Rydapt (midostaurin)
How to buy Rydapt (midostaurin): You can order Rydapt (midostaurin) from TheSocialMedwork if the drug has not been approved or is not available in your country.
| Oncology | Leukemia |
| Marketing Authorisation Holder | Novartis Europharm Limited |
| Mode of Action | Kinase inhibitor (chemotherapy) |
| Administration | Oral |
| Regulatory agency approval | European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA |
| Strength | 25 milligram |
What is Rydapt (midostaurin) for?
Rydapt (midostaurin) is indicated for the treatment of patients with1,3:
-
Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation positive as detected by an FDA-approved test, in combination with chemotherapy (standard cytarabine and daunorubicin induction and cytarabine consolidation). Rydapt (midostaurin)is not indicated as a single-agent induction therapy for the treatment of patients with AML.
-
Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
How does Rydapt (midostaurin) work?
The active substance in Rydapt is midostaurin, a kinase inhibitor that works by blocking several enzymes that promote cell growth2,4.
Midostaurin demonstrated the ability to inhibit FLT3 receptor signalling and cell proliferation, and it induced apoptosis in leukemic cells expressing ITD and TKD mutant FLT3 receptors or overexpressing wild type FLT3 and PDGF receptors. Midostaurin also demonstrated the ability to inhibit KIT signalling, cell proliferation, and histamine release and induce apoptosis in mast cells1,4.
Is Rydapt (midostaurin) approved?
Rydapt (midostaurin) was approved for patients newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy; and for patients with systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)1,3 by:
- Food and Drug Administration (FDA) (USA) on April 28, 2017
- European Medicines Agency (EMA) (EU) on October 25, 2017
How do I take Rydapt (midostaurin)?
The standard dosage for AML is:
- 50 mg (2 capsules) orally twice daily with food.
The standard dosage for ASM, SM-AHN, and MCL is:
- 100 mg (4 capsules) orally twice daily with food.
Note: Consult your treating doctor for personalised dosing.
Are there any known side effects of Rydapt (midostaurin)?
Among the common side effects in patients with AML are low levels of white blood cells with fever (febrile neutropenia), nausea and inflammation of the mucous membranes (mucositis)1.
Among the patients with ASM, SM-AHN, or MCL the most common adverse reactions (≥ 20%) were nausea, vomiting, diarrhea, edema, musculoskeletal and abdominal pain1.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.
| Working ingredient | midostaurin |
|---|---|
| Shipping method | Standard (not temperature controlled) |
| Therapeutic Area | Haematology |
| Oncology | Leukemia |
| Indication | FLT3 mutation-positive acute myeloid leukemia (AML), Systemic mastocytosis |
| Administration | Oral |
| Mode of Action | Kinase inhibitor (chemotherapy) |
| Regulatory agency approval | European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA |
| Marketing Authorisation Holder | Novartis Europharm Limited |
| HS Code | N/A |
| CAS Number | N/A |
The safety and efficacy of Rydapt (midostaurin) for patients with AML was based on a study involving 717 previously untreated patients. Although a specific median survival rate could not be reliably estimated it emerged that patients who received Rydapt (midostaurin) in combination with chemotherapy lived longer than patients who received chemotherapy alone. In addition, patients who received Rydapt (midostaurin) in combination with chemotherapy lived for a median of 8.2 months without certain complications (failure to achieve complete remission within 60 days of starting treatment, progression of leukemia or death), compared with a median of 3 months in patients who received chemotherapy alone2,3.
The safety and efficacy of Rydapt (midostaurin) for patients with advanced systemic mastocytosis (SM) was based on a main study that enrolled 116 adult patients with relapse or progression to 0, 1, or 2 prior regimens for SM, of which 89 were considered as evaluable for response1,3. Of these, 21% achieved complete (CR) or incomplete remission (ICR) within 6 cycles, and the effect lasted for an estimated median of 35.4 months (range: 6.6+, 65.8+). The median time to response was 0.5 months and ranged from 0.1 to 3.0 months1. The efficacy of midostaurin was confirmed in other patient groups as well1.
1. Summary of Product Characteristics [FDA]: Rydapt (midostaurin) [PDF]
Novartis Pharma Co., Apr 2017.
2. FDA approves new combination treatment for acute myeloid leukemia
FDA, April 2017
3. Summary of Product Characteristics [EMA]: Rydapt (midostaurin) [PDF]
Novartis Pharma Co., Oct. 2017.
| Shipping Type | Standard |
| Shipping method | Standard (not temperature controlled) |
| Dynamic Weight | No |
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