Adverse reactions of Ivosidenib

This product may cause some adverse reactions during treatment. Patients should carefully read the following information and closely monitor their physical responses during medication. If any discomfort occurs, please inform your doctor promptly.

Serious Adverse Reactions Possibly Caused by Ivosidenib

Differentiation Syndrome

Differentiation syndrome is a common condition affecting blood cells, which can be life-threatening or fatal. In adult patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), differentiation syndrome may occur as early as 1 day to 3 months after the initiation of ivosidenib treatment. During ivosidenib therapy, if you experience any of the following symptoms of differentiation syndrome, contact your doctor immediately or go to the emergency department of the nearest hospital:

Fever, cough, dyspnea, skin rash, decreased urine output, dizziness or lightheadedness, rapid weight gain, swelling of the arms and legs.

If signs and symptoms of differentiation syndrome appear, your doctor may treat you with corticosteroids or a drug called hydroxyurea, and you may be hospitalized for monitoring.

Changes in Cardiac Electrical Activity (Known as QT Prolongation)

QT prolongation may lead to life-threatening arrhythmias. Your doctor will examine your cardiac electrical activity via electrocardiogram (ECG) before and during ivosidenib treatment. If you feel dizzy, lightheaded or faint, inform your doctor immediately.

Guillain-Barré Syndrome

Your doctor will monitor you for neurological problems. If you develop Guillain-Barré syndrome, ivosidenib treatment will be permanently discontinued. If you experience any signs or symptoms of Guillain-Barré syndrome, notify your doctor immediately, including:

Weakness or tingling sensations in the legs, arms or upper body; numbness and pain on one or both sides of the body; any changes in vision, touch, hearing or taste; burning or prickling sensations; dyspnea.

In Adult Patients with AML

The most common adverse reactions of ivosidenib, whether used in combination with azacitidine or as monotherapy, include:

Changes in certain blood cell counts, diarrhea, hyperglycemia, fatigue, changes in certain liver function test parameters, swelling of the arms or legs, decreased electrolyte levels in the blood, nausea, vomiting, decreased appetite, arthralgia, shortness of breath, hyperuricemia, stomach (abdominal) pain, changes in certain renal function test parameters, pain or ulcers in the mouth or throat, skin rash, irregular heart rhythm or beat (QT prolongation), differentiation syndrome, myalgia.

In Adult Patients with MDS

The most common adverse reactions of ivosidenib include:

Changes in certain renal function test parameters, changes in certain blood cell counts, arthralgia, back or neck pain, decreased albumin levels in the blood, changes in liver function test parameters, fatigue, diarrhea, cough, decreased sodium levels in the blood, pain or ulcers in the mouth or throat, decreased appetite, myalgia, decreased phosphorus levels in the blood, pruritus, skin rash.

In Adult Patients with Cholangiocarcinoma

The most common adverse reactions of ivosidenib include:

Fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, abdominal effusion and swelling, vomiting, decreased hemoglobin (anemia), skin rash, changes in liver function test parameters.

Your doctor will perform blood tests before and during ivosidenib treatment. If certain adverse reactions occur, your doctor may reduce the dose, temporarily interrupt or permanently discontinue ivosidenib treatment.

Ivosidenib may cause fertility problems in both women and men, which may affect your ability to have children. If you have concerns about fertility, discuss them with your doctor.

from FDA，2023.10