Change the outlook for patients with advanced SM       View this as a Web page               Prescribing Information Important Safety Information       HELP CHANGE THE OUTLOOK OF ADVANCED SM* WITH RYDAPT         *Aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) are collectively referred to as advanced systemic mastocytosis (SM)         RYDAPT IS THE ONLY FDA-APPROVED TREATMENT FOR ADVANCED SM, INCLUDING ADULT PATIENTS WITH THE KIT D816V MUTATION       THE RYDAPT PIVOTAL STUDY WAS THE LARGEST STUDY EVER CONDUCTED FOR ADVANCED SM       • There were 2 clinical studies across advanced SM subtypes for RYDAPT® (midostaurin) capsules   • Efficacy in the RYDAPT pivotal study (D2201) was established on the basis of confirmed complete remission (CR) plus incomplete remission (ICR) by six 28-day cycles of oral RYDAPT 100 mg twice daily by modified Valent criteria for ASM and SM-AHN   • In the RYDAPT supportive study, efficacy was evaluated by the Valent criteria       LEARN MORE >       EFFICACY DEMONSTRATED IN 3 SUBTYPES OF ADVANCED SM         NE, not estimated; NR, not reached.     a Per study steering committee. Response confirmation after ≥8 weeks was required. No CRs were reported.   b Patients who received concomitant high-dose corticosteroids were considered unevaluable and were excluded from the response assessment.   c Among patients with response of CR or ICR. The estimated median follow-up for duration of response was 35.4 months overall.   d A + sign indicates a censored value.   e 25 patients were not assessable for the presence of MCL on central histopathology review, and 11 patients with unconfirmed presence of an AHN were regarded as not having AHN.           63% 46 of 73 patients with a documented KIT D816V mutation had confirmed major or partial responses with RYDAPT               65% 21 of 32 patients with prior therapy for SM had confirmed major or partial responses               44% 7 of 16 patients with wild-type or unknown KIT D816V mutation status had confirmed major or partial responses           MOST COMMON ADVERSE EVENTS IN THE ADVANCED SM STUDIES       • 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%‍)   • 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%‍)         Click here to learn about how RYDAPT can help make a difference for your adult patients with advanced SM         INDICATION 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).       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 Aggressive Systemic Mastocytosis (SM), SM With Associated Hematological Neoplasm, Mast Cell Leukemia     • 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%‍)     • 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%‍)     • Most common (≥10%) nonhematologic grade ≥3 lab abnormalities were hyperglycemia (nonfasting) (‍1‍8‍%‍), lipase increase (‍1‍8‍%‍), and hyperuricemia (‍1‍1‍%‍)     • Most common (≥20%) hematologic grade ≥3 lab abnormalities were thrombocytopenia (‍2‍7‍%‍), neutropenia (‍2‍2‍%‍), anemia (‍3‍8‍%‍) and lymphopenia (‍2‍7‍%‍)       Please see full Prescribing Information for RYDAPT® (midostaurin) capsules.       Reference: Rydapt [prescribing information]. 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