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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No subject was withdrawn from study due to an adverse reaction.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) 
Dizziness  1 (0.8) 
Dysgeusia  1 (0.8) 
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™.