) including nausea, vomiting (usually Grade 1-2) or injection site reactions (77.1 %; usually Grade 1-2).
The most common serious adverse reactions (> 2 %) noted from the pivotal study (AZA PH GL 2003 CL 001) and also reported in the supporting studies (CALGB 9221 and CALGB 8921) included febrile neutropenia (8.0 %) and anaemia (2.3 %). Other reported serious adverse reactions included infections such as neutropenic sepsis and pneumonia (some with fatal outcome), thrombocytopenia and haemorrhagic events (e.g. cerebral haemorrhage).
The table below contains adverse reactions associated with azacitidine treatment obtained from clinical studies and post marketing surveillance.
Frequencies are defined as: very common ( 1/10), common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class
Very common
Common
Uncommon
Infections and infestations
pneumonia*, nasopharyngitis
neutropenic sepsis*, upper respiratory tract infection, urinary tract infection, sinusitis, pharyngitis, rhinitis, herpes simplex
Blood and lymphatic system disorders
febrile neutropenia, neutropenia, leukopenia, thrombocytopenia, anaemia
bone marrow failure, pancytopenia
Immune system disorders
hypersensitivity reactions
Metabolism and nutrition disorders
anorexia
hypokalemia
Psychiatric disorders
confusional state, anxiety, insomnia
Nervous system disorders
dizziness, headache
intracranial haemorrhage, lethargy
Eye disorders
eye haemorrhage, conjunctival haemorrhage
Vascular disorders
hypertension, hypotension, haematoma
Respiratory, thoracic and mediastinal disorders
dyspnoea
dyspnoea exertional, pharyngolaryngeal pain
Gastrointestinal disorders
diarrhoea, vomiting, constipation, nausea, abdominal pain
gastrointestinal haemorrhage, haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia
Hepatobiliary disorders
hepatic failure*, progressive hepatic coma
Skin and subcutaneous tissue disorders
petechiae, pruritus, rash, ecchymosis
purpura, alopecia, erythema, rash macular
Musculoskeletal, and connective tissue disorders
arthralgia
myalgia, musculoskeletal pain
Renal and urinary disorders
renal failure*, haematuria, elevated serum creatinine
renal tubular acidosis
General disorders and administration site conditions
fatigue, pyrexia, chest pain, injection site erythema, injection site pain, injection site reaction (unspecified)
injection site: bruising, haematoma, induration, rash, pruritus, inflammation, discoloration, nodule and haemorrhage.
malaise
Investigations
weight decreased
*= rarely fatal cases have been reported
Haematologic adverse reactions
The most commonly reported adverse reactions associated with azacitidine treatment were haematological including thrombocytopenia, neu |
