Dasatrue (Dasatinib) 70mg

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

• Myelosuppression
• Bleeding-related events
• Fluid retention
• Cardiovascular events
• Pulmonary arterial hypertension
• QT prolongation
• Severe dermatologic reactions
• Tumor lysis syndrome
• Effects on growth and development in pediatric patients

Most common adverse reactions (≥15%) in patients receiving dasatinib as single-agent therapy included myelosuppression, fluid retention events, diarrhoea, headache, skin rash, haemorrhage, dyspnoea, fatigue, nausea, and musculoskeletal pain.

Most common adverse reactions (≥30%) in paediatric patients receiving dasatinib in combination with chemotherapy included mucositis, febrile neutropenia, pyrexia, diarrhoea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, oedema, infections (bacterial, viral and fungal), hypotension, decreased appetite, hypersensitivity, dyspnoea, epistaxis, peripheral neuropathy, and altered state of consciousness.

Postmarketing Experience

The following additional adverse reactions have been identified during post approval use of dasatinib. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections: hepatitis B virus reactivation

Cardiac disorders: atrial fibrillation/atrial flutter

Respiratory, thoracic, and mediastinal disorders: interstitial lung disease

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome

Renal and urinary disorders: nephrotic syndrome

Blood and lymphatic system disorders: thrombotic microangiopathy

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