olutasidenib

Pronunciation: oh LOO ta SID e nib

Brand: Rezlidhia

What is the most important information I should know about olutasidenib?

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.

What is olutasidenib?

Olutasidenib is used to treat acute myeloid leukemia (AML) in adults with a specific gene mutation called isocitrate dehydrogenase-1 (IDH1).

Olutasidenib is given after other treatments did not work or stopped working.

Your doctor will perform tests to make sure olutasidenib is the right treatment for you.

Olutasidenib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking olutasidenib?

Tell your doctor if you have ever had:

  • liver problems.

Olutasidenib may harm an unborn baby. Tell your doctor if you are pregnant.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

How should I take olutasidenib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take olutasidenib twice a day (12 hours apart) around the same time every day.

Take on an empty stomach, at least 1 hour before or 2 hours after a meal.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you vomit shortly after taking olutasidenib, do not take another dose. Take your next dose as scheduled.

You will need medical tests before and during treatment with olutasidenib.

Your treatment may be changed or permanently discontinued if you have certain side effects.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 8 hours. Do not use two doses within 8 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking olutasidenib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of olutasidenib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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.

Call your doctor at once if you have:

  • nausea, constipation, diarrhea, vomiting, stomach pain or mouth sores; or
  • liver problems --loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • abnormal blood tests;
  • nausea, diarrhea, constipation, mouth sores;
  • joint pain;
  • rash;
  • shortness of breath; or
  • tiredness, not feeling well, fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect olutasidenib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

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

Where can I get more information?

Your doctor or pharmacist can provide more information about olutasidenib.

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