Overview

- Introduction
- Benefits
- How it Works
- Dosage & Administration
- Side Effects
- Warning and Precaution
- Patient Guidance
- Clinical Trial & Approvals
- FAQ

Lucivos 250 mg Tablet

Q: Who is eligible for LuciVos treatment?

LuciVos is prescribed for adults with confirmed IDH1-mutant cancers, including: Acute Myeloid Leukemia (AML) – newly diagnosed or relapsed/refractory Cholangiocarcinoma (bile duct cancer) – with IDH1 mutation after prior treatment

Q: How should I take LuciVos?

Take 500 mg once daily, which is usually two 250 mg tablets, at the same time each day, with or without food. Swallow the tablets whole with water Do not crush or chew the tablets

Q: What if I miss a dose of LuciVos?

If you miss a dose: Take it as soon as you remember on the same day Do not take two doses the next day to make up for the missed one Skip the missed dose if it’s already the next day and continue with your regular schedule

Q: What are the common side effects of LuciVos?

Common side effects may include: Fatigue Nausea or vomiting Diarrhea or constipation Joint or muscle pain Changes in liver function tests

Q: Can LuciVos interact with other medications?

Yes. LuciVos (ivosidenib) may interact with: Strong CYP3A4 inhibitors or inducers (e.g., ketoconazole, rifampin) Drugs that prolong the QT interval (e.g., certain antibiotics or antipsychotics)Always inform your doctor about all medications and supplements you are taking.

Q: Can I drink alcohol while taking LuciVos?

It’s best to limit or avoid alcohol while on LuciVos, as it can strain the liver and increase the risk of side effects. Speak with your healthcare provider about alcohol use during treatment.

Prescription Required

Brand Name:

Lucivos

Molecule:

Ivosidenib

Strength:

250 mg

Quantity:

60 Tablets

Form:

Tablet

Packaging Type:

Bottle

Manufacturer/Marketed By:

Lucius Pharma

Country of Origin:

Laos

Categories: Oncology, Blood Cancer

Product	Manufacturer / Marketed By	Price
Tibsovo 250 mg Tablet	Servier	Ask for Price
Ivosenib 250 mg Tablet	Everest Pharma	Ask for Price

Description

LuciVos 500 mg Tablet is a once-daily, oral precision oncology treatment that contains ivosidenib, a first-in-class inhibitor of isocitrate dehydrogenase-1 (IDH1). This medication is specifically designed for patients with cancers harboring a susceptible IDH1 mutation, which plays a crucial role in promoting abnormal cell metabolism and inhibiting normal cell maturation. LuciVos directly targets the mutant IDH1 enzyme, which is found in various aggressive cancers, including acute myeloid leukemia (AML) and cholangiocarcinoma (also known as bile duct cancer). By correcting the underlying metabolic disturbance caused by this mutation, LuciVos helps to restore the natural process of cellular differentiation, transforming immature cancer cells into mature, functioning blood or tissue cells. This targeted approach makes LuciVos an integral part of personalized cancer therapy, offering both monotherapy and combination treatment options tailored to a patient's clinical profile.

Benefits

Molecular Precision

LuciVos selectively inhibits the mutant IDH1 enzyme, reducing levels of the harmful oncometabolite 2-hydroxyglutarate (2-HG).
This restores regular gene expression, enabling cancer cells to resume differentiation and helping reduce tumor burden without the need for broadly toxic chemotherapy.

Versatile Treatment Options

Approved for use as monotherapy in relapsed or refractory AML and in patients ineligible for intensive chemotherapy.
It can also be used in combination with azacitidine for the treatment of newly diagnosed AML, offering a flexible, less-intensive treatment pathway.

Oral, Once-Daily Dosing

Administered as a single oral tablet per day, LuciVos offers convenience, independence, and ease of use, which is especially important for elderly or outpatient cancer patients.
Supports home-based treatment, which can reduce hospital visits and improve long-term therapy adherence.

Clinically Proven Results

Demonstrated improved overall survival and remission rates in multiple clinical trials for AML.
The ClarIDHy trial also showed that LuciVos significantly improves progression-free survival in patients with previously treated IDH1-mutated cholangiocarcinoma.

How it Works

LuciVos (ivosidenib) is a targeted cancer therapy that works by inhibiting the activity of mutant isocitrate dehydrogenase-1 (IDH1), a genetic mutation found in several types of cancer, including acute myeloid leukemia (AML) and cholangiocarcinoma.

In its mutated form, IDH1 produces an abnormal metabolite called 2-hydroxyglutarate (2-HG). Excessive 2-HG disrupts normal cellular functions by:

Blocking gene expression pathways that are necessary for healthy cell differentiation.
Promoting an environment where immature cells remain “stuck” in a cancerous, proliferative state.

LuciVos Restores Normal Cell Function by:

Inhibiting mutant IDH1 activity, thereby reducing the buildup of 2-HG.
Reactivating normal cellular maturation, allowing cancer cells to develop into healthy, non-proliferative cells.
Enabling the body’s natural mechanisms to control or eliminate cancerous cells is a therapeutic strategy known as differentiation therapy.

This mode of action differs from traditional chemotherapy, as it corrects the underlying cause of disease without broadly killing rapidly dividing cells, thereby reducing systemic toxicity.

Dosage & Administration

LuciVos should be prescribed and supervised by a healthcare provider with experience in treating cancers associated with IDH1 mutations. Genetic testing is required before initiating treatment.

For Newly Diagnosed AML (Ineligible for Intensive Chemotherapy)

Combination Regimen with Azacitidine:

LuciVos Dose: 500 mg orally once daily (two 250 mg tablets), starting Cycle 1, Day 1.
Azacitidine Dose: 75 mg/m² subcutaneously or intravenously:
- Administered on Days 1–7 of each 28-day cycle
- Alternate dosing schedule: Days 1–5 and 8–9, as clinically appropriate

Duration:

Continue both LuciVos and azacitidine for a minimum of 6 months, even in the absence of immediate clinical improvement.
Treatment should continue until disease progression or the development of unacceptable side effects.

Monotherapy Regimen

Applicable for:

Newly diagnosed AML patients not receiving combination therapy
Relapsed or refractory AML patients who have received prior treatment
Dose: 500 mg orally once daily
Administration: With or without food; take at the same time each day
Duration: Continue treatment as long as clinical benefit is observed and no intolerable toxicity occurs

Side Effects

Like all targeted cancer therapies, LuciVos (ivosidenib) may cause side effects. While many are manageable, some may be serious and require immediate medical attention.

Common Side Effects (≥10% of patients)

These effects are typically mild to moderate and may improve over time or with supportive care:

Fatigue – General tiredness or lack of energy
Nausea – Occasional stomach upset
Diarrhea or Constipation – Digestive irregularities
Cough – Usually dry and non-productive

These symptoms should be reported if they persist or interfere with daily activities.

Serious Side Effects (<10% of patients)

These are less common but potentially life-threatening. Early detection and management are critical:

Differentiation Syndrome

Caused by the rapid maturation of cancer cells
Symptoms: Fever, shortness of breath, rapid weight gain, fluid retention, low blood pressure
Treatment: Requires immediate corticosteroid therapy and possible interruption of LuciVos

QT Interval Prolongation

A change in heart rhythm that can lead to arrhythmia
Symptoms: Dizziness, fainting, palpitations
Monitoring: Regular electrocardiograms (ECGs) are required

Electrolyte and Liver Abnormalities

LuciVos can lower blood levels of potassium and magnesium, and increase liver enzymes (AST, ALT)
Monitoring: Frequent blood tests are essential for early detection and dose adjustment
Always report unusual or persistent side effects to your healthcare provider promptly.

Warning and Precaution

To ensure safe and effective treatment with LuciVos (ivosidenib), patients and healthcare providers should adhere to the following precautions:

Genetic Requirement

Mandatory IDH1 Mutation Testing: LuciVos is effective only in cancers driven by a mutant IDH1 gene. A validated diagnostic test must confirm this mutation before initiating therapy.

Monitoring Requirements

Electrocardiograms (ECG):
- Perform at baseline, on Days 8 and 15 of Cycle 1, and periodically throughout treatment to monitor for QT interval prolongation, which may signal heart rhythm abnormalities.
Laboratory Monitoring:
- Regular blood tests are necessary to evaluate electrolyte balance (including potassium, magnesium, and calcium), liver function (as indicated by AST, ALT, and bilirubin levels), and complete blood counts (CBC).
- Adjustments to treatment may be needed based on results.

Drug Interactions

Avoid using potent CYP3A4 inhibitors or inducers, such as:
- Inhibitors: Itraconazole, clarithromycin
- Inducers: Rifampin, phenytoin
These can significantly alter ivosidenib levels, increasing toxicity risk or reducing effectiveness.
Always inform your healthcare provider of all medications, supplements, or herbal products you are taking.

Pregnancy & Breastfeeding

Pregnancy Warning: LuciVos may harm an unborn baby. Use effective contraception during therapy and for at least 1 month after the final dose.
Breastfeeding: Avoid during treatment and for at least 1 week after stopping due to the potential for drug transfer through breast milk.

Patient Guidance

Proper storage ensures the safety and effectiveness of LuciVos:

Store at 20°C to 25°C (68°F to 77°F) in a cool, dry place. Avoid excessive heat and humidity.
Keep tablets in their original container with the desiccant packet. Do not transfer to other containers.
Do not use tablets that are broken, chipped, or discolored.
Do not flush unused tablets. Use a pharmacy take-back program or follow your pharmacist’s instructions for safe disposal.
Keep out of reach of children and pets.
Never share your medication, even with someone who has similar symptoms.

Clinical Trial & Approvals

Ivosidenib has been rigorously studied and approved based on key clinical trial data:

Acute Myeloid Leukemia (AML)

FDA Approval (2018): For relapsed or refractory IDH1-mutant AML
FDA Expansion (2019): For newly diagnosed AML patients ineligible for intensive chemotherapy, in combination with azacitidine
Evidence: AGILE and earlier studies demonstrated improved remission rates, overall survival, and tolerability in elderly and frail patients

Cholangiocarcinoma

FDA Approval (2021): For previously treated, IDH1-mutant locally advanced or metastatic cholangiocarcinoma
Evidence: The ClarIDHy Phase 3 trial showed significantly better progression-free survival and a favorable trend in overall survival versus placebo