Pronunciation:

oh-loo-ta-SID-e-nib

Brand Names:

• Rezlidhia

Dosage Forms:

• Capsule

Warnings:

Warning: Differentiation SyndromeDifferentiation syndrome, which can be fatal, can occur with olutasidenib treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.If differentiation syndrome is suspected, withhold olutasidenib and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Olutasidenib is used to treat acute myeloid leukemia in patients with a susceptible isocitrate dehydrogenase-1 (IDH-1) mutation that has come back or has not improved after previous treatments. Your doctor will test for the presence of this mutation.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of olutasidenib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olutasidenib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acalabrutinib
• Alfentanil
• Apalutamide
• Aprepitant
• Avanafil
• Avapritinib
• Bosentan
• Bosutinib
• Budesonide
• Buspirone
• Carbamazepine
• Cenobamate
• Cobimetinib
• Conivaptan
• Darifenacin
• Darunavir
• Dasatinib
• Dronedarone
• Efavirenz
• Eletriptan
• Entrectinib
• Enzalutamide
• Eplerenone
• Etravirine
• Everolimus
• Felodipine
• Finerenone
• Fluticasone
• Fosaprepitant
• Fosphenytoin
• Ibrexafungerp
• Ibrutinib
• Indinavir
• Ivabradine
• Ivacaftor
• Lomitapide
• Lorlatinib
• Lovastatin
• Lumacaftor
• Lurasidone
• Maraviroc
• Midazolam
• Mitotane
• Modafinil
• Nafcillin
• Naloxegol
• Phenobarbital
• Phenytoin
• Primidone
• Quetiapine
• Rifabutin
• Rifampin
• Sildenafil
• Simvastatin
• Sirolimus
• St John's Wort
• Temsirolimus
• Ticagrelor
• Tipranavir
• Tolvaptan
• Triazolam
• Ubrogepant
• Vardenafil
• Venetoclax
• Voclosporin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine on an empty stomach, at least 1 hour before or 2 hours after a meal. Take this medicine at the same time each day.

Swallow the capsule whole. Do not break, open, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For acute myeloid leukemia:
    • Adults—150 milligrams (mg) 2 times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 8 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. If you miss a dose and it is 8 hours or more until your next dose, take the missed dose then go back to your regular schedule. Do not take 2 doses within 8 hours.

If you vomit after taking a dose of this medicine, do not take an additional dose. Take the next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine may increase your risk of having a condition called differentiation syndrome, which may be life-threatening. It may occur as early as 1 day and up to 18 months after starting this medicine. Check with your doctor right away if you start to have a chills, cough, dizziness or lightheadedness, eye pain, fever, general feeling of illness, headache, rapid weight gain, sore throat, swelling in the arms or legs, trouble breathing, unusual tiredness. Your doctor may give you a steroid medicine (eg, dexamethasone) to help treat these symptoms.

Check with your doctor right away if you have dark urine, fatigue, loss of appetite, nausea or vomiting, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Agitation

bloody stools

blue lips, fingernails, or skin

blurred vision

chest pain or tightness

chills

coma

confusion

cough

decreased urine output

depression

dizziness

eye pain

fever

general feeling of illness

headache

hostility

irregular, fast or slow, or shallow breathing

irritability

lethargy

muscle twitching

nausea

pounding in the ears

rapid weight gain

rectal bleeding

seizures

slow or fast heartbeat

sore throat

stomach pain or tenderness

stupor

swelling of the face, ankles, or hands

trouble breathing

unusual tiredness or weakness

Incidence not known

Dark urine

loss of appetite

stomach pain, sever

vomiting

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding gums

body aches or pain

bone pain

constipation

diarrhea

difficulty in moving

hoarseness

irritation in the mouth

joint pain

mouth ulcers

muscle pain or stiffness

pain in the arms or legs

redness and swelling of the gums

stuffy or runny nose

tender, swollen glands in the neck

trouble in swallowing

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.