Ivonib IVOSIDENIB 250 MG 60 TABLETS Approval No. 07 L 1149/24 Expiry Date 28/7/2027

Ivosidenib (trade name: Ivonib) is a targeted therapy drug for specific gene mutations, mainly used to treat diseases such as acute myeloid leukemia (AML) caused by IDH1 gene mutations. The following is the detailed description of ivosidenib:

1. Name of the drug

• Generic Name : Ivosidenib
• Trade Name : Ivonib

2. Pharmacological Mechanism

• Ivosidenib is an IDH1 inhibitor . IDH1 gene mutations can lead to abnormal proliferation of tumor cells. Ivosidenib inhibits these mutated IDH1 enzymes, helping to restore normal cell metabolism and thus inhibit cancer cell growth.

3. Indications

• Acute Myeloid Leukemia (AML) : For the treatment of adult patients with acute myeloid leukemia who carry an IDH1 gene mutation.
• Other indications : Sometimes used for other types of IDH1 mutation-associated cancers, but primarily for AML.

4. Dosage and Administration

• Recommended dose : 500 mg per day (usually as two 250 mg tablets).
• Dosage : The drug should be taken orally. It can be taken with food or on an empty stomach, but it is recommended to take it at a fixed time every day to ensure the effectiveness of the drug.
• Dosage cycle : Ivosidenib is usually taken long-term until the disease progresses or intolerable side effects occur.
• Treatment for missed doses : If you forget to take a dose, you should take it as soon as possible, but if it is close to the next dose time, you should skip the missed dose and never take two doses at once.

5. Side Effects

Side effects of ivosidenib may include:

Common side effects :

• fatigue
• nausea
• Leukopenia (may cause decreased immune system function)
• diarrhea
• Decreased appetite

Serious side effects :

• Heart problems : QT interval prolongation may lead to irregular heartbeat, and electrocardiograms should be performed regularly during treatment.
• Abnormal liver function : Liver function monitoring is very important. If abnormal liver function occurs, the drug may need to be discontinued or the dosage adjusted.
• Leukopenia : May lead to an increased risk of infection and requires regular blood tests.

6. Contraindications

• Patients with hypersensitivity to ivosidenib or its ingredients are contraindicated.
• Pregnant and breastfeeding women should avoid using it as the drug may have adverse effects on the fetus or infant.

7. Drug Interactions

• Ivosidenib may interact with other medications, particularly those that affect cardiac conduction (e.g., antibiotics, antifungals, etc.) and those that may alter drug metabolism.
• Patients should tell their doctors about all medications they are taking, including over-the-counter and herbal medicines, while taking ivosidenib.

8. Storage

• Store at room temperature away from moisture and heat. Keep out of reach of children.
• Do not use this medicine if it is expired or appears unusual.

9. Notes

• Regular monitoring : When using ivosidenib, patients need to undergo regular blood tests, liver function tests, and electrocardiograms to detect possible side effects in a timely manner.
• Special populations : Patients with underlying diseases such as liver disease and heart disease need to be particularly careful when using the product and adjust the dosage under the guidance of a doctor.
• Pregnancy and breast-feeding : Ivosidenib may cause adverse effects on the fetus or infant, so pregnant and breast-feeding women should avoid using it.

10. Clinical research and effects

• Clinical studies have shown that ivosidenib is effective for patients with acute myeloid leukemia with IDH1 mutations and can help improve patients' survival rate and quality of life.

11. Conclusion

Ivosidenib is a targeted drug specifically for IDH1 gene mutations, mainly used to treat acute myeloid leukemia (AML). Patients must strictly follow the doctor's instructions when using this drug and regularly check relevant indicators to ensure the safety and effectiveness of the treatment. If serious side effects occur, communicate with the doctor in a timely manner to adjust the treatment plan.