Common adverse reactions (incidence ≥ 1%) reported in clinical trials were headache and oral paresthesia.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the multi-center, prospective, open-label clinical trial with ALPROLIX™, 123 previously treated patients (PTPs, exposed to a Factor IX containing product for ≥ 100 exposure days) were evaluated, with 115 subjects treated for at least 26 weeks and 56 subjects treated for at least 52 weeks.
Adverse reactions (ARs) were reported in 10 of 119 (8.4%) subjects treated with routine prophylaxis or episodic (on-demand) therapy. They are summarized in Table 3.
No subject was withdrawn from study due to an adverse reaction. In the study, no inhibitors were detected and no events of anaphylaxis were reported.
Table 3: Summary of Adverse Reactions
|System Organ Class||Adverse Reactions (AR)||Number of Subjects (%)
|Nervous system disorders||Headache||2 (1.7)|
|Gastrointestinal disorders||Paresthesia oral||2 (1.7)|
|Breath odor||1 (0.8)|
|General disorders and administration site conditions||Fatigue||1 (0.8)|
|Infusion site pain||1 (0.8)|
|Cardiac disorders||Palpitations||1 (0.8)|
|Renal and urinary disorders||Obstructive uropathy||1 (0.8)|
|Vascular disorders||Hypotension||1 (0.8)|
|*119 previously treated patients (PTPs) on routine prophylaxis or episodic (on-demand) therapy|
Obstructive uropathy was reported in one subject with hematuria who developed an obstructing clot in the urinary collecting system. The event resolved with hydration and the subject continued prophylactic treatment with ALPROLIX™.