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After more than 25 years, a new therapy is now available.1-3
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View this as a Web page
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RYDAPT is indicated: |
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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 |
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Limitations of Use |
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RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. |
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For the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM‑AHN), or mast cell leukemia (MCL) |
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Novartis Oncology Universal Co-pay Card Program |
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RYDAPT is part of the Universal Co-pay Card Program offered by Novartis Oncology.
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Commercially insured patients pay $10 per month |
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Novartis will pay the remaining co-pay, up to $15,000 per calendar year |
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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. |
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RYDAPT NOW Support Program |
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Novartis can help provide the support your patients need. |
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For both FDA-approved indications for RYDAPT, Care Coordinators are there to support your patients. |
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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. |
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RYDAPT NOW Free Supply Programs |
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For your appropriate patients with AML: RYDAPT NOW Access Program |
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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. |
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For your appropriate patients with any of 3 types of systemic mastocytosis (SM)*: RYDAPT NOW Free Trial |
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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. |
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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. |
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Includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM‑AHN), and mast cell leukemia (MCL), collectively referred to as advanced SM. |
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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. |
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IMPORTANT SAFETY INFORMATION for RYDAPT® (midostaurin) capsules |
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CONTRAINDICATIONS |
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Hypersensitivity to midostaurin or to any of the excipients |
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WARNINGS AND PRECAUTIONS |
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Embryofetal Toxicity: RYDAPT may cause fetal harm when administered to a pregnant woman. Advise of the potential risk to a fetus |
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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 |
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ADVERSE REACTIONS |
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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 |
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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 |
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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. |
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DRUG INTERACTIONS |
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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 |
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Strong CYP3A4 Inducers: Avoid concomitant use as strong CYP3A4 inducers decrease exposure to midostaurin and its active metabolites |
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USE IN SPECIFIC POPULATIONS |
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Lactation: Advise females not to breastfeed |
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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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