Ivosidenib Application Scope

Treatment of adult patients with acute myeloid leukemia (AML) with a susceptible IDH1 mutation:

As monotherapy for relapsed or refractory AML.
As monotherapy or in combination with azacitidine for newly diagnosed AML patients ≥75 years old or those unfit for intensive chemotherapy.

Ivosidenib Characteristics

Ingredients: Active ingredient: Ivosidenib (as ivosidenib fumarate).
Properties: An oral small-molecule inhibitor of mutated isocitrate dehydrogenase-1 (IDH1), promoting differentiation of leukemic cells and inhibiting tumor growth.
Packaging Specification: 250 mg film-coated tablets, supplied in blister packs or bottles
Storage: Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F). Protect from moisture and light.
Expiry Date: As indicated on the package (typically 24–36 months from manufacture).
Executive Standard: Manufactured according to international GMP and regulatory standards.
Approval Number: As issued by the relevant health authority (e.g., FDA, EMA).
Date of Revision: See the latest prescribing information update.
Manufacturer: Originally developed by Agios; marketed in many regions by Servier Pharmaceuticals.

Dosage and Administration:
- Recommended Dose: 500 mg orally once daily (two 250 mg tablets). Continue until disease progression or unacceptable toxicity.
- Administration: Take at the same time each day, with or without food. Swallow tablets whole; do not crush or chew.
- Missed Dose: If a dose is missed or vomited, take the next scheduled dose at the regular time. Do not double up doses.
Adverse Reactions:
- Common Adverse Reactions:
  - Fatigue
  - Diarrhea
  - Nausea
  - Edema
  - Joint or muscle pain
  - Decreased blood counts (anemia, leukopenia, thrombocytopenia)
  - Elevated liver enzymes (ALT/AST)
  - Electrolyte abnormalities
- Serious Adverse Reactions:
  - Differentiation syndrome (potentially life-threatening; requires prompt corticosteroid treatment)
  - QT prolongation (risk of ventricular arrhythmias)
  - Severe hepatotoxicity
  - Pancreatitis
  - Infections (sometimes fatal)
  - Rare: Posterior reversible encephalopathy syndrome (PRES)
Contraindications: Known hypersensitivity to ivosidenib or any component of the formulation.
Precautions:
- Monitor ECGs and electrolytes due to risk of QT prolongation.
- Monitor for signs of differentiation syndrome; initiate corticosteroids immediately if suspected.
- Regular monitoring of liver function, pancreatic enzymes, and complete blood counts.
- Use caution in patients with severe hepatic or renal impairment.

CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): Increase ivosidenib exposure → risk of toxicity.
CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort): Decrease exposure → reduced efficacy.
QT-prolonging drugs (e.g., amiodarone, sotalol, fluoroquinolones): Additive risk of cardiac arrhythmia.
P-gp and other transporter substrates: Potential interactions; monitor closely.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.