ALIIVOSIDENIB IVOSIDENIB 250 MG 60'S Approval No. 07 L 1130/24 Expiry Date 11-6-2027

Ivosidenib Tablets

【 Generic name 】Ivosidenib tablets

【 Brand name 】ALIIVOSIDENIB

【 Main ingredients 】 Ivosidenib……….250 mg.

[ Indications ] Newly diagnosed acute myeloid leukemia; relapsed or refractory acute myeloid leukemia; cholangiocarcinoma.

【 Usage and Dosage 】

• Oral, 500 mg, once daily, with or without food, until disease progression or unacceptable toxicity. Avoid high-fat diet.
• If the QTc interval increases to 480-500 milliseconds, reduce or interrupt ivosidenib. Permanently discontinue ivosidenib in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmias.

【 Taboo 】None.

【 Notes 】

1. Pregnant women, children and elderly patients should take medication according to doctor's advice.
2. Breastfeeding women should stop breastfeeding while taking the medicine.
3. QTc interval prolongation
4. Guillain-Barré Syndrome: Monitor patients for new signs and symptoms, motor and/or sensory findings. Permanently discontinue ivosidenib in patients diagnosed with Guillain-Barré syndrome.

【 Adverse Reactions 】

1. The most common adverse reactions in patients with AML were fatigue, arthralgia, leukocytosis, diarrhea, edema, nausea, dyspnea, mucositis, QTc interval prolongation, rash, cough, decreased appetite, myalgia, constipation, and pyrexia.
2. The most common adverse reactions in patients with cholangiocarcinoma were fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash.

【 Properties 】Blue tablets.

【 Validity period 】2 years from the date of production.

【 Package 】60 tablets/bottle

【 Storage 】

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

【 Manufacturer 】

Laos United Pharmaceutical Group Factory.

Saysettha Development Zone, Vientiane, Lao People's Democratic Republic