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Another NameLuciVos、依维替尼、ivosidenib、Tibsovo
IndicationsIvosidenib is suitable for acute myeloid leukemia and Carcinoma of bile duct.
Reg No.07 L 0988/23
Inspection NO.
On July 20, 2018, Ivosidenib (trade name: Tibsovo) was approved by the FDA for use in the treatment of adult patients with recurrent or refractory acute myeloid leukemia (AML) with IDH1 mutations.
The original manufacturer of Ivosidenib is Agios Pharmaceuticals.
Ivosidenib can target the IDH1 metabolic pathway, inhibit the activity of mutated IDH1 enzymes, and prevent the accumulation of metabolite 2-HG, thereby playing an anti-cancer role.
Ivosidenib
Ivosidenib is suitable for acute myeloid leukemia and Carcinoma of bile duct.
Based on animal embryo-fetal toxicity studies, Ivosidenib may cause fetal harm when administered to a pregnant woman. There are no available data on Ivosidenib use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In animal embryo-fetal toxicity studies, oral administration of ivosidenib to pregnant rats and rabbits during organogenesis was associated with embryo-fetal mortality and alterations to growth starting at 2 times the steady state clinical exposure based on the AUC at the recommended human dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus.
There are no data on the presence of ivosidenib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with Ivosidenib and for 1 month after the last dose.
The safety and effectiveness of Ivosidenib in pediatric patients have not been established.
Of the 304 patients who received Ivosidenib in the clinical studies for AML and MDS, 75% were 65 years of age or older and 35% were 75 years or older. Of the 124 patients with cholangiocarcinoma treated with Ivosidenib in Study AG120-C-005, 37% were 65 years of age or older and 11% were 75 years or older. No overall differences in effectiveness or safety were observed between patients who were 65 years and older compared to younger patients.
No modification of the starting dose is recommended for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2 , MDRD). The pharmacokinetics and safety of ivosidenib in patients with severe renal impairment (eGFR < 30 mL/min/1.73m2 , MDRD) or renal impairment requiring dialysis are unknown. For patients with pre-existing severe renal impairment or who are requiring dialysis, consider the risks and potential benefits before initiating treatment with Ivosidenib.
No modification of the starting dose is recommended for patients with mild or moderate (Child-Pugh A or B) hepatic impairment. The pharmacokinetics and safety of ivosidenib in patients with severe hepatic impairment (Child-Pugh C) are unknown. For patients with pre-existing severe hepatic impairment, consider the risks and potential benefits before initiating treatment with Ivosidenib.
Drug overdose is not yet clear.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
The AUC and Cmax of ivosidenib increase in a less than dose-proportional manner from 200 mg to 1,200 mg daily (0.4 to 2.4 times the approved recommended dosage). The following ivosidenib pharmacokinetic parameters were observed following administration of ivosidenib 500 mg as a single dose or daily dose (for steady state), unless otherwise specified. The steady-state pharmacokinetics of ivosidenib 500 mg were comparable between patients with newly diagnosed AML, relapsed or refractory AML, and relapsed or refractory MDS, and were lower in patients with cholangiocarcinoma.
from FDA，2023.10
