiccant canister (NDC 72694-617-60).

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

Recommended Dosage: 500 mg orally once daily until disease progression or unacceptable toxicity.

Administration:

Swallow whole; do not split, crush, or chew.

Take with or without food; avoid high-fat meals.

If vomiting occurs, skip the dose; resume next scheduled dose.

If a dose is missed, take within 12 hours of the scheduled time.

Combination Therapy (Newly Diagnosed AML):

Start TIBSOVO on Cycle 1 Day 1 with azacitidine (75 mg/m² SC/IV on Days 1–7 or Days 1–5 and 8–9 of a 28-day cycle).

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