TIBSOVO

• Ivosidenib can cause irregular heartbeat and patients must be regularly monitored by assessing the electrolytes level and ECG.​‍​​​​​‍​‍‍‍‍​‍‍ Discontinue ivosidenib treatment if any symptoms and signs of abnormal heart rhythm occur. • Patients may experience symptoms of differentiation syndrome such as fever, difficulty in breathing, low blood pressure, lung infection, and rashes along with high levels of white blood cells or leukocytosis anywhere between the first day and three months of ivosidenib treatment. • Differentiation syndrome can be managed by administering dexamethasone 10 mg directly into the vein every 12 hours. • If the presence of non-infectious leukocytosis is confirmed, patients should be treated with hydroxyurea or leukapheresis, a laboratory procedure to remove white blood cells from the blood. • The dose of steroids (dexamethasone) and hydroxyurea can be reduced gradually for three days when the symptoms and signs of differentiation syndrome with leukocytosis are under control. • If the side effects do not subside within 48 hours even after initiating steroid treatment, stop ivosidenib treatment temporarily until the side effects are reduced. • Monitor the patients for any new signs or symptoms such as muscle weakness, burning or prickling sensation, numbness and pain either one side or both side of the body, changes in taste, vision or hearing during treatment with ivosidenib. • During such situations treatment with ivosidenib should be permanently stopped; otherwise patients are vulnerable to develop a rare neurological autoimmune disorder called Guillain Barré syndrome.