The behavior of factor IX in the body |ALPROLIX® Professional

Factors VIII and IX distribute differently in the body^1-3

Factor VIII (missing in hemophilia A) is largely limited to the intravascular space (within the plasma)^1-3

Factor IX (missing in hemophilia B) distributes to the extravascular space (tissues, muscles, and joints)^3,4

Factor VIII binds to von Willebrand,
a protein located inside the plasma^1-3

Factor IX binds to type IV collagen,
which is located outside the plasma⁵

In the extravascular space, factor IX binds to type IV collagen and may play a role in coagulation, as shown in preclinical data. In hemophilia B, factor IX distributes outside of the plasma and into areas such as the tissues, muscles, and joints. Trough levels do not account for this extravascular distribution of infused factor IX.^4,5

Notice: Conclusions regarding efficacy and safety in humans cannot be made based on results from preclinical studies.

It is important to evaluate factor IX replacement therapy based on outcomes such as bleed prevention⁵

Because of the limitations in pharmacokinetic evaluation for patients with hemophilia B, it is important to evaluate factor IX replacement therapy based on outcomes such as bleed prevention.

ALPROLIX utilizes half-life extension with Fc Fusion technology^5,6

Learn about the mechanism of extension

INDICATION:

ALPROLIX is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:

On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use

ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

ALPROLIX is contraindicated in patients who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

WARNINGS AND PRECAUTIONS:

Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with factor replacement therapies, and have been reported with ALPROLIX. Discontinue use of ALPROLIX if hypersensitivity symptoms occur, and initiate appropriate treatment.
Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX. Patients using ALPROLIX should be monitored for the development of Factor IX inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor IX levels have been achieved and maintained.
The use of Factor IX products has been associated with the development of thromboembolic complications.
Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with Factor IX inhibitors and a history of allergic reactions to Factor IX. The safety and efficacy of using ALPROLIX for immune tolerance induction have not been established.

ADVERSE REACTIONS:

The most common adverse reactions (incidence ≥1%) in previously untreated patients were injection site erythema, hypersensitivity, and Factor IX inhibition. The most common adverse reactions (incidence ≥1%) in previously treated patients were headache, oral paresthesia, and obstructive uropathy.

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INDICATION:

IMPORTANT SAFETY INFORMATION

References: 1. Lenting PJ, Schooten CJM van, Denis CV. Clearance mechanisms of von Willebrand factor and factor VIII. J Thromb Haemost. 2007;5(7):1353-1360. 2. Morfini M. The history of clotting factor concentrates pharmacokinetics. J Clin Med. 2017;6(3):35. 3. Castaman G, Matino D. Hemophilia A and B: molecular and clinical similarities and differences. Haematologica. 2019;104(9):1702-1709. 4. Gui T, Reheman A, Ni H, et al. Abnormal hemostasis in a knock-in mouse carrying a variant of factor IX with impaired binding to collagen type IV. J Thromb Haemost. 2009;7(11):1843-1851. 5. Iorio A, Fischer K, Blanchette V, Rangarajan S, Young G, Morfini M; Pharmacokinetic (PK) Expert Working Group of the International Prophylaxis Study Group (the IPSG). Tailoring treatment of haemophilia B: accounting for the distribution and clearance of standard and extended half-life FIX concentrates. Thromb Haemost. 2017;117(6):1023-1030. 6. ALPROLIX. Package insert. Bioverativ Therapeutics Inc; 2023.

About Factor IX

Factors VIII and IX distribute differently in the body1-3

It is important to evaluate factor IX replacement therapy based on outcomes such as bleed prevention5

ALPROLIX utilizes half-life extension with Fc Fusion technology5,6

INDICATION:

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

INDICATION:

IMPORTANT SAFETY INFORMATION

Factors VIII and IX distribute differently in the body^1-3

It is important to evaluate factor IX replacement therapy based on outcomes such as bleed prevention⁵

ALPROLIX utilizes half-life extension with Fc Fusion technology^5,6