Ivosidenib Dose Adjustment with Strong CYP3A4 Inhibitors
1.If coadministration is unavoidable:reduce ivosidenib dose to 250 mg once daily.
2.After discontinuation of the inhibitor:after the inhibitor has been washed out for ≥5 half-lives,resume ivosidenib to 500 mg once daily.
Black Box Warning:Differentiation Syndrome in Acute Myeloid Leukemia
(1)May be fatal.Symptoms include fever,dyspnea,hypoxia,pulmonary infiltrates,pleural/pericardial effusion,rapid weight gain/edema,hypotension,and hepatic/renal/multiorgan dysfunction.
(2)If suspected,initiate corticosteroids immediately and maintain hemodynamic monitoring until symptom resolution.
Contraindications for Ivosidenib
No absolute contraindications.
Patient Monitoring for Ivosidenib
1.Electrocardiogram
Before treatment,at least weekly during the first 3 weeks of therapy,then at least monthly thereafter.
2.Patients with Acute Myeloid Leukemia
(1)Complete blood count and serum chemistry:before treatment,weekly during the first month,every 2 weeks during the second month,then monthly thereafter.
(2)Creatine phosphokinase(CPK):weekly during the first month.
Storage Conditions for Ivosidenib
Store at 20°C–25°C(68°F–77°F);excursions permitted between 15°C–30°C(59°F–86°F).
Important Reminders
1.Report the following symptoms urgently:
(1)Differentiation syndrome(fever,cough,dyspnea,rash,decreased urine output,hypotension,edema,sudden weight gain).
(2)QTc prolongation-related symptoms(dizziness,syncope).
(3)Guillain-Barré syndrome(limb weakness,numbness,pain,paresthesia,dyspnea).
2.To prevent tumor lysis syndrome,maintain adequate hydration and monitor serum chemistry regularly.
3.Report gastrointestinal reactions promptly(diarrhea,nausea,mucositis,constipation,vomiting,decreased appetite,ascites,abdominal pain).
4.Breastfeeding is contraindicated(during treatment and for 1 month after the last dose).
