Rezlidhia Dosage

Generic name: OLUTASIDENIB 150mg
Dosage form: capsule
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Mar 29, 2023.

Patient Selection

Select patients for the treatment of relapsed or refractory AML with REZLIDHIA based on the presence of IDH1 mutations in blood or bone marrow [see Clinical Trials (14.1)]. Information on FDA- approved tests for the detection of IDH1 mutations in AML is available at http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

The recommended dosage of REZLIDHIA is 150 mg taken orally twice daily until disease progression or unacceptable toxicity. Administer REZLIDHIA capsules orally about the same time each day. Do not administer 2 doses within 8 hours. Take on an empty stomach at least 1 hour before or 2 hours after a meal [see Clinical Pharmacology (12.3)]. For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.

Swallow REZLIDHIA capsules whole. Do not break, open, or chew the capsules. If a dose of REZLIDHIA is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of REZLIDHIA is missed or not taken at the usual time, administer the dose as soon as possible and at least 8 hours prior to the next scheduled dose. Return to the normal schedule the following day.

Monitoring and Dosage Modifications for Adverse Reactions

Assess blood counts, and blood chemistries including liver function tests prior to 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. Manage any abnormalities promptly [see Warnings and Precautions (5.1 and 5.2) and Adverse Reactions (6.1)].

Interrupt dosing or reduce dose for toxicities. See Table 1 for dosage modification guidelines.

Table 1: Recommended Dosage Modifications for REZLIDHIA
* Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening. Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).
Adverse Reactions	Recommended Action
Differentiation Syndrome [see Warnings and Precautions (5.1)]	If differentiation syndrome is suspected, withhold REZLIDHIA until signs and symptoms improve. Administer systemic corticosteroids and initiate hemodynamic monitoring until symptom resolution and for a minimum of 3 days. Resume REZLIDHIA at 150 mg twice daily after resolution of differentiation syndrome. If a recurrence of differentiation syndrome is suspected, withhold REZLIDHIA and institute treatment per above guidance. After resolution of symptoms, REZLIDHIA may be resumed at a reduced dose of 150 mg once daily for a minimum of 7 days, after which it can be increased to 150 mg twice daily.
Noninfectious leukocytosis [see Adverse Reactions (6.1)]	Initiate treatment with hydroxyurea, as per standard practices. Taper hydroxyurea only after leukocytosis improves or resolves.
Grade 3* hepatotoxicity [see Warnings and Precautions (5.2)]	Withhold REZLIDHIA and monitor liver function tests, twice per week, until laboratory values have returned to baseline or Grade 1* toxicity. Resume REZLIDHIA at a reduced dose of 150 mg once daily and continue monitoring; may increase to 150 mg twice daily if hepatotoxicity resolves to baseline for at least 28 days. If hepatotoxicity (Grade 3) recurs at 150 mg once daily, discontinue REZLIDHIA.
Grade 4* hepatotoxicity or AST or ALT >3x ULN and total bilirubin >2x ULN and alkaline phosphatase <2x ULN in the absence of a clear alternative explanation [see Warnings and Precautions (5.2)]	Permanently discontinue REZLIDHIA
Other Grade 3* or higher toxicity considered related to treatment [see Adverse Reactions (6.1)]	Interrupt REZLIDHIA until toxicity resolves to Grade 2* or lower. Resume REZLIDHIA at 150 mg once daily; may increase to 150 mg twice daily if toxicities resolve to Grade 1* or lower for at least 1 week. If Grade 3* or higher toxicity recurs at 150 mg once daily, discontinue REZLIDHIA.