How it Works

Olutasidenib is a targeted therapy that works by inhibiting the activity of a protein called mutant isocitrate dehydrogenase 1 (IDH1), which is frequently mutated in AML and plays a role in the development of the disease. By inhibiting IDH1, olutasidenib may help to kill AML cells and slow the progression of the disease.

How it’s Administered

Olutasidenib is usually taken as an oral tablet and is often used in combination with other chemotherapy medications.
Olutasidenib should be avoided in combination with strong or moderate CYP3A inducers, which are medications that can increase the activity of the CYP3A enzyme and potentially affect the metabolism of olutasidenib, or sensitive CYP3A substrates, which are medications that are metabolized by the CYP3A enzyme and may be affected by Olutasidenib. Some examples are: Carbamazepine, Phenytoin, Rifampin, statins (such as atorvastatin and simvastatin), immune modulators (such as tacrolimus and sirolimus), and antidepressants (such as fluoxetine and paroxetine).
Before starting treatment with Olutasidenib, it is important to consult with your doctor to ensure that the medication is safe and appropriate for you. This is particularly important if you are taking other medications, as Olutasidenib may interact with certain drugs and cause undesired side effects or reduced effectiveness.

Who Should Take Olutasidenib

Olutasidenib is a targeted therapy for the treatment of acute myeloid leukemia (AML) that is approved for use in adults with AML who have a specific type of IDH1 mutation and who have failed or have not responded to previous treatments (Relapsed/Refractory AML).This mutation is found in about 10-15% of people with AML and is associated with a poorer prognosis.

Who Shouldn’t Take Olutasidenib

Patients with a severe allergy to olutasidenib or its components.
Pediatric AML patients because there is not enough evidence about the safety for this population.
Olutasidenib is not recommended for patients with mild to moderate liver or kidney impairment.
Pregnant women. It is important to inform your healthcare provider if you are pregnant, or planning to become pregnant before starting treatment with olutasidenib.
Olutasidenib may also pass into breast milk, you should suspend breastfeeding when taking this medication.

The most common side effects of taking Olutasidenib include:

Inflammation of the liver (transaminitis) or increases in certain liver enzymes (aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase)
Decreases in potassium and sodium levels
Increases in bilirubin levels and uric acid levels
Nausea, constipation, diarrhea
Increased creatinine levels (kidney damage)
Fatigue or malaise
Joint pain (arthralgia)
Increases in certain white blood cells (lymphocytes, leukocytosis)
Shortness of breath (dyspnea)
Fever (pyrexia)
Rash
Increases in certain enzymes produced by the pancreas (lipase)
Inflammation of the lining of the mouth (mucositis)
Differentiation syndrome is a very serious side effect that is preventable with proper monitoring and immediate treatment. This syndrome is a reaction between the drug and leukemia, which produces fever, difficulty breathing, weight gain, lung and heart problems. It is generally treated with high-dose steroids. In most cases, the treatment will continue. The syndrome usually occurs during the first month of treatment, with some cases reported following the first dose.

Commonly Used in Acute Myeloid Leukemia With

Plus azacitidine.
As a standalone single-drug therapy.

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Date last updated: 12/22/22

Olutasidenib

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