WARNING

Differentiation syndrome is a collection of symptoms that olutasidenib can produce that are significant or even fatal. In order to determine whether this syndrome is developing in you, your doctor will closely observe you. Please see your physician right away if you suffer any of the following symptoms: fever, cough, rash, unexpected weight gain, decreased urine, arm or leg swelling, fainting or lightheadedness, shortness of breath, or trouble breathing. After beginning olutasidenib therapy, these symptoms may appear up to 18 months later.

Your doctor may advise you to temporarily stop taking olutasidenib if differentiation syndrome symptoms appear at the first sign. Your doctor will also prescribe medication to treat the syndrome at this point. Do not miss any of your doctor’s or lab appointments. To monitor your body’s response to olutasidenib, your doctor will have you undergo a number of tests both before and after your therapy.

When you start olutasidenib therapy and each time you get a prescription refill, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, thoroughly read the material, then consult your physician or pharmacist.

Why is this medication prescribed?

Olutasidenib is used to treat a certain kind of acute myeloid leukemia (AML; a disease that starts in the white blood cells) that has returned or that has not improved following prior treatment(s). Olutasidenib belongs to a group of drugs known as IDH1 inhibitors. The proliferation of cancer cells is slowed or stopped by it.

How should this medicine be used?

An oral capsule containing olutasidenib is available. Typically, it is taken twice daily, at least 8 hours apart. It is recommended to take olutasidenib either one hour before or two hours after eating. Whenever possible, take olutasidenib at the same time each day. If there is anything you do not understand about the instructions on your prescription label, contact your doctor or pharmacist to clarify it. Olutasidenib should only be taken as prescribed. Take it only as directed by your doctor, neither more nor less than that amount or more frequently.

Avoid splitting, chewing, or crushing the capsules; simply swallow them whole.

Depending on how you respond to the drug or any side effects you experience, your doctor may lower your dose or temporarily or permanently cease your olutasidenib medication. How you are feeling while undergoing therapy should be discussed with your doctor. Without consulting your doctor beforehand, do not discontinue taking olutasidenib.

Other uses for this medicine

Inquire with your doctor or pharmacist for more details if you believe this drug may be prescribed for other purposes.

What special precautions should I follow?

Regarding special precautions, here are some important points to consider when using Olutasidenib:

• If you have any allergies, including to any of the substances in olutasidenib capsules, other drugs, or food, notify your doctor right away. For a list of the ingredients, consult your pharmacist or the Medication Guide.
• Inform your physician and pharmacist of all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are currently taking or intend to use while taking olutasidenib. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
• Olutasidenib may interact with the following over-the-counter medicines or herbal remedies: Saint John’s Wort. Prior to beginning olutasidenib therapy, be sure to inform your physician and pharmacist that you are taking this medicine. Without first consulting your healthcare professional, do not begin taking this herbal medication while also taking olutasidenib.
• Inform your physician if you now have or have ever had renal or liver illness.
• If you are expecting a child, intend to get pregnant, or are a nursing mother, let your doctor know. Call your physician if you conceive while taking olutasidenib.

These precautions are not exhaustive, and it’s important to consult with your healthcare professional or eye care specialist for comprehensive information and guidance specific to your individual circumstances.

What special dietary instructions should I follow?

Keep eating the same way as usual unless your doctor instructs you otherwise.

What should I do if I forget a dose?

When you recall, immediately take the missed dose. The missed dose should not be taken, and your regular dosing plan should continue if it is more than 8 hours until the following dose. If you miss a dose, don’t take a second one to make up for it. After taking a dose, if you throw up, take the following dose as scheduled and skip the previous one.

What side effects can this medication cause?

Possible negative effects of olutasidenib. Any of these symptoms that are severe or do not go away should be discussed with your doctor:

• Feeling queasy or sick
• Having fatigue or being ill
• Diarrhea or indigestion
• Joint discomfort
• Coughing or having trouble breathing
• Fever
• Inflammation or rash
• Gum disease or throat or mouth pain

There are several negative effects that can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those in the IMPORTANT WARNING section:

• Yellowing of the skin or eyes, black urine, appetite loss, abdominal pain, and extreme exhaustion

Other negative effects of olutasidenib could occur. If you have any strange side effects while taking this medicine, call your doctor right away.

What should I know about storage and disposal of this medication?

Storage and disposal:

Store this medication out of children’s reach in the tightly closed, original container. It should not be kept in the bathroom. Store it at room temperature, away from sources of extreme heat and moisture.

All medications should be kept out of the sight and reach of children, as many containers (such as weekly pill containers and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for toddlers to open. Always lock safety caps and put the medication in a secure spot right away that is up and away from where young children can access it and cannot access it, in order to prevent poisoning in young children.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city.

In case of emergency/overdose

Dial 1-800-222-1222 to reach the poison control hotline in the event of an overdose. Call 911 right away if the person has fallen, experienced a seizure, is having problems breathing, or cannot be roused.

What other information should I know?

Do not miss any of your doctor’s or lab appointments. To assess your body’s reaction to olutasidenib, your doctor will request a number of lab tests.

Make sure only you take your medication. Regarding prescription refills, ask your pharmacist any questions you may have.

It’s crucial that you keep a written record of every medication you take, including any vitamins, minerals, or other dietary supplements. This list should also include any over-the-counter (OTC) medications you use. When you visit a doctor or are admitted to the hospital, you should always bring this list with you. In case of crises, it is also crucial to have this information on hand.