TIBSOVO 250 MG TAB (IVOSIDENIB)

What is Tibsovo?

Tibsovo (ivosidenib) is a once-daily oral medication that targets a specific gene mutation called the isocitrate dehydrogenase-1 (IDH1) mutation, which can affect your bone marrow. An IDH1 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in blood and bone marrow disorders such as acute myeloid leukemia (AML).

Tibsovo may be used to treat adults with a confirmed susceptible IDH1 mutation with:

• newly diagnosed acute myeloid leukemia (AML) either in combination with azacitidine or as monotherapy in patients 75 years or older who have comorbidities that preclude the use of intensive induction chemotherapy
• relapsed or refractory AML
• relapsed or refractory myelodysplastic syndromes
• bile duct cancer (cholangiocarcinoma) that has progressed or has spread to other parts of the body (metastatic) after treatment with other medicine.

🧬 Introduction

Ivosidenib (brand name: Tibsovo®) is an oral targeted anticancer medication developed to treat cancers with a specific genetic mutation in the IDH1 (isocitrate dehydrogenase 1) gene. This mutation leads to abnormal cell growth. Ivosidenib is the first-in-class IDH1 inhibitor, and it provides a precision treatment option in acute myeloid leukemia (AML) and cholangiocarcinoma (bile duct cancer).

💊 Salt/Composition

• Generic Name: Ivosidenib

• Brand Name: Tibsovo

• Form: Tablet

• Strength: 250 mg

• Manufacturer in India: Servier India (via global parent Servier Pharmaceuticals)

📋 Uses / Indications

Ivosidenib is used in patients who test positive for IDH1 mutation for the following:

1. Relapsed or refractory Acute Myeloid Leukemia (AML)

2. Newly diagnosed AML in adults who are 75 years or older or have comorbidities that preclude intensive chemotherapy

3. Cholangiocarcinoma (bile duct cancer) that is locally advanced or metastatic and has been treated with at least one previous line of therapy

🧪 Dosage and Administration

• Standard Dose:
  250 mg orally once daily

• Duration:
  Continue until disease progression or unacceptable toxicity.

• Administration:

  • Can be taken with or without food

  • Do not crush, chew, or split the tablet.

  • Swallow whole with water.

⚠️ Side Effects

Common side effects:

• Nausea

• Diarrhea or constipation

• Fatigue

• Increased liver enzymes (AST/ALT)

• Shortness of breath

• Joint pain

• Prolonged QT interval (heart rhythm change)

• Low potassium or magnesium

• White blood cell differentiation syndrome

Serious side effects:

• Differentiation Syndrome (can be fatal if not treated promptly)

• Heart rhythm problems (QT prolongation)

• Liver injury

• Tumor lysis syndrome

⚠️ Precautions & Warnings

1. IDH1 Mutation Test Required:
   Use only in patients with confirmed IDH1 mutation.

2. Avoid in Pregnancy and Breastfeeding:

   • May cause fetal harm

   • Use effective contraception during treatment and for 1 month after the last dose

3. QT Prolongation:

   • Monitor ECG and electrolytes regularly

   • Avoid combining with drugs that also prolong QT

4. Liver Function Monitoring:

   • Regular LFTs (Liver Function Tests) are recommended

5. Avoid Grapefruit Juice:

   • May increase drug levels and side effects

6. Differentiation Syndrome:

   • Can appear within the first 3 months

   • Symptoms: fever, cough, low blood pressure, rapid weight gain, breathing difficulty

   • Requires urgent corticosteroid treatment

✅ Conclusion

Ivosidenib (Tibsovo) is a breakthrough targeted therapy for cancers with the IDH1 mutation. It represents a significant step forward for precision oncology, especially for patients with limited options.
Regular monitoring, genetic testing, and specialist supervision are essential for safe and effective use of this medicine.