Source: FDA, National Drug Code (US) Revision Year: 2020
IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Select patients for the treatment of AML with IDHIFA based on the presence of IDH2 mutations in the blood or bone marrow [see Indications and Usage (1.1) and Clinical Studies (14.1)].
The recommended starting dose of IDHIFA is 100 mg taken orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.
Do not split or crush IDHIFA tablets. Administer IDHIFA tablets orally about the same time each day. If a dose of IDHIFA is vomited, missed, or not taken at the usual time, administer the dose as soon as possible on the same day, and return to the normal schedule the following day.
Assess blood counts and blood chemistries for leukocytosis and tumor lysis syndrome prior to the initiation of IDHIFA and monitor at a minimum of every 2 weeks for at least the first 3 months during treatment. Manage any abnormalities promptly [see Adverse Reactions (6.1)].
Interrupt dosing or reduce dose for toxicities. See Table 1 for dosage modification guidelines.
Table 1: Dosage Modifications for IDHIFA-Related Toxicities
| Adverse Reaction | Recommended Action |
|---|---|
| Differentiation syndrome | • If differentiation syndrome is suspected, administer systemic corticosteroids and initiate hemodynamic monitoring [see Warnings and Precautions (5.1)]. • Interrupt IDHIFA if severe pulmonary symptoms requiring intubation or ventilator support, and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids [see Warnings and Precautions (5.1)]. • Resume IDHIFA when signs and symptoms improve to Grade 2* or lower. |
| Noninfectious leukocytosis (white blood cell [WBC] count greater than 30 × 109/L) | • Initiate treatment with hydroxyurea, as per standard institutional practices. • Interrupt IDHIFA if leukocytosis is not improved with hydroxyurea, and then resume IDHIFA at 100 mg daily when WBC is less than 30 × 109/L. |
| Elevation of bilirubin greater than 3 times the upper limit of normal (ULN) sustained for ≥2 weeks without elevated transaminases or other hepatic disorders | • Reduce IDHIFA dose to 50 mg daily. • Resume IDHIFA at 100 mg daily if bilirubin elevation resolves to less than 2 x ULN. |
| Other Grade 3* or higher toxicity considered related to treatment including tumor lysis syndrome | • Interrupt IDHIFA until toxicity resolves to Grade 2* or lower. • Resume IDHIFA at 50 mg daily; may increase to 100 mg daily if toxicities resolve to Grade 1* or lower. • If Grade 3* or higher toxicity recurs, discontinue IDHIFA. |
* Grade 1 is mild, Grade 2 is moderate, Grade 3 is serious, Grade 4 is life-threatening.
Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed. Store in the original bottle (with a desiccant canister) to protect from moisture.
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