IDENTIFY & MONITOR

In the clinical trial,

OTHER ARs REPORTED IN ≥10% (ANY GRADE) OR ≥3% (GRADES 3-5) OF PATIENTS WITH R/R AML

Body Systems AR	All grades N=214 (%)	≥Grade 3 N=214 (%)
Gastrointestinal disorders^a
Nausea	107 (50)	11 (5)
Diarrhea	91 (43)	17 (8)
Vomiting	73 (34)	4 (2)
Metabolism and nutrition disorders
Decreased appetite	73 (34)	9 (4)
Tumor lysis syndrome (TLS)^b	13 (6)	12 (6)
Nervous system disorders
Dysgeusia	25 (12)	0 (0)

^aGastrointestinal disorders observed with IDHIFA® treatment can be associated with other commonly reported events, such as abdominal pain and weight decrease.

^bTLS observed with IDHIFA® treatment can be associated with commonly reported uric acid increase.

ADDITIONAL ANALYSIS: FREQUENCY OF ADVERSE REACTIONS OVER TIME¹

In addition to the ARs reported above, blood and lymphatic system disorders have been reported, including differentiation syndrome and noninfectious leukocytosis.

Download our IDHIFA® wallet cards, printable cards for patients and caregivers to show to their non-regular healthcare providers. These printable resources also include information about differentiation syndrome and other ARs associated with IDHIFA®.

IDHIFA® Wallet Cards

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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, and Grade 4 is life-threatening.

IDHIFA® Wallet Cards

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Indication

IDHIFA® (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

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Important Safety Information

WARNING: DIFFERENTIATION SYNDROME

Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

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WARNINGS AND PRECAUTIONS

Differentiation Syndrome: See Boxed WARNING. In the clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, in as early as 1 day and up to 5 months after IDHIFA initiation. Symptoms in patients treated with IDHIFA included acute respiratory distress represented by dyspnea and/or hypoxia and need for supplemental oxygen; pulmonary infiltrates and pleural effusion; renal impairment; fever; lymphadenopathy; bone pain; peripheral edema with rapid weight gain; and pericardial effusion. Hepatic, renal, and multi-organ dysfunction have also been observed. If differentiation syndrome is suspected, initiate systemic corticosteroids and hemodynamic monitoring until improvement. Taper corticosteroids only after resolution of symptoms. Differentiation syndrome symptoms may recur with premature discontinuation of corticosteroids. If severe pulmonary symptoms requiring intubation or ventilator support and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids, interrupt IDHIFA until signs and symptoms are no longer severe. Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended.

Embryo-Fetal Toxicity: Based on animal embryo-fetal toxicity studies, IDHIFA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with IDHIFA and for at least 2 months after the last dose. Advise pregnant women of the potential risk to the fetus.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) included total bilirubin increased (81%), calcium decreased (74%), nausea (50%), diarrhea (43%), potassium decreased (41%), vomiting (34%), decreased appetite (34%), and phosphorus decreased (27%)
The most frequently reported ≥Grade 3 adverse reactions (≥5%) included total bilirubin increased (15%), potassium decreased (15%), phosphorus decreased (8%), calcium decreased (8%), diarrhea (8%), differentiation syndrome (7%), non-infectious leukocytosis (6%), tumor lysis syndrome (6%), and nausea (5%)
Serious adverse reactions were reported in 77.1% of patients. The most frequent serious adverse reactions (≥2%) were leukocytosis (10%), diarrhea (6%), nausea (5%), vomiting (3%), decreased appetite (3%), tumor lysis syndrome (5%), and differentiation syndrome (8%). Differentiation syndrome events characterized as serious included pyrexia, renal failure acute, hypoxia, respiratory failure, and multi-organ failure

DRUG INTERACTIONS

Coadministration of IDHIFA increases the exposure of OATP1B1, OATP1B3, BCRP, and P‑glycoprotein (P‑gp) substrates, which may increase the incidence and severity of adverse reactions of these substrates. If coadministered, decrease the dosage of the substrate as recommended in the respective prescribing information and as clinically indicated.

LACTATION

Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with IDHIFA and for at least 2 months after the last dose.

Please see full Prescribing Information, including Boxed WARNING.

Reference:

Data on file, Celgene Corporation. Summit, New Jersey.

Celgene Commercial Co-pay Program Terms and Conditions

Eligibility

Patients must meet the following criteria to enroll:

Covered by commercial or private insurance
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For Celgene oral hematology products, Celgene provides assistance to reduce the co-pay of eligible patients to $25 per prescription with a maximum benefit of $10,000 per enrollment period
For Celgene IV products, the Program will cover the co-pay for each prescription of a Celgene product up to a maximum of $10,000 per enrollment period
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Additional Terms and Conditions of the Celgene Commercial Co-pay Programs

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