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LUCIVOS Lvosidenib Tablets 250mg

LUCIVOS Ivosidenib Tablets is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who carry a susceptible isocitrate dehydrogenase-1 (IDH1) mutation using a well-validated assay.

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Product name: LuciVos
Common name: Ivosidenib
Dosage form: tablet
Packing: 60 capsules
Specifications: 250mg
Origin: Laos

LUCIVOS Lvosidenib Tablets 250mg Summarize

Ivosidenib is a small molecule inhibitor that targets the mutated isocitrate dehydrogenase 1 (IDH1) enzyme. Susceptible IDH1 mutations are defined as those that result in elevated levels of 2-hydroxyglutarate (2-HG) in leukemia cells, with efficacy predicted either by 1) clinically recommended dosages of Ivosidenib and/or 2) the inhibition of mutated IDH1 enzyme activity. Through validated methods, Ivosidenib concentrations are sustained at recommended dosages.

The most common mutations in this category are R132H and R132C substitutions. Ivosidenib inhibits select IDH1 R132 mutant forms at much lower concentrations than the wild-type IDH1 in vitro. In a mouse xenograft model, Ivosidenib’s inhibition of mutant IDH1 enzymes leads to a reduction in 2HG levels and induces in vitro and in vivo myeloid differentiation.

【Indications】
Ivosidenib is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who carry a susceptible isocitrate dehydrogenase-1 (IDH1) mutation using a well-validated assay.
【Specification】
250mg/capsule, 60 capsules/bottle
【Storage】
Store at 20°C ~ 25°C (68°C ~ 77°F); short-distance transportation is allowed within the temperature range of 15~30°C (59–86°F).

LUCIVOS Lvosidenib Tablets 250mg Dosage

Patient Selection

Before using Ivosidenib to treat relapsed or refractory acute myeloid leukemia (AML) in adult patients, it is essential to confirm the patient’s bone marrow or peripheral blood carries an isocitrate dehydrogenase-1 (IDH1) mutation. A fully validated testing method should be employed to determine the patient’s IDH1 mutation status. Patients whose hospital or laboratory test results confirm the presence of IDH1 mutation are eligible for treatment with Ivosidenib.

Recommended Dosage

The recommended dosage is 500 mg once daily, either on an empty stomach or after a meal, until disease progression or the development of intolerable toxicity. Patients who do not experience disease progression or intolerable toxicity should receive treatment for a minimum of 6 months to observe clinical responses fully.

Ivosidenib can be taken on an empty stomach or after a meal. Avoid taking it with high-fat foods. The tablet should be swallowed whole, without breaking, crushing, or chewing it.

Take the medication at the same time every day. If vomiting occurs after taking the medication, do not take an additional dose. Resume the regular dosing schedule the following day.

If a dose is missed or not taken at the scheduled time, it should be taken as soon as possible (at least 12 hours before the next scheduled dose). However, if the time until the next scheduled dose is less than 12 hours, there is no need to take the missed dose. Resume the regular dosing plan the next day. Do not take two doses within 12 hours.

Breastfeeding: It is recommended that women do not breastfeed.

Toxicity Monitoring

Prior to the first dose, weekly blood cell counts, and blood chemistry should be checked at least once a week during the first month of treatment, then every two weeks in the second month, and monthly throughout the treatment period. In the first month of treatment, creatine kinase should be monitored weekly. In the first three weeks of treatment, electrocardiograms (ECGs) should be performed at least once a week, followed by monthly ECGs during the treatment period. Any abnormal findings should be promptly addressed.

Dose Adjustment with Strong CYP3A4 Inhibitors

If co-administration with strong CYP3A4 inhibitors is necessary, the dose of this drug should be reduced to 250 mg once daily. After discontinuation of treatment with strong CYP3A4 inhibitors, the drug can be resumed at the recommended dose of 500 mg once daily, following a minimum of 5 half-lives.

LUCIVOS Lvosidenib Tablets 250mg for pregnant and lactating women

Contraception

Female patients of childbearing potential and male patients with female partners of childbearing potential should use effective contraception for at least one month during treatment and after the last dose. Co-administration with this drug may reduce the concentration of hormonal contraceptives. Patients undergoing treatment with this drug should use alternative contraceptive methods for at least one month during treatment and after the last dose. Women of childbearing potential should undergo a pregnancy test before starting this treatment.

Pregnant Women

Treatment with this drug during pregnancy may harm the fetus. Patients who take this drug during pregnancy or become pregnant during treatment should be informed of the potential risks to the fetus.

Breastfeeding

There is no available data on the presence of this drug or its metabolites in human milk, its impact on breastfeeding infants, or its effects on milk production. Since many drugs can be excreted into human milk and may cause adverse reactions in breastfed infants, it is recommended to discontinue breastfeeding for at least one month during treatment with this drug and after the last dose.

LUCIVOS Lvosidenib Tablets 250mg Adverse reactions

  1. The most common adverse reactions (≥20%) include fatigue, increased white blood cell count, joint pain, diarrhea, difficulty breathing, edema, nausea, mucositis, prolonged QT interval on electrocardiogram, 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.

​LUCIVOS Lvosidenib Tablets 250mg Special groups

Hepatic Impairment: For patients with mild or moderate hepatic impairment (Child-Pugh A or B), no adjustment of the initial dose is needed. The pharmacokinetics and safety of Ivosidenib in patients with severe hepatic impairment (Child-Pugh C) are not clear. For patients with pre-existing severe hepatic impairment, the risks and potential benefits should be considered before starting Ivosidenib treatment.

Renal Impairment: For patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m², MDRD), no adjustment of the initial dose is necessary. The pharmacokinetics and safety of Ivosidenib in patients with severe renal impairment (eGFR < 30 mL/min/1.73m², MDRD) or those requiring dialysis are not clear. For patients with pre-existing severe renal impairment or requiring dialysis, the risks and potential benefits should be considered before starting Ivosidenib treatment.

Elderly Patients: Elderly patients do not require dose adjustments.

Children: There is currently no clinical study data available for the use of this drug in patients under 18 years of age.

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