Tibsovo (Ivosidenib)
Indications:
Tibsovo is a prescription medication used to treat adult patients with an IDH1 mutation in the following conditions:
- Acute Myeloid Leukemia (AML): For newly diagnosed AML, Tibsovo is used in combination with azacitidine or as monotherapy in patients 75 years or older, or those unable to receive intensive chemotherapy. It is also used when the disease has recurred or has not responded to prior treatments.
- Myelodysplastic Syndromes (MDS): For patients with MDS that has relapsed or not improved after previous treatments.
- Cholangiocarcinoma (Bile Duct Cancer): Used when the cancer has metastasized and patients have already undergone previous treatment.
Important Safety Information:
Warnings and Precautions:
Differentiation Syndrome: May occur from 1 day to 3 months after starting treatment. Symptoms include breathing difficulties, fever, pleural effusion, pulmonary infiltrates, and rapid weight gain. Managed with corticosteroids and close monitoring.
QT Prolongation: Tibsovo can prolong the QT interval, raising the risk of serious arrhythmias. Regular ECG and electrolyte monitoring are advised.
Guillain-Barré Syndrome: Reported cases include muscle weakness and tingling. Patients should be monitored for symptoms.
Hepatotoxicity: Liver function should be monitored before and during treatment. Dosage adjustments or discontinuation may be required for severe liver issues.
Common Side Effects:
- Rash
- Fever
- Fatigue
- Increased white blood cells (leukocytosis)
- Diarrhea
- Nausea
- Inflammation of the mucous membranes (mucositis)
- Joint pain (arthralgia)
- Electrolyte imbalances
Use in Specific Populations:
Pregnancy: Can cause fetal harm. Women of reproductive potential should use effective contraception during and after treatment.
Lactation: Avoid breastfeeding during treatment and for at least one month after the last dose.
Pediatric Use: Safety and efficacy have not been established in children.
Geriatric Use: No significant differences in safety or efficacy were observed between older and younger patients.
Drug Interactions:
Tibsovo may interact with medications metabolized by CYP3A4 and other pathways.
Monitoring:
Regular monitoring of blood counts, liver function, and ECGs is recommended during treatment.
Note: Always consult with a healthcare provider for personalized medical advice before starting or stopping any medication.
