Summary of safety profile The safety of Inaqovi was evaluated in one Phase 3 study (ASTX727-02-EU) where 80 AML patients received the medicinal product. The overall safety profile for Inaqovi is described below and also reflects the known safety profile of intravenous decitabine.
Among the 80 patients who received treatment, the most common adverse drug reaction (≥ 20%) including Grade ≥ 3 was thrombocytopaenia. The most common serious adverse reactions (≥ 20%) were febrile neutropaenia and pneumonia. Deaths while on treatment occurred in 24% of patients.
The most frequent adverse reactions resulting in death included pneumonia (8%), sepsis (3%) and central nervous system haemorrhage in the setting of thrombocytopaenia (3%). Permanent discontinuation occurred in 14% of patients while on treatment.
The most frequent adverse reaction resulting in permanent discontinuation was pneumonia (5%). Treatment interruption and dose reductions occurred in 48% of patients. The most frequent adverse reaction resulting in treatment interruption and dose reduction was myelosuppression occurring in 19% of patients (n=15) (neutropaenia [13%, n=10], febrile neutropaenia [5%, n=4], and thrombocytopaenia [3%, n=2]).
The adverse reaction pneumonia led to treatment interruption and dose reduction in 5% of patients. Tabulated list of adverse reactions The safety evaluation of adverse reactions is largely based on experience with Dacogen in patients with AML.
The safety of Inaqovi in adult patients was evaluated in a safety population that included AML patients from one Phase 3 study (ASTX727-02-EU, N=80). Among the 80 patients who received Inaqovi, 38% were exposed for 6 months or longer and 6% were exposed for greater than 1 year.
Table 2 lists adverse drug reactions associated with Inaqovi (N=80), or that have been associated with intravenous decitabine, according to system organ class (SOC) in MedDRA. Within each SOC, the adverse drug reactions are ranked by frequency and then presented in order of decreasing seriousness.
The corresponding frequency category for each adverse drug reaction is 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 available data).
3 Common a The corresponding frequency category for each adverse drug reaction is based on the CIOMS III convention b Grouped terms include anal abscess, anorectal infection, bacteraemia, cellulitis, cellulitis staphylococcal, corona virus infection, coronavirus test positive, enterococcal bacteraemia, enterocolitis viral, erythema, escherichia bacteraemia, folliculitis, furuncle, gingival swelling, herpes virus infection, infection, klebsiella bacteraemia, nasal congestion, nasopharyngitis, oral candidiasis, oral herpes, oropharyngeal candidiasis, otitis externa, periodontitis, pharyngitis, polyserositis, pseudomonal bacteraemia, staphylococcal bacteraemia, staphylococcal infection, streptococcal bacteraemia, respiratory tract infection, skin infection, tooth abscess, tooth infection, upper respiratory tract infection, varicella zoster virus infection c Grouped terms include bronchitis, pneumonia d Grouped terms include sepsis, septic shock, systemic candidiasis, urosepsis e Grouped terms include bacteriuria, cystitis, dysuria, escherichia urinary tract infection, urinary tract infection, urinary tract infection enterococcal f Grouped terms include sinusitis aspergillus, sinusitis fungal g Sinusitis bacterial was not observed in the clinical trial with Inaqovi, however sinusitis (organism not specified) was observed in clinical trials with IV decitabine at a frequency of common (3%, 1%) h Based on laboratory values i Thrombocytopaenia may lead to bleeding and haemorrhagic reactions that may be fatal j […]