[Durgical](https://durgical.com/en/) › [DurgiPedia](https://durgical.com/en/durgipedia/) › [Pharmacology](https://durgical.com/en/pharmacology/) › [FLT3 inhibitors](https://durgical.com/en/pharmacology/classes/flt3-inhibitors/) › Midostaurin

# Midostaurin

## FLT3 inhibitors?

FLT3 inhibitors

## High alert?

An error with this medicine can cause serious harm: double checks and protocols are used.

## Pregnancy: avoid?

Avoid in pregnancy. Midostaurin may harm the fetus: a pregnancy test is done first, women and men use contraception during and for months after treatment, and breastfeeding is…

An oral multikinase inhibitor of FLT3 and KIT, added to chemotherapy in FLT3-mutated AML and used in advanced systemic mastocytosis.

Updated Nov 12, 2026

Also called: PKC412

## Quick facts

**Group**
[FLT3 inhibitors](https://durgical.com/en/pharmacology/classes/flt3-inhibitors/)

**Target**
FLT3 receptor tyrosine kinase (also KIT and other kinases)

**Used for**
Aggressive systemic mastocytosis

**Key effects**
Nausea and vomiting · Diarrhoea · Headache

**Monitor**
FLT3 mutation test before starting

**ATC**
L01EX10

No doses: the clinician sets them by the current guideline.

On this page

- The basics Mechanism of action
- Indications
- Adverse effects
- Pharmacokinetics
- Memory aid

- Clinical What the labels mean

- Safety Contraindications
- Key interactions
- What is monitored
- Administration and safety
- Pregnancy and breastfeeding
- Nursing care

- Study Test yourself

- Connections Connections

## Mechanism of action

✂**FLT3 receptor tyrosine kinase (also KIT and other kinases)**Midostaurin

ⓘ No structure with midostaurin bound to FLT3 was found. The figure shows gilteritinib, another FLT3 inhibitor, in the ATP site of human FLT3.

**Target in 3D:** FLT3 receptor tyrosine kinase (also KIT and other kinases). PDB structure 6JQR (RCSB PDB, public domain). [View the structure at RCSB PDB](https://www.rcsb.org/structure/6JQR) · Drag to rotate · pinch to zoom

Midostaurin is a multikinase inhibitor active against mutant FLT3, wild-type KIT and the KIT D816V mutant of mastocytosis, PDGFR, SRC and protein kinase C. In AML it adds to chemotherapy by cutting off FLT3 growth signals; in mastocytosis it stops KIT-driven mast cell growth and mediator release.

- Midostaurin blocks mutant FLT3, KIT and other kinases
- Mutant FLT3 and KIT D816V stop signalling
- Leukaemic blasts and mast cells stop growing

## Indications

- Newly diagnosed FLT3-mutated acute myeloid leukaemia, with cytarabine and daunorubicin induction and cytarabine consolidation. [Acute leukaemia (AML and ALL) →](https://durgical.com/en/conditions/acute-leukaemia/)
- Aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm, and mast cell leukaemia. [Mastocytosis (cutaneous and systemic) →](https://durgical.com/en/conditions/mastocytosis/)

## Adverse effects

### Common

- Nausea and vomiting
- Diarrhoea, abdominal pain, mouth sores
- Headache, nosebleeds, sweating
- Limb swelling, musculoskeletal pain
- Fatigue, insomnia

### Serious (rare, important)

- Pulmonary toxicity: interstitial lung disease, pneumonitis
- Febrile neutropenia and infections
- Heart rhythm problems, QT prolongation
- Hypersensitivity

## Contraindications

- Hypersensitivity to midostaurin

## Key interactions

**St John's wort**
Can lower midostaurin levels; avoided.

**Grapefruit and its juice**
Can raise midostaurin levels; discussed with the treating team.

**Cytarabine and daunorubicin (given together)**
The approved AML combination; low blood counts are expected and watched.

## What is monitored

- FLT3 mutation test before starting (AML)
- Complete blood count
- New cough or breathlessness
- ECG in patients at risk of QT prolongation

## Administration and safety

- Oral capsules with food, swallowed whole, not opened or crushed.
- An antiemetic is usually given before each dose.
- If vomiting follows a dose, no extra dose is taken.

## Pregnancy and breastfeeding

Avoid in pregnancy. Midostaurin may harm the fetus: a pregnancy test is done first, women and men use contraception during and for months after treatment, and breastfeeding is stopped.

## Nursing care

- Give antiemetics before each dose and monitor intake.
- Teach to report fever, cough, wheeze or breathlessness.
- Monitor blood counts and teach infection precautions.
- Pregnancy test before starting; contraception during and for months after treatment.

## Pharmacokinetics

**Absorption**
Oral capsules twice a day with food.

## Memory aid

«Midostaurin, middle of chemo»: it rides along with induction chemotherapy in FLT3-mutated AML.

## Test yourself

Think of the answer, then tap the question to see it.

## Which two kinases explain midostaurin's two indications?

Mutant FLT3 (AML) and KIT D816V (systemic mastocytosis).

## With which chemotherapy is midostaurin combined in AML?

Cytarabine and daunorubicin induction, then cytarabine consolidation.

## Why is an antiemetic given before each dose?

Nausea and vomiting are very common.

[Add to my cards (3)](https://durgical.app/estudiar/?add=/en/pharmacology/midostaurin/)

[More Pharmacology questions →](https://durgical.com/en/practice/?f=pharmacology)

## What the labels mean

**High alert**
An error with this medicine can cause serious harm: double checks and protocols are used.

**Pregnancy: avoid**
Avoid in pregnancy. Midostaurin may harm the fetus: a pregnancy test is done first, women and men use contraception during and for months after treatment, and breastfeeding is…

## Connections

## Related drugs 3

- [Gilteritinib](https://durgical.com/en/pharmacology/gilteritinib/)
- [Cytarabine](https://durgical.com/en/pharmacology/cytarabine/)
- [Daunorubicin](https://durgical.com/en/pharmacology/daunorubicin/)

## Related conditions 2

- [Acute leukaemia (AML and ALL)](https://durgical.com/en/conditions/acute-leukaemia/)
- [Mastocytosis (cutaneous and systemic)](https://durgical.com/en/conditions/mastocytosis/)

[← Back to the class: FLT3 inhibitors](https://durgical.com/en/pharmacology/classes/flt3-inhibitors/)

Educational content on how drugs work; not a prescribing guide and no substitute for a health professional's advice. No doses are given.

Sources: [Midostaurin: MedlinePlus Drug Information](https://medlineplus.gov/druginfo/meds/a617033.html) (MedlinePlus (U.S. National Library of Medicine), 2017); [Midostaurin - NCI](https://www.cancer.gov/about-cancer/treatment/drugs/midostaurin) (National Cancer Institute, 2022); [ATCDDD - ATC/DDD Index](https://atcddd.fhi.no/atc_ddd_index/?code=L01EX10) (WHO Collaborating Centre for Drug Statistics Methodology, 2026).

## **Spotted a mistake?** We are always improving for the community. Tell us what is wrong and our team will review it. Report a mistake

Representative model, for educational purposes only.

---
Source: https://durgical.com/en/pharmacology/midostaurin/
License: CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/). Cite as: DurgiPedia (durgical.com), https://durgical.com/en/pharmacology/midostaurin/
