ALIIVOSIDENIB

COMPOSITION
Ivosidenib……………………………………….250mg

INDICATIONS
• Newly diagnosed acute myeloid leukemia; Recurrent or refractory acute myeloid leukemia; Bile duct cancer.

PACKAGING: 60 Tablets/box.
Reg No: 07 L 1130/24
Download ALIIVOSIDENIB Drug Registration Certificate


Brand name: ALIIVOSIDENIB


Composition:
Each tablet contains:
Ivosidenib……………………………………….250mg


Indication:
Newly diagnosed acute myeloid leukemia; Recurrent or refractory acute myeloid leukemia; Bile duct cancer.


Dosage:
• 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. Avoid a high-fat meal.
• If the QTc interval increases to 480-500 milliseconds, the Ivosidenib dose is reduced or interrupted. For patients with prolonged QTc interval and life-threatening arrhythmia signs or symptoms, Ivosidenib needs to be permanently discontinued.


Contraindications: None.


Warning:
• Pregnant women, children and elderly patients should follow the doctor’s advice.
• Breastfeeding women should stop breastfeeding while taking medication.
• QTc Interval Prolongation
• Guillain-Barré Syndrome: Monitor patients for signs and symptoms of new
• motor and/or sensory findings. Permanently discontinue Ivosidenib in patients who are diagnosed with Guillain-Barré syndrome.


Adverse effects:
• The most common adverse events in patients with acute myeloid leukemia are fatigue, arthralgia, leukocytosis, diarrhea, edema, nausea, dyspnea, mucositis, prolonged QT interval, rash, cough, loss of appetite, myalgia, constipation, and fever.
• The most common adverse reactions in patients with cholangiocarcinoma are fatigue, nausea, abdominal pain, diarrhea, cough, loss of appetite, ascites, vomiting, anemia, and rash.


Dosage form: Blue tablets.


Expiry date24 months after date of manufacture.


Packaging: 60 tablets per bottle.


Storage:
• Store at room temperature 20-25℃.
• Keep out of reach of children.


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