"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...
Alprolix Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B (congenital Factor IX deficiency) to control and prevent bleeding episodes, for perioperative management, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. It is not indicated for induction of immune tolerance in patients with hemophilia B. Common side effects include headache, tingling sensation in the mouth, dizziness, changes in the sense of taste, breath odor, fatigue, injection site pain, palpitations, difficulty urinating, and low blood pressure.
Dose and duration of treatment with Alprolix depend on the severity of the Factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Alprolix may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Alprolix should be administered only if prescribed. It is unknown if it will harm a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Alprolix FDA Prescribing Information: Side Effects
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™.
Read the entire FDA prescribing information for Alprolix ([Coagulation Factor IX (Recombinant), Fc Fusion Protein], Lyophilized Powder for Solution For Intravenous Injection)
Additional Alprolix Information
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