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Dear Pharmacist:
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Novartis Pharmaceuticals Corporation is pleased to announce the recent approval of RYDAPT® (midostaurin) capsules.
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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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RYDAPT is available by prescription only.
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Please review the following table for important packaging information:
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| RYDAPT PRODUCT INFORMATION |
| NDC Number |
0078-0698-99 |
0078-0698-19 |
| Package Strength |
25 mg |
25 mg |
| Package Size |
56 capsules |
112 capsules |
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Note: Image depicts 28‑capsule pack for photo clarity. RYDAPT will always be delivered in either 56- or 112‑capsule cartons.
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RYDAPT will be available for purchase by any licensed pharmacy from any Novartis Authorized Distributor of Record (ADR).
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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 visit www.us.rydapt.com or 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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Please see full Prescribing Information for RYDAPT® (midostaurin) capsules.
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