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FLT3 / PKC Inhibitor — AML / Mastocytosis

Midostaurin

Brand names: Rydapt

Midostaurin is an oral multi-targeted protein kinase inhibitor used in FLT3-mutated acute myeloid leukaemia (with chemotherapy) and in advanced systemic mastocytosis and related mast cell neoplasms.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It inhibits multiple tyrosine kinases including mutant and wild-type FLT3 and KIT, blocking downstream proliferative signalling in leukaemic and neoplastic mast cells.

Prescribing in practice

  • It can prolong the QT interval, so correct electrolytes and review concomitant QT-prolonging and interacting drugs before and during treatment.
  • It is a CYP3A4 substrate, so strong inducers or inhibitors can markedly alter exposure and should be managed carefully.
  • Nausea and vomiting are common, and it is taken with food to improve tolerability.

Monitoring

Monitor the full blood count, ECG including QT interval, and for pulmonary symptoms during treatment.

Counselling the patient

  • Take the capsules with food to reduce nausea.
  • Tell your team about all other medicines, as some interact significantly.
  • Effective contraception is required during treatment.

Evidence & guidelines

Benefit in FLT3-mutated AML was shown in the RATIFY trial, supporting its use with intensive chemotherapy.

Reference: RATIFY Trial (Stone et al. NEJM 2017); NICE TA523; SPC Rydapt; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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