艾伏尼布的用药注意事项

Avosidenib is an oral targeted drug targeting IDH1 mutations, mainly used to treat relapsed or refractory acute myeloid leukemia (AML). As a prescription drug, strict attention must be paid to a number of medication precautions during its use.

Precautions for use of ivosidenib

1. Differentiation syndrome in acute myeloid leukemia and myelodysplastic syndrome

It has been reported that differentiation syndrome may occur during treatment with IDH1 inhibitors (such as ivosidenib), and this syndrome has been observed as early as 1 day to 3 months after starting ivosidenib treatment.

If no alternative etiology is clear, differentiation syndrome should be suspected.

If signs or symptoms suggestive of differentiation syndrome occur, intravenous or oral corticosteroid therapy (e.g., dexamethasone 10 mg IV every 12 hours [or equivalent]) should be initiated and continued for at least 3 days until symptoms subside, followed by a gradual reduction of the corticosteroid dose and monitoring of hemodynamic parameters until symptoms improve.

If leukocytosis without infectious etiology occurs concurrently, hydroxyurea therapy should be initiated according to standard practice and leukapheresis performed as needed.

If signs or symptoms of differentiation syndrome persist for more than 48 hours despite corticosteroid therapy, ivosidenib therapy should be discontinued.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

2. QT interval prolongation

There are reports of QTc interval prolongation and ventricular arrhythmia (ie, ventricular fibrillation).

Monitor ECG at least weekly during the first 3 weeks of treatment and at least monthly thereafter.

Monitor blood chemistry markers at baseline, at least weekly during the first month of treatment, every two weeks for the next month, and monthly thereafter. Correct electrolyte abnormalities as clinically indicated before initiating treatment with ivosidenib and during treatment.

If QTc interval prolongation occurs, it may be necessary to temporarily interrupt, reduce the dose, or discontinue ivonib. Monitor the ECG at least weekly until two weeks after resolution of the QTc interval prolongation.

3. Guillain-Barré syndrome

There are rare reports of Guillain-Barré syndrome.

Monitor for signs or symptoms of motor and/or sensory neuropathy (e.g., unilateral or bilateral weakness, sensory changes, paresthesia, dyspnea). If Guillain-Barré syndrome occurs, ivosidenib should be discontinued.

Common adverse reactions of ivosidenib

1. Patients with acute myeloid leukemia (AML)

Common adverse reactions (including laboratory abnormalities, ≥25%): leukopenia, diarrhea, reduced hemoglobin, thrombocytopenia, elevated blood sugar, fatigue, elevated alkaline phosphatase, edema, Decreased serum potassium, nausea, vomiting, decreased serum phosphate, decreased appetite, decreased serum sodium, leukocytosis, decreased serum magnesium, increased aspartate aminotransferase (AST), joint pain, dyspnea, increased uric acid, abdominal pain, increased creatinine, mucositis, rash, prolongation of the QT interval, differentiation syndrome, decreased serum calcium, neutropenia, and myalgia.

2. Patients with relapsed or refractory myelodysplastic syndrome (MDS)

Common adverse reactions (including laboratory abnormalities, ≥25%): increased creatinine, decreased hemoglobin, joint pain, decreased albumin, increased aspartate aminotransferase (AST), fatigue, diarrhea, cough, decreased serum sodium, mucositis, decreased appetite, myalgia, decreased serum phosphate, pruritus and rash.

3. Patients with cholangiocarcinoma

Common adverse reactions (≥15%): fatigue, nausea, abdominal pain, diarrhea, cough, loss of appetite, ascites, vomiting, anemia and rash. Common laboratory abnormalities (≥10%) in patients with cholangiocarcinoma: decreased hemoglobin, increased aspartate aminotransferase (AST), and increased bilirubin.