RYDAPT

Manufacturer: Novartis Pharmaceuticals Corporation

Score: 141.0

Quick Summary

RYDAPT (midostaurin) is a kinase inhibitor used for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation, and for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). The recommended dose for AML is 50 mg orally twice daily with food, and for ASM, SM-AHN, and MCL, it is 100 mg orally twice daily with food. RYDAPT has shown to improve overall survival in patients with AML and to induce a significant response in patients with ASM, SM-AHN, and MCL. However, it is associated with serious adverse reactions, including pulmonary toxicity, and is contraindicated in patients with hypersensitivity to midostaurin or its excipients.

Key Clinical Findings and Indications

Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive
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

Warning

Pulmonary toxicity, including pneumonitis and interstitial lung disease, has been reported in patients treated with RYDAPT

Contraindications

Hypersensitivity to midostaurin or any of the excipients

Adverse Reactions

Nausea
Vomiting
Diarrhea
Edema
Musculoskeletal pain
Abdominal pain
Fatigue
Upper respiratory tract infection
Constipation
Pyrexia
Headache
Dyspnea

Dosing Recommendations

General Guidance

Dose modifications may be necessary based on adverse reactions, including interruptions, reductions, or discontinuations

AML

Adult Dose

50 mg orally twice daily with food on Days 8 to 21 of each cycle of induction with cytarabine and daunorubicin and on Days 8 to 21 of each cycle of consolidation with high-dose cytarabine

Pediatric Dose

ASM, SM-AHN, and MCL

Adult Dose

100 mg orally twice daily with food

Pediatric Dose

Special Population Considerations

Pregnancy

RYDAPT may cause fetal harm when administered to a pregnant woman
There are no available data on RYDAPT use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage

Nursing Mothers

Pediatric Use

Safety and effectiveness of RYDAPT have not been established in pediatric patients
Prolonged Grade 4 neutropenia and thrombocytopenia occurred in pediatric patients with AML who received midostaurin in combination with chemotherapy

Geriatric Use

Of the 142 patients with advanced SM in clinical studies of RYDAPT, 64 (45%) were aged 65 and over, and 16 (11%) were aged 75 years and over
No overall differences in safety or response rate were observed between the subjects aged 65 and over compared with younger subjects

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