Lucivos Lvosidenib Tablets ivosidenib、Tibsovo

[Product Name] Ivosidenib Tablets

[English Name] Ivosidenib Tablets

[Other Names] Ivosidenib / Tibsovo

[Specification] 250 mg × 60 tablets per box.

[Manufacturer] Lucius Pharmaceutical (Laos) Co., Ltd.

Ivosidenib (also known as LuciVos, Tibsovo) is an innovative medication used to treat specific types of Acute Myeloid Leukemia (AML). The emergence of this drug offers new hope to AML patients, particularly those for whom traditional chemotherapy has proven ineffective. In this article, we will explore in detail the usage and dosage of Ivosidenib, as well as how it helps patients combat this serious disease.

[Mechanism of Action of Ivosidenib]

Ivosidenib is an oral medication that exerts its therapeutic effect by targeting IDH1 mutations. IDH1 is an enzyme involved in normal cellular metabolic processes; however, in certain cancer cells, IDH1 undergoes mutations, which drives the growth and survival of these cancer cells. Ivosidenib works by inhibiting the activity of this mutated enzyme, thereby disrupting the metabolic abnormalities within the cancer cells and suppressing their proliferation.

[Indications for Ivosidenib]

Ivosidenib is primarily indicated for the treatment of adult patients with Acute Myeloid Leukemia (AML) harboring an IDH1 mutation. This includes newly diagnosed adult patients, as well as those who have undergone at least two prior therapies but whose disease has relapsed or remains refractory to treatment.

[Dosage and Administration]

Patient Selection

Prior to initiating treatment with Ivosidenib for adult patients with relapsed or refractory Acute Myeloid Leukemia (AML), it is mandatory to confirm the presence of an Isocitrate Dehydrogenase-1 (IDH1) mutation in the patient's bone marrow or peripheral blood. A fully validated diagnostic assay should be utilized to determine the patient's IDH1 mutation status. Patients confirmed to harbor an IDH1 mutation—based on test results from a hospital or laboratory—are eligible to receive treatment with Ivosidenib.

Recommended Dosage

The recommended dosage is 500 mg, taken orally once daily. The medication may be taken either on an empty stomach or after a meal, and treatment should be continued until disease progression occurs or until intolerable toxicity develops. Patients who do not experience disease progression or unacceptable toxicity should receive treatment for at least 6 months to allow for adequate assessment of clinical response.

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

Take the medication at the same time each day. If vomiting occurs after taking the dose, do not take a replacement dose. Resume the regular dosing schedule at the usual time the following day.

If a dose is missed or not taken at the scheduled time, take the missed dose as soon as possible (provided it is at least 12 hours before the next scheduled dose); however, if it is less than 12 hours until the next scheduled dose, do not take the missed dose, but instead resume the normal dosing schedule the following day. Do not take two doses within a 12-hour period.

Lactation: Women are advised not to breastfeed.

Monitoring for Toxicity

Monitor blood cell counts and blood chemistry prior to the first dose, at least once weekly during the first month of treatment, once every two weeks during the second month, and once monthly thereafter throughout the treatment period. Monitor blood creatine phosphokinase (CPK) levels once weekly during the first month of treatment. Perform an electrocardiogram (ECG) at least once weekly during the first three weeks of treatment, and at least once monthly thereafter throughout the treatment period. Any abnormal findings should be addressed promptly.

Dose Adjustment for Concomitant Use with Strong CYP3A4 Inhibitors

If concomitant use with a strong CYP3A4 inhibitor is unavoidable, reduce the dose of this product to 250 mg once daily. At least 5 half-lives after discontinuing the strong CYP3A4 inhibitor, the dose of this product may be restored to the recommended dose of 500 mg once daily.

[Use in Pregnant and Lactating Women]

Contraception

Female patients of reproductive potential, and male patients with female partners of reproductive potential, should use effective methods of contraception during treatment and for at least 1 month after the last dose. Concomitant use with this product may reduce the concentrations of hormonal contraceptives; therefore, patients receiving this product should use alternative methods of contraception during treatment and for at least 1 month after the last dose. Females of reproductive potential should undergo pregnancy testing prior to initiating treatment with this product. Pregnancy

Based on its mechanism of action, this product may cause fetal harm when administered to a pregnant woman. If this product is used during pregnancy, or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus.

Lactation

There are no data on the presence of this product 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 because of the potential for adverse reactions in breastfed infants, it is recommended that women discontinue breastfeeding during treatment with this product and for at least 1 month after the last dose.

Fertility

No animal or human fertility studies have been conducted with this product.

[Adverse Reactions]

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

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

[Special Populations]

Hepatic Impairment

No initial dose adjustment 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 (Child-Pugh C) hepatic impairment have not been established. For patients with pre-existing severe hepatic impairment, the risks and potential benefits should be considered prior to initiating treatment with Ivosidenib tablets.

Renal Impairment

No initial dose adjustment is required for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m², MDRD).

The pharmacokinetics and safety of Ivosidenib in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m², MDRD) or renal impairment requiring dialysis have not been established. For patients with pre-existing severe renal impairment or those requiring dialysis, the risks and potential benefits should be carefully considered prior to initiating treatment with Ivosidenib tablets.

Geriatric Patients

No dose adjustment is required for elderly patients.

Pediatric Patients

No clinical data are available regarding the use of this product in patients under 18 years of age.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).