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Mutations in AML

AML IS A COMPLEX, HETEROGENEOUS DISEASE DRIVEN BY MULTIPLE GENE MUTATIONS, INCLUDING IDH21,2

>99% N>800

Across two studies of patients with de novo AML, more than 99% had ≥1 driver mutation.3,4

  • Driver mutations carry varying prognostic implications and may impact treatment decisions5
8%-19%

IDH2 mutations occur in up to 19% of patients with AML.6

  • Certain mutations, including IDH2, are more common in older patients7
  • IDH2 mutations are more common than IDH1 mutations, and they rarely co-occur8
  • IDH2 and IDH1 are located in distinct cellular locations. IDH2 is present in the mitochondria; IDH1 is present in the cytoplasm8
  • IDH2 is a driver mutation of AML and can readily be detected by molecular profiling at diagnosis and relapse9-11

Identifying IDH2 mutations can help inform treatment decisions9

IDHIFA is only indicated for patients with IDH2 mutations

Testing for IDH2 Mutations

GUIDELINES RECOMMEND IDH2 TESTING FOR ALL PATIENTS WITH AML9

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend testing for IDH2 mutations at diagnosis and relapse.9

  • Testing can be performed in parallel with cytogenetics
  • Molecular profiling of IDH2 mutations can be performed on bone marrow or peripheral blood using an FDA-approved test

The Abbott RealTime™ IDH2 assay is a polymerase chain reaction (PCR)-based test that is FDA-approved to help identify patients with AML for treatment with IDHIFA.12

Talk to your pathologist about including IDH2 testing at diagnosis and relapse

HCP Testing Overview

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, as early as 10 days and at 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 1 month 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 infants, advise women not to breastfeed during treatment with IDHIFA and for at least 1 month after the last dose.

Please see full Prescribing Information, including Boxed WARNING.

References:

  • Estey E, Döhner H. Acute myeloid leukaemia. Lancet. 2006;368(9550):1894-1907.
  • Burnett A, Wetzler M, Löwenberg B. Therapeutic advances in acute myeloid leukemia. J Clin Oncol. 2011;29(5):487-494.
  • Metzeler KH, Herold T, Rothenberg-Thurley M, et al; on behalf of the AMLCG Study Group. Spectrum and prognostic relevance of driver gene mutations in acute myeloid leukemia. Blood. 2016;128(5):686-698.
  • The Cancer Genome Atlas Research Network. Genomic and epigenomic landscapes of adult de novo acute myeloid leukemia. N Engl J Med. 2013;368(22):2059-2074.
  • Arber DA, Borowitz MJ, Cessna M, et al. Initial diagnostic workup of acute leukemia: guideline from the College of American Pathologists and the American Society of Hematology. Arch Pathol Lab Med. 2017;141(10):1342-1393.
  • Döhner H, Weisdorf DJ, Bloomfield CD. Acute myeloid leukemia. N Engl J Med. 2015;373(12):1136-1152.
  • Bloomfield CD, Estey E, Pleyer L, et al. Time to repeal and replace response criteria for acute myeloid leukemia? Blood Rev. 2018;32(5):416-425.
  • Medeiros BC, Fathi AT, DiNardo CD, Pollyea DA, Chan SM, Swords R. Isocitrate dehydrogenase mutations in myeloid malignancies. Leukemia. 2017;31(2):272-281.
  • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed May 9, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. The National Comprehensive Cancer Network 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.
  • Papaemmanuil E, Gerstung M, Bullinger L, et al. Genomic classification and prognosis in acute myeloid leukemia. N Engl J Med. 2016;374(23):2209-2221.
  • Patel K, Ravandi F, Ma D, et al. Acute myeloid leukemia with IDH1 or IDH2 mutation: frequency and clinicopathologic features. Am J Clin Pathol. 2011;135(1):35-45.
  • Abbott RealTime [product information]. Abbott Molecular Inc: 2017.

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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
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    • 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
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