Sotauric 25 Mg 25 mg Soft capsule
PDF Leaflet Revision Date: 04 September 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of FLT3 mutation-positive AML and aggressive systemic mastocytosis.
Dosage (summary)
AML: 50 mg orally twice daily; ASM, SM-AHN, MCL: 100 mg orally twice daily.
Special Populations
- Elderly (u2265 65 years)
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding; potential fetal harm.
Key Drug Interactions
- Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine)
- Strong CYP3A4 inhibitors (e.g., ketoconazole)
Contraindications
- Hypersensitivity to midostaurin or excipients
- Congestive heart failure NYHA class III or IV
- QT prolongation
Common side effects
- Nausea
- Vomiting
- Febrile neutropenia
- Exfoliative dermatitis
Counselling Points
- Take with food.
- Monitor for signs of infection.
- Avoid pregnancy during treatment.
Serious warnings
- Severe neutropenia
- Cardiac dysfunction
- Pulmonary toxicity
Important Disclaimer
The Sotauric 25 Mg 25 mg Soft capsule professional information leaflet below is the property of Novartis South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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