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Alprolix

Last reviewed on RxList: 11/28/2017
Alprolix Side Effects Center

Last reviewed on RxList 11/28/2017

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. Alprolix is not indicated for induction of immune tolerance in patients with hemophilia B. Common side effects of Alprolix include

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.

Alprolix Professional 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No subject was withdrawn from study due to an adverse reaction.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 (%) 
N=119* 
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™.

Read the entire FDA prescribing information for Alprolix ([Coagulation Factor IX (Recombinant), Fc Fusion Protein], Lyophilized Powder for Solution For Intravenous Injection)

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© Alprolix Patient Information is supplied by Cerner Multum, Inc. and Alprolix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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