Tibsovo (ivosidenib) is a prescription medicine used for the treatment of adult patients with an isocitrate dehydrogenase-1 (IDH1) mutation with:
Acute myeloid leukemia (AML): newly diagnosed AML treated along with azacitidine or alone who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments or when the disease has come back or has not improved after previous treatment(s).
Myelodysplastic syndromes (MDS): when the disease has come back or has not improved after previous treatment(s).
Bile Duct Cancer (Cholangiocarcinoma): when cancer has spread and patients have already received previous treatment(s).
Here is some important safety information about Tibsovo:
Warnings and Precautions:
Differentiation Syndrome: This can occur as early as 1 day and up to 3 months after starting treatment with Tibsovo. Symptoms may include dyspnea, fever, pleural effusion, pulmonary infiltrates, and rapid weight gain. It can be managed with corticosteroids and hemodynamic monitoring.
QT Prolongation: Tibsovo can prolong the QT interval, increasing the risk of life-threatening arrhythmias. Monitoring with ECG and electrolytes is recommended.
Guillain-Barré Syndrome: Cases of Guillain-Barré Syndrome have been reported. Patients should be monitored for signs and symptoms like muscle weakness and tingling.
Hepatotoxicity: Liver function tests should be monitored before and during treatment. Adjustments to the dosage or discontinuation may be necessary if severe hepatotoxicity occurs.
Common Side Effects:
- Rash
- Fever
- Fatigue
- Leukocytosis (increase in white blood cells)
- Diarrhea
- Nausea
- Mucositis (inflammation of the mucous membranes)
- Arthralgia (joint pain)
- Electrolyte disturbance
Use in Specific Populations:
Pregnancy: Treatment with this therapeutic drug can cause fetal harm. Women of reproductive potential should use proper contraception throughout treatment and for some time after the final dose.
Lactation: Women should avoid breastfeeding during treatment and for at least one month after the last dose.
Pediatric Use: Safety as well as effectiveness have not been established in pediatric patients.
Geriatric Use: No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
Drug Interactions:
Tibsovo may interact with other medications that are substrates of CYP3A4. It may also affect drugs metabolized by other pathways.
Monitoring:
Regular monitoring of blood counts, liver function, and ECGs are recommended during treatment.
Note: Always consult with a healthcare provider for personalized medical advice before starting or stopping any medication.
Reference:
https://www.tibsovo.com/
