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How it is administered
Olutasidenib is taken by mouth as a capsule. Each capsule contains 150 mg of olutasidenib. The recommended dose is 150 mg twice daily, taken about the same time each day. Swallow the capsules whole—do not break, open, or chew them.
It is important to take olutasidenib on an empty stomach, at least 1 hour before or 2 hours after a meal.
How it works
Olutasidenib is a targeted therapy that works by blocking the activity of a mutated enzyme called isocitrate dehydrogenase-1 (IDH1). In some patients with acute myeloid leukemia (AML), mutations in the IDH1 gene cause the enzyme to produce an abnormal substance called 2-hydroxyglutarate (2-HG). This substance can prevent normal blood cells from developing, contributing to the growth of leukemia cells.
By inhibiting the mutated IDH1 enzyme, olutasidenib reduces the levels of 2-HG. This allows leukemia cells to mature and die normally, helping to restore healthy blood cell production. Olutasidenib is specifically effective in patients whose AML has a susceptible IDH1 mutation, as confirmed by an FDA-approved test.
Common side effects
- Nausea
- Constipation
- Mucositis (mouth sores)
- Diarrhea
- Abdominal pain
- Vomiting
- Fatigue or malaise
- Fever (pyrexia)
- Edema (swelling)
- Joint pain (arthralgia)
- Rash
- Shortness of breath (dyspnea)
- Headache
- Decreased appetite
- High liver enzymes (transaminitis)
Laboratory abnormalities may include increased liver enzymes, decreased potassium or sodium, increased creatinine, increased bilirubin, increased uric acid, and increased lipase.
Serious side effects can include differentiation syndrome and liver toxicity.
Who Should take it
Olutasidenib is indicated for adult patients with acute myeloid leukemia (AML) that has relapsed or is refractory (has not responded to previous treatments) and who have a susceptible IDH1 mutation. This mutation must be detected by an FDA-approved test before starting therapy.
Patients who have already tried other treatments for AML and whose disease has returned or not responded may benefit from olutasidenib if their leukemia cells carry the IDH1 mutation.
Who should not take it
There are no absolute contraindications listed for olutasidenib. However, it should be used with caution in patients who may be pregnant, as it may cause harm to an unborn baby. Women should not breastfeed during treatment and for at least 2 weeks after the last dose.
Patients with severe liver or kidney impairment should discuss with their healthcare provider whether olutasidenib is appropriate, as its safety in these populations is not fully known.
Commonly used with
Olutasidenib is used as a single agent for relapsed or refractory AML with an IDH1 mutation. It is not indicated for use in combination with other chemotherapy agents for this specific indication.
In the clinical trial, some patients went on to receive stem cell transplantation after treatment with olutasidenib.
Commonly tested with
Olutasidenib is primarily tested as a single agent in patients with relapsed or refractory AML with an IDH1 mutation. In some studies, it has been combined with azacitidine, but this combination is not an approved use for olutasidenib in AML.
It is also tested alongside supportive care measures, such as hydroxyurea for leukocytosis and corticosteroids for differentiation syndrome, as needed.