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| Help your patients connect with RYDAPT Care Coordinators today. |
| For both FDA-approved indications for RYDAPT, Care Coordinators are there to support your patients |
| INDICATIONS for RYDAPT® (midostaurin) capsules |
| 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. |
| RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. |
| RYDAPT is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). |
| For more information and patient eligibility for RYDAPT NOW, please visit us at www.RYDAPT‑NOW.com. |
| Novartis can help provide the support your patients need |
| RYDAPT NOW SUPPORT PROGRAM |
| With our wide range of resources and support, the RYDAPT Care Coordinators at RYDAPT NOW, brought to you by Novartis Patient Assistance Now Oncology, can help patients gain access to their prescribed medicine. |
| RYDAPT Care Coordinators are here to help by: |
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Assisting your patients with access to RYDAPT as they transition between inpatient and outpatient settings* |
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Offering support with insurance verification to help your patients understand how to get their medicine and what their financial responsibilities are |
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Providing information about prior authorization requirements |
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Initiating a benefits investigation in the inpatient setting* |
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Helping your patients find a pharmacy based on their insurance plan, and get their medication according to their plan's guidelines |
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Putting your patients in touch with a Clinical Educator who can provide information about their disease, side effects they may experience, and administration of RYDAPT† |
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For patients with newly diagnosed FLT3+ AML only. |
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This program does not replace patients’ regular interactions with their health care team. Limited to two interactions with Clinical Educators. Limitations apply. |
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To learn more about this support program and patient eligibility, or to enroll your patient, please call 1‑844‑662‑4636 or visit us at www.RYDAPT‑NOW.com.
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| IMPORTANT SAFETY INFORMATION for RYDAPT® (midostaurin) capsules |
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Do not use in patients with hypersensitivity to midostaurin or its excipients. Hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioedema |
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WARNINGS AND PRECAUTIONS
Embryofetal Toxicity
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Do not use during pregnancy. Midostaurin caused severe embryofetal abnormalities and death in animal studies |
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Verify pregnancy status of females of reproductive potential within 7 days prior to initiating RYDAPT |
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Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose |
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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 |
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Pulmonary Toxicity
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Cases of interstitial lung disease and pneumonitis, some fatal, have occurred in patients treated with RYDAPT as monotherapy or with chemotherapy |
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Monitor patients for pulmonary symptoms. Discontinue RYDAPT in patients who experience signs or symptoms of interstitial lung disease or pneumonitis without an infectious etiology |
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ADDITIONAL CONSIDERATIONS
Lactation
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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 |
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Infertility
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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 |
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Drug Interactions
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Strong CYP3A4 Inducers: Avoid concomitant use as strong CYP3A4 inducers decrease exposure to midostaurin and may reduce efficacy |
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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 |
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ADVERSE REACTIONS
Acute Myeloid Leukemia
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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%) |
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Most frequent grade ≥3 adverse reactions (≥10%) were febrile neutropenia (84%), device-related infection (16%), and mucositis (11%) |
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Most common (≥10%) lab abnormalities were alanine aminotransferase increase (71%), hypernatremia (21%), and hypocalcemia (74%) |
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Aggressive Systemic Mastocytosis (SM), SM With Associated Hematological Neoplasm, Mast Cell Leukemia
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Most common adverse reactions (≥20%) excluding lab terms were nausea (82%), vomiting (68%), diarrhea (54%), edema (40%), musculoskeletal pain (35%), abdominal pain (34%), fatigue (34%), upper respiratory tract infection (30%), constipation (29%), pyrexia (27%), headache (26%), and dyspnea (23%) |
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Grade ≥3 adverse reactions (≥5%) excluding lab terms were fatigue (9%), sepsis (9%), gastrointestinal hemorrhage (9%), pneumonia (8%), diarrhea (8%), febrile neutropenia (7%), edema (7%), dyspnea (7%), nausea (6%), vomiting (6%), abdominal pain (6%), and renal insufficiency (5%) |
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Most common (≥10%) nonhematologic grade ≥3 lab abnormalities were hyperglycemia (nonfasting) (18%), lipase increase (18%), and hyperuricemia (11%) |
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Most common (≥20%) hematologic grade ≥3 lab abnormalities were thrombocytopenia (27%), neutropenia (22%), anemia (38%) and lymphopenia (27%) |
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