After more than 25 years, a new therapy is now available.1-3

 
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RYDAPT® (midostaurin) 25 mg capsules
RYDAPT is now approved
 
    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.    
 
    For the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM‑AHN), or mast cell leukemia (MCL)    
 
       
 
    Novartis Oncology Universal Co-pay Card Program    
 
    RYDAPT is part of the Universal Co-pay Card Program offered by Novartis Oncology.
   
 
    Commercially insured patients pay $10 per month    
 
    Novartis will pay the remaining co-pay, up to $15,000 per calendar year    
 
    Limitations apply. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice.    
 
    For full Terms and Conditions, go to www.copay.novartisoncology.com or call 1‑87‍7‑57‍7‑7756.    
 
    RYDAPT NOW Support Program    
 
    Novartis can help provide the support your patients need.    
 
    For both FDA-approved indications for RYDAPT, Care Coordinators are there to support your patients.    
 
    To learn more about this support program and patient eligibility, or to enroll your patient, please call 1‑800‑282‑7630 or visit us at www.us.rydapt.com.    
 
    RYDAPT NOW Free Supply Programs    
 
    For your appropriate patients with AML: RYDAPT NOW Access Program    
 
    If you prescribe RYDAPT for newly diagnosed FLT3+ AML based on the approved label and there is a delay in your patients' insurance coverage as they transition out of the hospital, they may be eligible to receive a free 14‑day supply of RYDAPT shipped directly to their home to avoid disruption in their treatment.    
 
    For your appropriate patients with any of 3 types of systemic mastocytosis (SM)*: RYDAPT NOW Free Trial    
 
    If you prescribe RYDAPT for any of 3 types of SM, your patients may be eligible to receive a free 28‑day supply of RYDAPT shipped directly to their home or another convenient location.    
 
    No purchase of RYDAPT is required. Novartis cannot guarantee that every patient who enrolls in RYDAPT NOW will be successful in obtaining insurance coverage for treatment.    
 
  * Includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM‑AHN), and mast cell leukemia (MCL), collectively referred to as advanced SM.    
 
 
    RYDAPT NOW is brought to you by Novartis Patient Assistance Now Oncology Patient Assistance Now Oncology (PANO)    
 
    We are committed to providing the most up-to-date, accurate, and timely medical information to health care professionals. For additional details regarding RYDAPT, please call Medical Information at 1‑844‑ONC‑INFO (662‑4636), Monday through Friday, 8:30 AM to 5:00 PM ET.    
 
    IMPORTANT SAFETY INFORMATION for RYDAPT® (midostaurin) capsules    
 
    CONTRAINDICATIONS    
    Hypersensitivity to midostaurin or to any of the excipients    
 
    WARNINGS AND PRECAUTIONS    
    Embryofetal Toxicity: RYDAPT may cause fetal harm when administered to a pregnant woman. Advise of the potential risk to a fetus    
 
    Pulmonary Toxicity: Monitor for symptoms of interstitial lung disease or pneumonitis. Discontinue RYDAPT in patients with signs or symptoms of pulmonary toxicity. Fatal cases have occurred    
 
    ADVERSE REACTIONS    
    AML: The most common adverse reactions (≥20%) were febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, and upper respiratory tract infection    
 
    ASM, SM‑AHN, or MCL: The most common adverse reactions (≥20%) were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea    
 
    To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1‑88‍8‑66‍9‑6682 or FDA at 1‑80‍0‑FD‍A‑1088 or www.fda.gov/medwatch.    
 
    DRUG INTERACTIONS    
    Strong CYP3A4 Inhibitors: Strong CYP3A4 inhibitors may increase exposure to midostaurin and its active metabolites. Consider alternative therapies that do not strongly inhibit CYP3A4 or monitor for increased risk of adverse reactions    
 
    Strong CYP3A4 Inducers: Avoid concomitant use as strong CYP3A4 inducers decrease exposure to midostaurin and its active metabolites    
 
    USE IN SPECIFIC POPULATIONS    
    Lactation: Advise females not to breastfeed    
 
    Please see full Prescribing Information for RYDAPT® (midostaurin) capsules.  
 
    References: 1. Schiller GJ. High-risk acute myelogenous leukemia: treatment today…and tomorrow. Hematology Am Soc Hematol Educ Program. 2013;2013:201-208. 2. Lin TL, Levy MY. Acute myeloid leukemia: focus on novel therapeutic strategies. Clin Med Insights Oncol. 2012;6:205-217. 3. Rydapt [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2017.  
   
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