Ivosidenib is a targeted therapeutic drug for relapsed or refractory acute myeloid leukemia (AML) in patients with isocitrate dehydrogenase 1 (IDH1) mutation. This article will provide a comprehensive overview of Ivosidenib's usage methods, precautions, and pharmacological properties from three aspects: basic drug information, drug interactions, and pharmacokinetics, to help patients and healthcare professionals better understand this medication.

Ivosidenib Package Insert

Ivosidenib is an oral targeted drug mainly used for the treatment of AML patients with IDH1 mutation. Its unique pharmacological mechanism makes it an important treatment option for specific patient populations.

Indications, Dosage and Administration

Ivosidenib is indicated for adult patients with relapsed or refractory AML who have been confirmed to have IDH1 mutation through testing. The recommended dose is 500 mg, taken orally once daily, until disease progression or the occurrence of intolerable toxicity. The medication can be taken on an empty stomach or after meals, but high-fat diets should be avoided as they may affect the drug's efficacy.

Adverse Reactions and Precautions

Common adverse reactions include fatigue, arthralgia, and diarrhea. Special attention should be paid to severe side effects such as differentiation syndrome and QT interval prolongation, and timely intervention measures should be taken. During the medication period, regular monitoring of electrocardiogram (ECG) and blood biochemical indicators is required.

The use of Ivosidenib must strictly follow the doctor's advice. Patients should fully understand its indications and potential risks, and be aware of the safety of the treatment.

Drug Interactions of Ivosidenib

Drug interactions may affect the efficacy of Ivosidenib or increase the risk of adverse reactions. Understanding these interactions is of great importance for clinical medication.

Interactions with Other Drugs

Strong CYP3A4 inducers can reduce the plasma concentration of Ivosidenib, and concurrent use should be avoided. When used in combination with strong CYP3A4 inhibitors, the dose of Ivosidenib needs to be adjusted to 250 mg once daily, and the original dose should be resumed after discontinuing the inhibitor.

Interactions with Antacids

Gastric acid-lowering agents may reduce the concentration of Ivosidenib, and concurrent use with proton pump inhibitors (PPIs) and other similar drugs is recommended to be avoided. If their use is necessary, the medication time should be staggered to minimize the impact.

Reasonable management of drug interactions is crucial to ensure the efficacy of Ivosidenib. During clinical medication, the patient's concurrent medication status should be fully evaluated.

Pharmacokinetics of Ivosidenib

Pharmacokinetic characteristics determine the absorption, distribution, and metabolism processes of the drug in the body, which directly affect its therapeutic effect.

Absorption and Distribution

After a single dose administration, the mean peak plasma concentration (Cmax) is 4,503 ng/mL, and the steady-state concentration is 6,551 ng/mL. The area under the concentration-time curve (AUC) is 117,348 ng·hr/mL, indicating that the drug has good exposure in the body.

Metabolism and Excretion

Ivosidenib is mainly metabolized by CYP3A4, and caution should be exercised when administering it to patients with hepatic impairment. Patients with mild or moderate renal impairment do not need dose adjustment, but for patients with severe renal impairment, the risks and benefits need to be evaluated.

Understanding the metabolic characteristics of Ivosidenib is helpful for optimizing the dosage regimen and providing personalized treatment for different patient populations.