Midostaurin Capsule

  • Medicine Name- Rydapt 
  • API- Midostaurin
  • Packaging- Capsules
  • Strength- 25 mg
  • Manufactured by: Novartis India Ltd
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Midostaurin Capsule is a kinase inhibitor prescribed for adult patients facing specific health challenges. It’s designed for use in various conditions:

Newly Diagnosed Acute Myeloid Leukemia (AML):

  • Specifically for cases where AML is FLT3 mutation-positive, as confirmed by an FDA-approved test.
  • Administered with standard cytarabine and daunorubicin induction, followed by cytarabine consolidation.

Limitations of Use: It’s crucial to note that RYDAPT is not to be used as a standalone treatment during the induction therapy for AML.

Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis (SM) with Associated Hematological Neoplasm (AHN), or Mast Cell Leukemia (MCL):

  • Recommended for patients dealing with these specific mastocytosis-related conditions.

Dosage and Side Effects

  •  AML: 50 mg orally twice a day with food.
  • ASM, SM-AHN, and MCL: 100 mg orally twice a day with food. 


The primary adverse reactions (occurring in ≥ 20% of cases) included febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, prolonged QT on electrocardiogram (ECG), and upper respiratory tract infection. 


The predominant adverse reactions (≥ 20%) observed in cases of ASM, SM-AHN, or MCL encompassed nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.

Warning and Precautions

  • Embryo-Fetal Toxicity: Midostaurin has the potential to cause harm to the fetus if administered to a pregnant female. It is imporatant to inform individuals about the potential risks to a developing fetus.
  • Pulmonary Toxicity: Keep vigilant for signs of interstitial lung disease or pneumonitis. If patients exhibit indications of pulmonary toxicity, it is advised to discontinue Midostaurin. Fatal cases associated with pulmonary toxicity have been reported.
  • Prolonged and severe neutropenia and thrombocytopenia pose a risk in pediatric patients undergoing combination chemotherapy. This risk was observed in two cases of AML where an unauthorized form of midostaurin was used along with chemotherapy, including anthracyclines, fludarabine, and cytarabine. These patients were also given an azole antifungal, a potent CYP3A4 inhibitor, potentially amplifying midostaurin concentrations and the associated toxicity risk.


Is midostaurin approved by the FDA?

On April 28, 2017, the US FDA approved midostaurin (Rydapt; Novartis Pharmaceuticals, Inc) to treat patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML).

What category is midostaurin?

Midostaurin comes in a class of kinase inhibitors. It works by hindering the action of the abnormal protein that signals cancerous cells to multiply. This helps prevent the spread of mast and cancer cells.

Is midostaurin approved in India?

Midostaurin 25 mg Capsules: On November 09, 2017, CDSCO approved Midostaurin.

How long can you take midostaurin?

If there is no sign of your cancer, you continue on Midostaurin. Maintenance treatment means you take Midostaurin twice a day for up to 12 cycles of 28 days. This can take up to 12 months.