LuciVos IVOSIDENIB 250 MG 60'S Approval No. 07 L 0988/23 Expiry Date 20-7-2026

Ivosidenib Instructions

 

Product Name: LuciVos

Manufacturer : Lucius Pharmaceuticals

Chinese name : Ivosidenib

English Name: Ivosidenib

Drug approval number: 07 L 0988/23

 

【Summary】

Ivosidenib is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 ( IDH1 ) enzyme.

Susceptible IDH1 mutations were defined as those that result in elevated 2- hydroxyglutarate ( 2-HG ) levels in leukemic cells for which efficacy was predicted by 1 ) clinically recommended doses of ivosidenib and / or 2 ) inhibition of mutant IDH1 enzyme activity at ivosidenib concentrations that were sustained at the recommended dose according to validated methods.

The most common of these mutations are R132H and R132Cs substitutions.

Ivosidenib inhibits selected IDH1 R132 mutants in vitro at much lower concentrations than wild-type IDH1 . Inhibition of the mutant IDH1 enzyme by ivosidenib leads to reduced 2HG levels and induces myeloid differentiation in vitro and in vivo in a mouse xenograft model .

 

【Indications】

Ivosidenib is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia ( AML ) diagnosed with a susceptible isocitrate dehydrogenase -1 ( IDH1 ) mutation as determined by a fully validated test .

 

【Specification】  

250mg/ tablet , 60 tablets / box

 

【Storage】

Store at 20°C to 25°C (68°C to 77°F) ; short-distance transport is permitted within the temperature range of 15 to 30°C (59–86°F) .

 

【Usage and Dosage】

Patient selection

Before using ivosidenib to treat adult patients with relapsed or refractory acute myeloid leukemia ( AML ), it is necessary to confirm that the patient has an isocitrate dehydrogenase -1 ( IDH1 ) mutation in the bone marrow or peripheral blood. A fully validated test method should be used to determine the patient's IDH1 mutation status. Patients who are diagnosed with an IDH1 mutation by the hospital or laboratory's IDH1 mutation test results can receive ivosidenib treatment.

Recommended dose

The recommended dose is 500 mg , once a day, which can be taken orally on an empty stomach or after a meal until disease progression or unacceptable toxicity occurs. Patients who do not experience disease progression or unacceptable toxicity need to receive at least 6 months of treatment to fully observe clinical responses.

Ivosidenib may be taken with or without food. Avoid taking it with high-fat foods. Swallow the tablet whole; do not break, crush, or chew the tablet.

Take the medicine at the same time every day. If vomiting occurs after taking the medicine, do not take it again. Take the next dose at a normal time the next day.

If you miss a dose or do not take it at the scheduled time, take it as soon as possible (at least 12 hours before the next scheduled dose); however, if it is less than 12 hours before the next scheduled dose, you do not need to make up the dose and resume your normal medication schedule the next day. Do not take the drug twice within 12 hours .

Monitoring for toxicity

Check blood counts and blood biochemistry before the first dose, at least once a week in the first month of treatment, every two weeks in the second month of treatment, and monthly thereafter during treatment. Monitor blood creatine phosphokinase once a week during the first month of treatment. Perform an electrocardiogram ( ECG ) at least once a week during the first three weeks of treatment, and at least once a month thereafter during treatment . Any abnormal findings should be addressed promptly.

Dosage Adjustment for Coadministration with Strong CYP3A4 Inhibitors

If co-administration with a strong CYP3A4 inhibitor is necessary, the dose of this product should be reduced to 250 mg once daily. At least 5 half-lives after cessation of treatment with the strong CYP3A4 inhibitor , this product can be resumed to the recommended dose of 500 mg once daily.

 

【Use during pregnancy and lactation】

contraception

Female patients of childbearing potential and male patients with female partners of childbearing potential should use effective contraception during treatment and for at least 1 month after the last dose. Co-administration with this product may reduce the concentration of hormonal contraceptives. Patients receiving this product should use other contraceptive methods during treatment and for at least 1 month after the last dose . Women of childbearing potential should undergo pregnancy testing before starting treatment with this product.

Pregnant women

Pregnant women receiving this drug may cause harm to the fetus. If this drug is taken during pregnancy, or the patient becomes pregnant while taking the drug, the patient should be informed of the potential risk to the fetus.

Lactation

There are no data on the presence of levofloxacin or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Because many drugs are excreted in human milk and adverse reactions may occur in breastfed infants, it is recommended that breastfeeding be discontinued during treatment with levofloxacin and for at least 1 month after the last dose.

Fertility

Animal and human fertility toxicity studies have not been conducted on this product.

 

【Adverse Reactions】

1. The most common adverse reactions ( ≥20 %) are fatigue, leukocytosis, arthralgia, diarrhea, dyspnea, edema, nausea, mucositis, QT prolongation on ECG, rash, fever, cough and constipation.

2. The most common laboratory abnormalities ( ≥20% ) include decreased hemoglobin, decreased calcium, decreased sodium, decreased magnesium, increased uric acid, decreased potassium, increased alkaline phosphatase, increased aspartate aminotransferase, decreased phosphate, and increased creatinine.

 

[Special Populations]

Hepatic insufficiency

No adjustment in the starting dose is required for patients with mild or moderate (Child-Pugh A or B) hepatic impairment.

The pharmacokinetics and safety of ivosidenib tablets in patients with severe hepatic impairment (Child-Pugh C) are not well established. The risks and potential benefits of ivosidenib tablets should be considered before initiating treatment in patients with pre-existing severe hepatic impairment.

Renal insufficiency

No adjustment of the starting dose is required 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 not well established. The risks and potential benefits of ivosidenib should be considered before initiating treatment in patients with pre-existing severe renal impairment or requiring dialysis.

Elderly

No dose adjustment is required for elderly patients.

child

There is no clinical research data on the use of this product in patients under 18 years old.