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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. Trade name: TIBSOVO
2. Generic name: Ivosideni b)
Avosidenib is suitable for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have susceptible isocitrate dehydrogenase-1 (IDH1) mutations.
1. Specifications: 250mg.
2. Characteristics: Oral film-coated tablet dosage form.
1. Active ingredient: Ivosidenib
2. Excipients: Colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate.
1. Recommended dosage: Take 500mg once a day, orally, with or without food.
2. Administration method: Swallow the tablet whole and do not divide, crush or chew it.
1. Adjust the dose according to the severity of adverse reactions. If the QTc interval is prolonged, the medication needs to be suspended, the dose reduced to 250 mg once a day, or the medication must be permanently discontinued.
2. If co-administration with a strong CYP3A4 inhibitor is unavoidable, the dose of ivonib needs to be reduced to 250 mg once a day, and restored to 500 mg once a day after stopping the inhibitor for at least 5 half-lives.
1. Before and after meals:Avosidenib can be taken with or without food, but high-fat diet should be avoided, because high-fat diet can significantly increase the plasma concentration of ivosidenib.
2. Missed dose: If you miss a dose or do not take it at the regular time, you should take it as soon as possible, unless the next dose is taken within 12 hours, in which case you should skip the missed dose and take the next dose at the original planned time the next day.
3. Vomiting: If you vomit after taking the medicine, there is no need to take an additional dose. Take the next dose according to the original plan the next day.
1. Pregnant and lactating women: Avosidenib may be harmful to the fetus and is contraindicated in pregnant women. Breastfeeding women should not breastfeed during treatment and for at least 1 month after stopping the drug.
2. Women and men of reproductive potential: It is recommended that women of reproductive potential use effective non-hormonal contraceptive measures during treatment and for at least 1 month after stopping treatment; it is recommended that female partners of male patients use effective contraceptive measures during treatment and for at least 1 week after stopping treatment.
3. Children: The safety and effectiveness of ivonib in children have not been established.
4. Elderly people: The overall safety of patients aged 65 and above is similar to that of younger patients, but the dose needs to be adjusted according to the specific situation.
5. Hepatic and renal insufficiency: Patients with mild to moderate hepatic and renal insufficiency do not need to adjust the dose. The recommended dose for patients with severe hepatic and renal insufficiency has not yet been determined.
1. Common adverse reactions (≥20%): Fatigue, leukocytosis, joint pain, diarrhea, dyspnea, edema, nausea, stomatitis, QTc interval prolongation, rash, fever, cough and constipation.
2. Serious adverse reactions: Including differentiation syndrome, QTc interval prolongation with torsade de pointes, Guillain-Barré syndrome, etc.
There are no absolute contraindications to ivonib.
1. CYP3A4 inhibitors: Strong or moderate CYP3A4 inhibitors can increase the plasma concentration of ivonib and increase the risk of QTc interval prolongation, so combination or reduced use should be avoided.
2. CYP3A4 inducers: Strong CYP3A4 inducers can reduce the plasma concentration of ivonib and affect its efficacy, so combined use should be avoided.
3. Drugs that prolong QTc: Avoid combination with other drugs known to prolong the QTc interval to increase the risk of cardiac events.
Store at 20°C to 25°C (68°F to 77°F), with an allowed temperature fluctuation range of 15°C to 30°C (59°F to 86°F).