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Ivonib is an oral isocitrate dehydrogenase-1 (IDH1) inhibitor. By targeting the activity of the mutant IDH1 enzyme, it reduces the production of the carcinogenic metabolite 2-hydroxyglutarate (2-HG), thereby inducing malignant cell differentiation and inhibiting tumor growth.
1. Generic name: Ivosidenib (Ivosidenib)
2. Trade name: TIB SOVO®
It is suitable for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who are confirmed by FDA-approved testing to carry susceptible IDH1 mutations.
1. Specifications: 250mg/tablet;
2. Properties: tablets.
Active ingredient: Avosidenib; excipients include colloidal silica, croscarmellose sodium, hypromellose acetate succinate, etc.
1. Conventional dosage of : 500 mg orally, once a day, with a meal or on an empty stomach, avoid high-fat diet.
2. Treatment of missed doses : If you miss a dose, take it again within 12 hours; if you vomit, there is no need to take it again, just take the next dose as originally planned.
3. Treatment course :Continue to take the drug until the disease progresses or unacceptable toxicity occurs, for at least 6 months to evaluate the efficacy.
1. QTc prolongation : Suspend the medication when QTc >480ms, and reduce the dose to 250mg/day after recovery; if QTc >500ms or arrhythmia occurs, discontinue medication permanently.
2. Differentiation syndrome : It is necessary to suspend the medication and give glucocorticoid treatment, and resume medication after the symptoms are relieved.
3. Combined use of strong CYP3A4 inhibitor : Reduce the dose to 250mg/day.
1. Dietary influence : Avoid taking with high-fat meals (such as fried eggs, bacon, whole milk).
2. Drug interactions : Avoid the combined use of strong CYP3A4 inducers (such as rifampicin) or QTc prolonging drugs (such as fluoroquinolones).
3. Monitoring requirements : In the early stage of treatment, electrocardiogram, blood routine and electrolytes need to be monitored weekly.
1. Pregnant women : may cause fetal damage, so contraception is required during medication.
2. Lactation : Breastfeeding is prohibited for at least 1 month after stopping the drug.
3. Elderly patients : No dose adjustment is required, but monitoring is required.
1. Common (≥20%): Including fatigue, leukocytosis, joint pain, diarrhea, dyspnea, edema, nausea, mucositis, etc.;
2. Serious adverse reactions: Including differentiation syndrome (19%), QTc prolongation (9%), Guillain-Barré syndrome (<1%).
There are no clear contraindications, but it is prohibited for those who are allergic to the ingredients.
1. CYP3A4 inhibitor : Increases the plasma concentration of ivonib, and the dose needs to be adjusted.
2. Hormonal contraceptive : It may reduce the effectiveness of the drug, so it is recommended to use non-hormonal contraceptive measures.
12. Storage method
Save at room temperature (20°C-25°C) and avoid moisture.