Olutasidenib (Oral)

Generic name: olutasidenib [ oh-loo-ta-SID-e-nib ]
Brand name: Rezlidhia
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Jul 22, 2024.

Oral route(Capsule)

Warning: Differentiation Syndrome

Differentiation 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

Uses for olutasidenib

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 olutasidenib

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.

Pediatric

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.

Geriatric

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.

Interactions with 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

Interactions with Food/Tobacco/Alcohol

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 olutasidenib

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 olutasidenib

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 olutasidenib

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