Prescribing information

 

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Safety profile

The safety profile of RYDAPT plus standard intensive chemotherapy was comparable to that of placebo plus standard intensive chemotherapy.1 Few significant differences were observed between the two treatment groups in the rates of grade 3, 4 or 5 adverse events.1

  • No unexpected adverse events were reported1
  • Serious adverse events were recorded at similar rates for both RYDAPT with SOC and placebo with SOC groups:1
    • Rash/desquamation was significantly greater with RYDAPT (p=0.008)
    • Nausea was more frequent in the placebo group (p=0.05)
  • Haematological side-effects were also similar:
    • Anaemia was the only grade 3 or 4 event that occurred significantly more often with RYDAPT vs placebo (p=0.03)

The incidence of grade ≥3 AEs was similar in the RYDAPT and placebo groups1

Adverse event

(Grade ≥3)1
RYDAPT + standard intensive chemotherapy

(n=355)
Placebo + standard intensive chemotherapy

(n=354)
p value
  Number of patients (%)  
Haematologic      
Thrombocytopaenia 346 (97) 342 (97) 0.52
Neutropenia 338 (95) 339 (96) 0.86
Anaemia 329 (93) 311 (88) 0.03
Leukopenia 93 (26) 105 (30) 0.32
Lymphopenia 68 (19) 78 (22) 0.35
Non-haematologic      
Febrile neutropenia 290 (82) 292 (82) 0.84
Infection 186 (52) 178 (50) 0.60
Lymphopenia 68 (19) 78 (22) 0.35
Diarrhoea 56 (16) 54 (15) 0.92
Hypokalaemia 49 (14) 60 (17) 0.25
Pain 47 (13) 44 (12) 0.82
Increased alanine aminotransferase 45 (13) 33 (9) 0.19
Rash or desquamation 50 (14) 27 (8) 0.008
Fatigue 32 (9) 37 (10) 0.53
Nausea 20 (6) 34 (10) 0.05
  • The most frequent (incidence 30%) ADRs (all grades) in the RYDAPT plus standard intensive chemotherapy arm were febrile neutropenia, nausea, exfoliative dermatitis, vomiting, headache, petechiae and pyrexia2
  • The most frequent (incidence 10%) Grade 3/4 ADRs with RYDAPT plus standard intensive chemotherapy were febrile neutropenia, lymphopenia, device-related infection and exfoliative dermatitis2

ADR, adverse drug reaction; AE, adverse event; IV, intravenous; q12h, every 12 hours; SOC, standard of care.

SOC: A cycle was 28 days. Chemotherapy dosing during induction was cytarabine IV, 200 mg/m2/d on Days 1–7, and daunorubicin IV, 60 mg/m2/d on Days 1–3. During consolidation, high-dose cytarabine was given at a dose of 3 g/m2/d IV q12h on Days 1, 3 and 5.

 

References

  1. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation. N Engl J Med. 2017;377(5):454–464.
  2. Rydapt Summary of Product Characteristics. Novartis Pharma AG 2018.
HCP20-C026c June 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]