Tolerability during the maintenance phase with RYDAPT1
Single-agent maintenance therapy was evaluated in 205 patients (RYDAPT n=120, placebo n=85) in the RATIFY trial
The overall incidence of ADRs during the maintenance phase was generally lower than during the standard induction and consolidation phases. A difference in the type and severity of ADRs was observed
ADRs with ≥5% difference between study arms during the maintenance phase1,2
Adverse Drug Reactions | RYDAPT (n=84) % |
Nausea | 46.4 |
Hyperglycaemia | 20.2 |
Vomiting | 19 |
QT prolongation | 11.9 |
Adverse Drug Reactions | Placebo (n=56) % |
Nausea | 17.9 |
Hyperglycaemia | 12.5 |
Vomiting | 5.4 |
QT prolongation | 5.4 |
The most frequent grade 3/4 haematological abnormalities reported in patients during the maintenance phase with RYDAPT vs placebo were absolute neutrophil count decrease (20.8% vs 18.8%) and leukopenia (7.5% vs 5.9%)1
For patients who reached the maintenance phase, the median duration of exposure was 336 days in both arms2
Contraindications: Patients with hypersensitivity to midostaurin or to any of the excipients. Concomitant administration of potent CYP3A4 inducers1
Warnings and precautions include neutropenia and infections, cardiac dysfunction, pulmonary toxicity, embryo-fetal toxicity and lactation, severe hepatic impairment, severe renal impairment, interactions, and excipients.1 Please see the full safety information and the Basic Succinct Statement to learn more
References: 1. RYDAPT [Summary of Product Characteristics]. Novartis Pharma AG; 2017. 2. Data on file. Study no. CPKC412A2301. Novartis Pharmaceuticals Corp; 2016.