Important Precautions for Ivosidenib Use

Ivosidenib is available only with a doctor's prescription.

Important Precautions for Ivosidenib Use

If you experience any changes in heart rhythm, contact your doctor immediately. You may feel dizzy or faint, or have a rapid, pounding, or irregular heartbeat. Be sure to tell your doctor if you have a history of heart rhythm problems, including QT prolongation.

Seek immediate medical attention if you develop symptoms such as fever, rash, joint pain, sudden numbness or weakness in the limbs, or inability to move the limbs. These may be signs of autoimmune syndrome, a condition in which the body’s immune system mistakenly attacks its own tissues.

Do not take any other medications unless discussed in advance with your doctor. This includes prescription drugs, over-the-counter (OTC) medicines, herbal remedies, or vitamin supplements.

Advantages of Ivosidenib

Clinical trial evidence shows that treatment with Tibsovo® (the brand name of ivosidenib) in combination with azacitidine improves overall survival in more patients compared with placebo plus azacitidine.

Tibsovo combined with azacitidine addresses unmet patient needs by helping control the disease, extending survival, and providing an additional treatment option.

However, based on our evaluation of health economic evidence, Tibsovo plus azacitidine does not demonstrate favorable cost-effectiveness for the healthcare system at its publicly listed price. The expert committee concluded that there is insufficient evidence to support that Tibsovo plus azacitidine offers greater cost-justification than venetoclax plus azacitidine.

Based on the listed price, Tibsovo is projected to generate approximately CAD 21 million in expenditures for public drug programs over the next three years. The actual budget impact will depend on the proportion of patients harboring the IDH1 R132 mutation.

Prior to initiating treatment with Tibsovo plus azacitidine, patients must be confirmed to have the IDH1 R132 mutation through next-generation sequencing (NGS) or polymerase chain reaction (PCR) testing. Currently, this testing is not part of the routine diagnostic workflow for acute myeloid leukemia (AML) across Canadian regions. The implementation of IDH1 R132 mutation testing may impose a significant impact on the healthcare system.

Additional Information on Ivosidenib

1. What is AML?

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow characterized by a reduction in the number of mature blood cells. It is one of the most aggressive forms of leukemia and is typically associated with a poor prognosis. It is estimated that the 1-year and 5-year survival rates after initial diagnosis are approximately 42% and 20%, respectively. Furthermore, 40% to 50% of newly diagnosed AML patients are ineligible for intensive induction chemotherapy. In 2022, there were approximately 1,600 new cases of AML in Canada.

2. Unmet Treatment Needs in AML

There is an urgent need for treatment regimens that can prolong survival, reduce transfusion requirements, alleviate symptoms, and improve patients’ quality of life.