Tibsovo

Description

Generic Name:
Ivosidenib

Description:
Tibsovo targets a specific gene mutation called IDH1, which can affect your bone marrow. IDH1 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in symptoms of acute myeloid leukemia (AML).

Tibsovo is for use only in adults with an IDH1 mutation. Your doctor will test you for this gene.

Tibsovo is used to treat AML after other treatments did not work or stopped working.

Tibsovo is used with or without azacitidine to treat newly-diagnosed AML in adults 75 years and older or who have health problems that prevent the use of certain chemotherapy treatments.

Tibsovo is also used to treat bile duct cancer (cholangiocarcinoma) that has progressed or has spread to other parts of the body (metastatic) after treatment with other medicine.

Indication:
IDH1 mutation, AML, bile duct cancer

Dosage:
Usual Adult Dose for Acute Myeloid Leukemia:

500 mg orally once daily until disease progression or unacceptable toxicity; for patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response

Comments:
-NOTE: Select patients for the treatment of AML based on the presence of IDH1 mutations in the blood or bone marrow. Patients without IDH1 mutations at diagnosis should be retested at relapse because a mutation in IDH1 may emerge during therapy and at relapse.

Use: For the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test

Usual Geriatric Dose for Acute Myeloid Leukemia:

75 years or older:
500 mg orally once daily until disease progression or unacceptable toxicity; for patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response

Comments:
-NOTE: Select patients for the treatment of AML based on the presence of IDH1 mutations in the blood or bone marrow. Patients without IDH1 mutations at diagnosis should be retested at relapse because a mutation in IDH1 may emerge during therapy and at relapse.

Use: in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy

Usual Adult Dose for Cholangiocarcinoma

500 mg orally once daily with or without food until disease progression or unacceptable toxicity

Use: For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.

Precaution & Warnings:
Tibsovo can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 3 months after you start taking Tibsovo.

Seek medical help right away if you have symptoms of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, rash, or decreased urination.

Prescription Information:
Proper doctor prescription is needed.
*Note: The prescription should not be older than 6 month.

Contraindication:
Tibsovo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may interact with ivosidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.