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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.

FOR R/R AML WITH AN IDH2 MUTATION

START WITH IDHIFA® AND STAY WITH IDHIFA®*

TARGETED THERAPY DELIVERED IN AN ORAL TABLET

*Evaluated in an open-label, single-arm, multicenter, clinical trial of patients who had R/R AML with an IDH2 mutation who were assigned a starting dose of 100 mg daily until disease progression or unacceptable toxicity. Dose reductions were allowed to manage adverse events. Efficacy was established in 199 patients based on the rate of complete response (CR) and CR with partial hematologic recovery (CRh) (23%; 95% CI, 18%-30%), median duration of CR/CRh (8.2 months; 95% CI, 4.3-19.4), and rate of conversion from transfusion dependence to independence (34%).

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QUICK TRIVIA!

Which of the following is the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommendation for IDH2 testing?1

Select one below, then hit submit to see the correct answer or continue scrolling.

QUICK TRIVIA!

Which of the following is the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommendation for IDH2 testing?1

The correct answer is...

Keep scrolling to see how IDHIFA® may help your patients who have R/R AML with an IDH2 mutation

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Did you know?

NCCN Guidelines® recommend enasidenib (IDHIFA®) for R/R AML with an IDH2 mutation1

IDHIFA® is the only targeted inhibitor of mutant IDH2

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See how IDHIFA® targets mutant IDH2 to
release the block on myeloid differentiation

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Explore the pivotal data below

Response Rates

FDA approval of IDHIFA® was based on results from

THE FIRST PIVOTAL TRIAL EXCLUSIVELY IN R/R AML WITH AN IDH2 MUTATION

IDHIFA® was studied in an open-label, single-arm, multicenter, clinical trial of patients who had R/R AML with an IDH2 mutation

IDHIFA® Efficacy Analysis

199 patients

Efficacy Analysis

IDHIFA® Safety Analysis

214 patients

Safety Analysis

  • Starting dose of 100 mg daily by mouth until disease progression or unacceptable toxicity
  • Dose reductions were allowed to manage adverse events
  • IDH2 mutations were either prospectively identified or retrospectively confirmed by the Abbott RealTime™ IDH2 assay
  • Patients were a median age of 68 years old and had a median of 2 prior therapies
  • Efficacy was established on the basis of the rate of CR*/CRh, the duration of response, and the rate of conversion from transfusion dependence to transfusion independence§
  • The median follow-up was 6.6 months (range, 0.4 to 27.7)

*CR was defined as <5% of blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets >100,000/µL and ANC >1,000/µL).

CRh was defined as CR requirement for blast count, no evidence of disease, but only partial recovery of peripheral blood counts (platelets >50,000/µL and ANC >500/µL).

Duration of response was defined as time since first response of CR or CRh to relapse or death, whichever is earlier.

§Patients were defined as transfusion independent if they received no RBC or platelet transfusions within any 56-day post-baseline period.

ANC, absolute neutrophil counts; CI, confidence interval; RBC, red blood cell.

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SELECTED BASELINE CHARACTERISTICS

Demographic and disease characteristics
R/R AML, N=199 (%)

100-mg daily dose

Median age in years
68 (range, 19-100)
Median time from initial AML diagnosis in months (172 patients)11.3 (range, 1.2-129.1)
ECOG PSa
046 (23)
1124 (62)
228 (14)
Relapsed AML95 (48)
Refractory AML104 (52)
IDH2 mutationb
R140155 (78)
R17244 (22)
Prior stem cell transplantation for AML25 (13)
Cytogenetic risk status
Intermediate98 (49)
Poor54 (27)
Missing/failure47 (24)
Transfusion dependent at baselinec157 (79)
Number of prior anticancer regimensd
1 89 (45)
2 64 (32)
≥3 46 (23)
Median number of prior therapies 2 (range, 1-6)

aOne patient had missing baseline ECOG PS.

bFor 3 patients with different mutations detected in bone marrow compared to blood, the result of blood is reported.

cPatients were defined as transfusion dependent at baseline if they received any RBC or platelet transfusions within the 8-week baseline period.

dIncludes intensive and/or nonintensive therapies.

ECOG PS, Eastern Cooperative Oncology Group performance status.

In this challenging clinical setting,

IDHIFA® ACHIEVED DURABLE AND CLINICALLY MEANINGFUL RESPONSES

RATE OF CR/CRh

CR/CRh 23%
n=46/199
(95% CI, 18%-30%)
CR 19%
n=37/199
(95% CI, 13%-25%)
CRh 4%
n=9/199
(95% CI, 2%-8%)

MEDIAN DURATION CR/CRh

8.2
months
n=46/199
Patients
achieving CR/CR
h
(95% CI, 4.3-19.4)
8.2
months
n=37/199
Patients
achieving CR
(95% CI, 4.7-19.4)
9.6
months
n=9/199
Patients
achieving CR
h
(95% CI, 0.7-NA)

NA, not available.

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ADDITIONAL OUTCOMES: BEST OBJECTIVE RESPONSE2

Figure depicts the FDA-adjudicated CR/CRh rates and other parameters retrospectively determined by the sponsor using the pivotal data set (N=199).

ORR 33%a
n=65/199
(95% CI, 26%-40%)
CR 19%
n=37/199
(95% CI, 13%-25%)
MLFS 8%
n=15/199
47%

(n=94/199)

STABLE DISEASE

12%

(n=23/199)

PROGRESSIVE DISEASE

1%

(n=1/199)

NOT EVALUABLE

Overall response rate (ORR) is defined as CR + CRh + PR + MLFS.

aPercentages are based on the number of subjects in each group.

MLFS, morphologic leukemia-free state for subjects with AML; PR, partial response.

LIVE POLL!

When do you expect to see a potential CR or CRh after starting a patient on IDHIFA®?

Select one below, then hit submit to see how others responded or continue scrolling.

LIVE POLL!

Your response has been recorded. See below for how others responded.

When do you expect to see a potential CR or CRh after starting a patient on IDHIFA®?

Poll Results

More data below

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WITH IDHIFA®, RESPONSES DEEPENED OVER TIME FOR SOME PATIENTS ACHIEVING CR/CRh

MEDIAN TIME TO FIRST AND BEST RESPONSE

To allow time for clinical response, continue patients on IDHIFA® for at least 6 months or until disease progression or unacceptable toxicity

Expert Views

EXPERT VIEWPOINT: WATCH A theoretical PATIENT CASE DISCUSSION

Dr Hetty Carraway and Dr Daniel A Pollyea discuss a theoretical patient with R/R AML who relapsed after intensive induction therapy, the decision to start IDHIFA®, and outcomes from the pivotal trial

I educate patients regarding what to expect…both patients and practitioners should recognize that responses to IDHIFA® may not be immediate, and that responses could deepen over time.

– Dr Daniel A Pollyea, MD, MS

Dr Hetty Carraway and Dr Daniel A Pollyea have been paid by Bristol Myers Squibb to participate in this video.

Dr Hetty Carraway is an Associate Professor of Medicine at the Cleveland Clinic.

Dr Daniel A Pollyea is an Associate Professor of Medicine and Clinical Director of Leukemia Services, Division of Hematology at the University of Colorado School of Medicine.

Resource Corner

Support for when you're talking to appropriate patients about IDHIFA®

IDHIFA® Starting Treatment Guide

Download the “Starting Treatment”
guide for patients

See transfusion data and safety below

Transfusion Independence

ACHIEVING TRANSFUSION INDEPENDENCE IS CLINICALLY MEANINGFUL

34%

(n=53/157)

34% of patients who were RBC and/or platelet transfusion dependent at baseline achieved transfusion independence during any 56‍-‍day post-baseline period*

  • Of these 53 patients, 27 had not achieved a CR/CRh at the time of follow-up2
76%

(n=32/42)

76% of patients who were independent of both RBC and platelet transfusions at baseline remained transfusion independent during any 56-day post-baseline period

43% of patients (85/199) on IDHIFA® became or remained transfusion independent during any 56-day post-baseline period

*Patients were defined as transfusion independent if they received no RBC or platelet transfusions within any 56-day post-baseline period.

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ADDITIONAL DATA FOR TRANSFUSION STATUS IN PATIENTS WHO HAD R/R AML WITH AN IDH2 MUTATION2

TRANSFUSION STATUS BY RESPONSE TYPE (N=199)

Post-baseline TIPost-baseline TD
CR/CRh (n=46)
RBC or platelet TD at baseline263
RBC or platelet TI at baseline161
Total424
NON-CR/CRh (n=153)
RBC or platelet TD at baseline27101
RBC or platelet TI at baseline169
Total43110
All (N=199)
RBC or platelet TD at baseline53104
RBC or platelet TI at baseline3210
Total85114

TD, transfusion dependent;
TI, transfusion independent.

Safety

IDHIFA® OFFERS A DIFFERENT SAFETY PROFILE IN R/R AML

Adverse Reactions (ARs) reported in ≥10% (any grade) or ≥3% (grades 3-5) of patients with R/R AML

Body system
AR
All grades
N=214 (%)
≥Grade 3
N=214 (%)
Gastrointestinal disordersa
Nausea107 (50)11 (5)
Diarrhea91 (43)17 (8)
Vomiting73 (34)4 (2)
Metabolism and nutrition disorders
Decreased appetite73 (34) 9 (4)
Tumor lysis syndrome (TLS)b13 (6) 12 (6)
Blood and lymphatic system disorders
Differentiation syndromec29 (14)15 (7)
Noninfectious leukocytosis26 (12)12 (6)
Nervous system disorders
Dysgeusia25 (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.

cDifferentiation syndrome can be associated with other commonly reported events such as respiratory failure, dyspnea, hypoxia, pyrexia, peripheral edema, rash, or renal insufficiency.

  • Other clinically significant ARs occurring in ≤10% of patients included:
    • Respiratory, thoracic, and mediastinal disorders (pulmonary edema, acute respiratory distress syndrome)
  • The median duration of exposure to IDHIFA® was 4.3 months (range, 0.3 to 23.6)
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Most common (≥20%) new or worsening laboratory abnormalities reported in patients with R/R AML

Parametera All grades (%)≥Grade 3 (%)
Total bilirubin increased8115
Calcium decreased748
Potassium decreased4115
Phosphorus decreased278

aIncludes abnormalities occurring up to 28 days after last IDHIFA® dose, if new or worsened by at least 1 grade from baseline, or if baseline was unknown. The denominator varies based on data collected for each parameter (N=213, except phosphorus [N=209]).

ADDITIONAL ANALYSIS: THE FREQUENCY OF ARs OVER TIME2

ARs reported in ≥10% (any grade) or ≥3% (grades 3-5) of patients with R/R AML

35% FREQUENCY OF ARs 30 % 25% 20 % 15 % 10 % 5% 0% Nausea Cycle 1 N=168 Cycle 3 N=214 N=100 Cycle 6 N=193 Cycle 2 N=121 Cycle 5 N=146 Cycle 4 Diarrhea Vomiting Decreased appetite Tumor lysis syndrome Differentiation syndrome Noninfectious leukocytosis Dysgeusia
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PLACEHOLDER CONTENT

DIFFERENTIATION SYNDROME MAY OCCUR WITH IDHIFA®

It may be life-threatening or fatal if not treated

Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells.

14%
14% of patients experienced differentiation syndrome (n=29/214)
7%
7% of patients experienced ≥Grade 3 differentiation syndrome
(n=15/214)
4%
4% of patients required dose interruption due to differentiation syndrome

Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, as early as 1 day and up to 5 months after IDHIFA® initiation

Resource Corner

Wallet cards for your patients taking IDHIFA® and their caregivers

IDHIFA® Patient Wallet Cards

These wallet cards are an easy method for alerting medical personnel outside their regular healthcare team about IDHIFA® treatment and differentiation syndrome

Keep scrolling to see a discussion on patient management, as well as dose modifications from the trial

EXPERT VIEWPOINT: WATCH NOW

Dr Harry Erba and Marilyn Pritchard, RN discuss managing patients receiving IDHIFA®, including diagnosing and treating differentiation syndrome and other adverse events

Distinguishing differentiation syndrome from progressive disease can be difficult. That’s because the symptoms of differentiation syndrome are nonspecific and can resemble progressing AML.

– Dr Harry Erba, MD, PhD

Dr Harry Erba and Marilyn Pritchard, RN have been paid by Bristol Myers Squibb to participate in this video.

DOSE MODIFICATIONS IN THE CLINICAL TRIAL

DOSE INTERRUPTION

43%

(n=92/214)

43% of patients experienced an AR leading to dose interruption

  • The most common ARs leading to interruption were differentiation syndrome (4%) and leukocytosis (3%)

DOSE REDUCTION

5%

(n=10/214)

5% of patients had a dose reduction due to an AR

  • No AR required dose reduction in more than 2 patients

THERAPY DISCONTINUATION

17%

(n=36/214)

17% of patients permanently discontinued therapy due to an AR

  • The most common reason for discontinuation was leukocytosis (1%)
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Dose modifications for ARs

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Next up, dosing

Dose modifications for IDHIFA®-related toxicities

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 2a 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
Other Grade 3a or higher toxicity considered related to treatment, including TLS
  • Interrupt IDHIFA® until toxicity resolves to Grade 2a or lower
  • Resume IDHIFA® at 50 mg daily; may increase to 100 mg daily if toxicities resolve to Grade 1a or lower
  • If Grade 3a or higher toxicity recurs, discontinue IDHIFA®

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

ULN, upper limit of normal.

Dosing

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

One 100-mg IDHIFA® Tablet

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

Also available in 50-mg tablets

Water Glass Icon

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

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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

There are no contraindications to IDHIFA®.

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Thank you for taking this journey through IDHIFA®

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FOR PATIENTS WHO HAVE R/R AML WITH AN IDH2 MUTATION

START WITH IDHIFA® AND STAY WITH IDHIFA®*

TARGETED THERAPY DELIVERED IN AN ORAL TABLET

*Evaluated in an open-label, single-arm, multicenter, clinical trial of patients who had R/R AML with an IDH2 mutation who were assigned a starting dose of 100 mg daily until disease progression or unacceptable toxicity. Dose reductions were allowed to manage adverse events. Efficacy was established in 199 patients based on the rate of complete response (CR) and CR with partial hematologic recovery (CRh) (23%; 95% CI, 18%-30%), median duration of CR/CRh (8.2 months; 95% CI, 4.3-19.4), and rate of conversion from transfusion dependence to independence (34%).

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.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed July 7, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Data on file, Celgene Corporation. Summit, New Jersey.

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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

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

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  • 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
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  • The Program cannot be combined with any other coupon, rebate, voucher, free trial, or similar offer
  • The Program is not insurance
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