Alprolix
- Generic Name: [coagulation factor ix (recombinant), fc fusion protein], lyophilized powder for solution for intravenous injection
- Brand Name: Alprolix
Alprolix ([Coagulation Factor IX (Recombinant), Fc Fusion Protein], Lyophilized Powder for Solution For Intravenous Injection) side effects drug center
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- headache,
- numbness and tingling sensation in the mouth,
- dizziness,
- changes in the sense of taste,
- breath odor,
- fatigue,
- injection site pain,
- heart palpitations,
- difficulty urinating, and
- low blood pressure (hypotension).
- weight gain, swelling in your waist, hands, or lower legs;
- loss of appetite;
- fever or chills;
- continued bleeding after treatment;
- new or worsened bleeding; or
- signs of excessive blood clotting--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, or pain, swelling, warmth and redness in one or both legs.
- nausea;
- headache;
- dizziness;
- altered sense of taste;
- mild skin rash; or
- pain, redness, itching, stinging, or other irritation where the medicine was injected.
What Is Alprolix?
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.
What Are Side Effects of Alprolix?
Common side effects of Alprolix include
Dosage for Alprolix
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.
What Drugs, Substances, or Supplements Interact with Alprolix?
Alprolix may interact with other drugs. Tell your doctor all medications and supplements you use.
Alprolix During Pregnancy or Breastfeeding
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.
Additional Information
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.
Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, tightness in your chest, difficult breathing, fast heartbeats, blue lips, feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
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.
Read the entire detailed patient monograph for Alprolix ([Coagulation Factor IX (Recombinant), Fc Fusion Protein], Lyophilized Powder for Solution For Intravenous Injection)
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)
© 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.