Target FLT3+ AML with appropriate testing       View this as a Web page               Changing the diagnostic paradigm for newly diagnosed AML with FLT3 testing     * AML, acute myeloid leukemia.       COMPLETE FLT3 MUTATION TESTING IS AN IMPORTANT SELECTIVE CLINICAL FACTOR IN NEWLY DIAGNOSED AML3-5       • Testing should be performed during the diagnostic workup in all patients with newly diagnosed AML for both FLT3 ITD and TKD mutations, in parallel with cytogenetic testing, to identify appropriate patients for targeted treatment options3-6   • LeukoStrat® CDx FLT3 Mutation Assay is the only FDA-approved FLT3 companion diagnostic test for AML†   –   Bone marrow or peripheral blood samples should be sent out within a maximum of 4 days after collection, with a typical turnaround time of 2 to 3 days for results7   • NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia recommend molecular genetic testing for AML mutations during the initial patient workup to establish the diagnosis4     * Approximately 41% of patients with AML did not receive FLT3 mutation testing, based on a 2016 survey of oncologists and pathologists (n=75) and records of 192 patients with AML. Data collected from Ipsos Oncology MDx Biomarker Test in AML study (October-November 2016).   † FLT3 mutation testing is performed by The Laboratory for Personalized Molecular Medicine® (LabPMM)®, a subsidiary of Invivoscribe Technologies, Inc., which has gained FDA approval for its FLT3 test as a companion diagnostic for RYDAPT in newly diagnosed FLT3+ AML. Laboratory for Personalized Molecular Medicine is a registered trademark of Invivoscribe Technologies, Inc.         INDICATION RYDAPT is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by an FDA-approved test.       LIMITATIONS OF USE RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.       IMPORTANT SAFETY INFORMATION for RYDAPT® (midostaurin) capsules CONTRAINDICATIONS     • Do not use in patients with hypersensitivity to midostaurin or its excipients. Hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioedema       WARNINGS AND PRECAUTIONS Embryofetal Toxicity     • Do not use during pregnancy. Midostaurin caused severe embryofetal abnormalities and death in animal studies     • Verify pregnancy status of females of reproductive potential within 7 days prior to initiating RYDAPT     • Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose     • Males taking RYDAPT should use effective contraception with females of reproductive potential and pregnant women and for at least 4 months after the last dose     • Pregnancy exposure registry to monitor pregnancy outcomes: Females who may have been exposed to RYDAPT during pregnancy, directly or through a male partner receiving RYDAPT, should contact Novartis Pharmaceuticals Corporation at 1-8‍88-6‍69-66‍82 and/or at ht‍tps://p‍si.nov‍artis.c‍om       Pulmonary Toxicity     • Cases of interstitial lung disease and pneumonitis, some fatal, have occurred in patients treated with RYDAPT as monotherapy or with chemotherapy     • Monitor patients for pulmonary symptoms. Discontinue RYDAPT in patients who experience signs or symptoms of interstitial lung disease or pneumonitis without an infectious etiology       ADDITIONAL CONSIDERATIONS Lactation     • Because of the potential for serious adverse reactions in breastfed infants from RYDAPT, advise women not to breastfeed during treatment with RYDAPT and for at least 4 months after the last dose       Infertility     • Based on findings in animals, RYDAPT may impair fertility in females and males of reproductive potential. It is unknown whether these effects on fertility are reversible       Drug Interactions     • Strong CYP3A4 Inducers: Avoid concomitant use as strong CYP3A4 inducers decrease exposure to midostaurin and may reduce efficacy     • Strong CYP3A4 Inhibitors: Coadministration with strong CYP3A4 inhibitors may increase midostaurin concentrations and may increase the risk of toxicity. Monitor patients for increased risk of adverse reactions, especially during the first week of RYDAPT use in each chemotherapy cycle and the first week of consecutive RYDAPT administration. Consider alternative therapies that do not strongly inhibit CYP3A4 activity       ADVERSE REACTIONS Acute Myeloid Leukemia     • Most common adverse reactions (≥20%) were febrile neutropenia (83%), nausea (83%), mucositis (66%), vomiting (61%), headache (46%), petechiae (36%), musculoskeletal pain (33%), epistaxis (28%), device-related infection (24%), hyperglycemia (20%), and upper respiratory tract infection (20%)     • Most frequent grade 3/4 adverse reactions (≥10%) were febrile neutropenia (84%), device-related infection (16%), and mucositis (11%)     • Most common (≥10%) lab abnormalities were alanine aminotransferase increase (71%), hypernatremia (21%), and hypocalcemia (74%)       Please see full Prescribing Information for RYDAPT® (midostaurin) capsules.       FLT3, FMS-like tyrosine kinase 3; ITD, internal tandem duplication; TKD, tyrosine kinase domain.       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.       References: 1. Data on file. Ipsos Oncology MDx: biomarker testing in AML: US 2016 Q4. Novartis Pharmaceuticals Corp; 2016. 2. Data on file. US Rydapt AML FLT3 Testing and Rydapt AML Patients. Novartis Pharmaceuticals Corp; 2018. 3. Patnaik MM. The importance of FLT3 mutational analysis in acute myeloid leukemia [published online November 22, 2017]. Leuk Lymphoma. doi:10.1080/10428194.2017.1399312. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.2.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed August 1, 2018. To view the most recent and complete version of the guideline, go online to NC‍CN.o‍rg. 5. 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. 6. De Kouchkovsky I, Abdul-Hay M. Acute myeloid leukemia: a comprehensive review and 2016 update. Blood Cancer J. 2016;6(7):e441. 7. LeukoStrat® CDx FLT3 Mutation Assay technical flyer. Invivoscribe website. ht‍tps://w‍ww.inviv‍oscribe.c‍om/upl‍oads/prod‍ucts/informationalDownloads​/LabPMM-Flyer_Leuko‍strat-CDx_FLT3_8.5x11_20170420.p‍df. Accessed July 24, 2018.       This is a sponsored message from DMD on behalf of Novartis Pharmaceuticals Corporation. DMD provides sponsored health care–related messages from trusted third parties. This material is intended specifically and exclusively for US health care professionals. You are receiving this email because you have subscribed and agreed to receive information from the DMD email list.       If you prefer not to receive further messages from DMD, please click here and confirm your request.       DMD 10‍255 W. 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