Basic Information
RYDAPT SOFT CAPSULE 25MG
CAPSULE, LIQUID FILLED
Regulatory Information
SIN15518P
July 30, 2018
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
Company Information
NOVARTIS (SINGAPORE) PTE LTD
NOVARTIS (SINGAPORE) PTE LTD
Active Ingredients
Strength: 25mg
Detailed Information
Contraindications
**CONTRAINDICATIONS** RYDAPT is contraindicated in patients with hypersensitivity to midostaurin or to any of the excipients. Concomitant administration of potent CYP3A4 inducers, e.g. rifampicin, St. John’s Wort _(Hypericum perforatum)_, carbamazepine, enzalutamide, phenytoin (see section INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**INDICATIONS** RYDAPT is indicated: - in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (see CLINICAL STUDIES – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).