Clinical Safety Summary

Safety data collected from >2,100 patients exposed to SPRYCEL in clinical studies

• Median duration of therapy was 15 months (range 0.03-31 months)

The majority of SPRYCEL-treated patients experienced adverse reactions at some time

• Most reactions were of mild-to-moderate grade
• Treatment was discontinued for adverse reactions in 14% of patients in chronic phase CML

The most frequently reported adverse reactions with SPRYCEL were:^*

Fluid retention (including pleural effusion), diarrhoea, headache, nausea, skin rash, dyspnoea, haemorrhage, fatigue, musculoskeletal pain, infection, vomiting, cough, abdominal pain, and pyrexia

• Drug-related febrile neutropenia was reported in 5% of patients^*

SPRYCEL treatment is associated with anaemia, neutropenia, and thrombocytopenia

• These occur more frequently in patients with Advanced Phase CML or with Ph+ ALL than in Chronic Phase CML

• In patients who experienced severe myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions, and permanent discontinuation of treatment occurred in 1% of patients

• * Please see the complete list of adverse events associated with SPRYCEL in the European Summary of Product Characteristics.
• †The dosage used in these studies is not recommended any longer for this patient population in the EU. The recommended starting dosage in the EU for chronic phase CML has been optimised to a 100 mg once-daily regimen, reflecting a more favourable safety profile with comparable efficacy.¹
• ‡CTC grades: Neutropenia (Grade 3 ≥0.5-1.0x109/l), Grade 4 <0.5-1.0x109/l); thrombocytopenia (Grade 3 ≥10-50x09/l, Grade 4 <10x109/l); anaemia (haemoglobin Grade 3 ≥65-80 g/l, Grade 4 <65 g/l).
• §The chronic phase data include patients treated with any dose of SPRYCEL.

Back to top