- Medicine Name: Tibsovo
- Generic Name: Ivosidenib
- Dosage Form & Strength: Tablets: 250 mg
- Manufactured By: Servier Pharmaceuticals
Tibsovo is an isocitrate dehydrogenase-1 (IDH1) inhibitor used:
- in combination with medicine azacitidine or as monotherapy for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in adults aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
- for the treatment of adult individuals with relapsed/refractory Acute Myeloid Leukemia (AML).
- for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (bile duct cancer) who have been previously treated.
Note: Tibsovo 250 mg Tablet is used for patients with a susceptible IDH1 mutation as detected by an FDA-approved test.
Recommended Dosage: Select patients for the treatment of AML and Cholangiocarcinoma based on the presence of IDH1 mutations. Patients with AML without IDH1 mutations at diagnosis need to be retested at relapse because a mutation in IDH1 may occur during treatment and at relapse.
Newly Diagnosed AML (Combination Regimen): The recommended dosage is 500 mg taken by mouth once daily until the disease is progressive or unacceptable toxicity occurs. Start the administration of Tibsovo on Cycle-1 Day 1 along with medicine azacitidine 75 mg/m2 subcutaneously or intravenously once daily on Days 1’st to 7’th (or Days 1’st to 5’th & 8’th to 9’th) of each 28-day cycle.
For those without disease progression or unacceptable toxicity, continue ivosidenib 250 mg, along with medicine azacitidine, for a minimum of six months in order to allow time for clinical response.
Newly Diagnosed AML and Relapsed or Refractory AML (Monotherapy Regimen): The recommended dosage is 500 mg taken by mouth once daily until the disease is progressive or unacceptable toxicity occurs.
For those without disease progression or unacceptable toxicity, continue treatment for a minimum of six months in order to allow time for clinical response.
Cholangiocarcinoma: The recommended dosage is 500 mg taken by mouth once daily until the disease is progressive or unacceptable toxicity occurs.
Administer tibsovo tablet with or without food. Do not administer this medicine with a high-fat meal because it may increase the concentration of ivosidenib. Do not chew, split, or crush tablets. Administer it orally about the same time every day. If a dose is vomited, do not take a replacement dose; wait until the very next scheduled dose is due. If a dose is missed or not administered at the usual time, take the dose as quickly as possible and at least 12 hours before the next scheduled dose. Follow the standard schedule the following day. Do not administer a couple of doses within 12 hours.
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