Olutasidenib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Black Box Warning
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DIFFERENTIATION SYNDROME
See full prescribing information for complete Boxed Warning.
Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.
Withhold REZLIDHIA, if Differentiation Syndrome is suspected, initiate treatment with corticosteroid treatment and monitor the hemodynamic vitals until symptoms resolve.
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Overview
Olutasidenib is a isocitrate dehydrogenase-1 (IDH1) inhibitor that is FDA approved for the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, vomiting, diarrhea, constipation, abdominal pain, decreased appetite, mucositis, arthralgia, fatigue, pyrexia, edema, leukocytosis, differentiation syndrome, dyspnea, cough, rash, headache, hypertension, and transaminitis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- The recommended dosage of REZLIDHIA is 150 mg taken orally twice daily until disease progression or unacceptable toxicity.
- There should be more than 8-hour interval between two doses.
- REZLIDHIA should be administered on an empty stomach, at least 1 hour before or 2 hours after meal.
- The capsule should be swallowed as a whole without breaking, chewing or opening.
- if a dose is missed, it should be taken immediately with the next dose after 8 hours
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Olutasidenib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
none
Warnings
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DIFFERENTIATION SYNDROME
See full prescribing information for complete Boxed Warning.
Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.
Withhold REZLIDHIA, if Differentiation Syndrome is suspected, initiate treatment with corticosteroid treatment and monitor the hemodynamic vitals until symptoms resolve.
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- Differentiation Syndrome
- Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. **Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain.
- If the differentiation syndrome is suspected, REZLIDHIA should withhold temporarily and immediately start on corticosteroids for 3 day- dexamethasone 10 mg IV every 12 hours with continuous hemodynamic monitoring.
- Hydroxyurea may also be initiated if leukocytosis occurs.
- Taper corticosteroids and Hydroxyurea with resolution of symptoms.
- Hepatotoxicity
- REZLIDHIA may cause an increase in the alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin.
- This hepatoxicity may present as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
- Therefore always obtain baseline liver function tests before initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy.
- If the hepatic dysfunctions tend to continue, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence or severity.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Olutasidenib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Olutasidenib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Olutasidenib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Olutasidenib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Olutasidenib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Olutasidenib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Olutasidenib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Olutasidenib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Olutasidenib in geriatric settings.
Gender
There is no FDA guidance on the use of Olutasidenib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Olutasidenib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Olutasidenib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Olutasidenib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Olutasidenib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Olutasidenib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Olutasidenib Administration in the drug label.
Monitoring
There is limited information regarding Olutasidenib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Olutasidenib and IV administrations.
Overdosage
There is limited information regarding Olutasidenib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Olutasidenib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Olutasidenib Mechanism of Action in the drug label.
Structure
There is limited information regarding Olutasidenib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Olutasidenib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Olutasidenib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Olutasidenib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Olutasidenib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Olutasidenib How Supplied in the drug label.
Storage
There is limited information regarding Olutasidenib Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Olutasidenib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Olutasidenib interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Olutasidenib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Olutasidenib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.