Dosing & Administration

IDHIFA® OFFERS CONVENIENT, DAILY ORAL THERAPY THAT PATIENTS CAN TAKE AT HOME

Starting dose:
One 100-mg IDHIFA® tablet once daily.

Swallow whole with water. Do not split or crush the tablets.

Take IDHIFA® tablets orally about the same time each day with or without food.

IDHIFA® should be taken until disease progression or unacceptable toxicity
If dose 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 TLS 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
IDHIFA® is also available in 50-mg tablets

There are no contraindications to IDHIFA®.

For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response

When speaking to your patients about IDHIFA® dosing, you may find it helpful to refer to the IDHIFA® Patient Brochure.

IDHIFA® Patient
Brochure

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Dose Modifications for Toxicities

Dose MODIFICATIONS FOR IDHIFA®-RELATED TOXICITIES

RECOMMENDATIONS FOR DIFFERENTIATION SYNDROME, NONINFECTIOUS LEUKOCYTOSIS, AND ELEVATED BILIRUBIN

Adverse reaction	Recommended action
Differentiation syndrome	If differentiation syndrome is suspected, administer systemic corticosteroids and initiate hemodynamic monitoring 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 Resume IDHIFA® when signs and symptoms improve to Grade 2^a or lower
Noninfectious leukocytosis (WBC count greater than 30x10⁹/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 30x10⁹/L
Elevation of bilirubin greater than 3x the 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 2x ULN

ULN, upper limit of normal.

RECOMMENDATIONS FOR OTHER GRADE 3^a OR HIGHER TOXICITY CONSIDERED RELATED TO TREATMENT, INCLUDING TLS

INTERRUPT IDHIFA® until toxicity resolves to Grade 2^a or lower.

RESUME IDHIFA® at 50 mg daily; may increase to 100 mg daily if toxicities resolve to Grade 1^a or lower.

DISCONTINUE IDHIFA® therapy if Grade 3^a or higher toxicity recurs.

^aGrade 1 is mild, Grade 2 is moderate, Grade 3 is serious, Grade 4 is life-threatening.

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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. Pregnant women, patients becoming pregnant while receiving IDHIFA, or male patients with pregnant female partners should be apprised 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

LACTATION

Many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children, 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.

Celgene Commercial Co-pay Program Terms and Conditions

Eligibility

Patients must meet the following criteria to enroll:

Covered by commercial or private insurance
Reside in the United States or US territory
Not participating in a federal or state-funded healthcare program, including, but not limited to, Medicare (Parts B, C, and D) or Medicaid, Medigap, CHAMPUS, VA, DOD, or Tricare
Gross annual household income must not exceed $100,000
- Gross household income is the total income before income tax deductions from all people living in your household. Gross income refers not only to the salaries and benefits received, but also to receipts from any personal business, investments, dividends, and other income

Program Benefits

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
- In order to receive the Program benefits for a Celgene IV product, patients or their providers must submit an Explanation of Benefits (EOB) form
Patients are responsible for any costs that exceed the Program’s $10,000 maximum
The Program will not cover, and shall not be applied toward, the cost of any dosing procedure, any other healthcare provider service or supply charges or other treatment costs, or any costs associated with a hospital stay

Program Timing

If eligible, patients will be enrolled from the date of enrollment through the end of the then current calendar year

Additional Terms and Conditions of the Celgene Commercial Co-pay Programs

Patients, pharmacists, and healthcare providers must not seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this Program. Patients must not seek reimbursement from any health savings, flexible spending, or other healthcare reimbursement accounts for the amount of assistance received from the Program
Acceptance of this offer confirms that this offer is consistent with your insurance and that you will report the value of the co-pay assistance you receive as may be required by your insurance provider
Only valid in the United States and US territories; this offer is void where prohibited by law, taxed or restricted. Absent a change in Massachusetts law, effective July 1, 2019, Massachusetts residents will no longer be eligible to participate in this Program
The Program benefits are nontransferable
Acceptance in this Program is not conditioned on any past, present, or future purchase, including additional doses
The Program cannot be combined with any other coupon, rebate, voucher, free trial, or similar offer
The Program is not insurance
Celgene reserves the right to rescind, revoke, or amend this Program at any time without notice