ALPROLIX® Professional Site | Perioperative Efficacy Data

Perioperative efficacy with ALPROLIX

Thirty-five major surgical procedures were performed in 22 subjects (age range: 10-63 years) in the adult and adolescent study and in the extension study¹

There were an additional 62 minor surgical procedures in 37 subjects in the adult and adolescent study, the pediatric study, and the extension study. Hemostatic response was assessed for 38 minor surgeries; 36 minor surgeries were rated as excellent or good and 2 as fair¹

In 100% of assessed major surgeries, hemostatic response with ALPROLIX was rated as excellent or good¹

80% (28 of 35) of the major surgeries required a single perioperative dose to maintain hemostasis during surgery¹

The median average dose per injection to maintain hemostasis during surgery was 94.7 IU/kg (range: 49 to 152). Perioperative factor IX replacement with ALPROLIX was by bolus infusion only. The safety of continuous infusion was not evaluated¹
Hemostasis was assessed by the investigator after surgery¹

Summary of Hemostatic Response for Major Surgery¹

Major Surgery	Number of Procedures (Number of Subjects)*	Excellent	Response
Major Surgery	Number of Procedures (Number of Subjects)*	Excellent	Good	Fair	Poor/ None
Ablation of Liver Lesion	1(1)	1
Arthroscopy	2(2)	2
Closure of Rectal Fistula	1(1)	1
Craniotomy†	1(1)	1
Dental Abscess	1(1)	1
Finger Amputation or Partial Amputation	2(1)	2
Hip Replacement or Repair	2(2)	1	1
Install or Removal of External Ilizarov Fixation	2(1)	2
Liver Transplant	1(1)	1
Liver Resection	1(1)	1
Orchiectomy	1(1)	1
Percutaneous-Ablation of Hepatic Carcinoma	1(1)	1
Patellar Resurfacing	1(1)	1
Pilonidal Cyst	1(1)	1
Pin Release	1(1)	1
Spinal Surgery	1(1)	1
Tendon Transfer in Right Arm	1(1)	1
Tonsillectomy	1(1)	1
Unilateral Ankle Fusion	2(2)	2
Unilateral Ankle Replacement or Revision	1(1)	1
Unilateral Knee Replacement or Revision	8(8)	6	2

*Eight subjects had more than one major surgery.^{1

†}Two surgeries were not assessed for response.¹

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

Contraindication

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. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.

ALPROLIX® offers hemostatic control for both major and minor surgeries1

Perioperative efficacy with ALPROLIX

In 100% of assessed major surgeries, hemostatic response with ALPROLIX was rated as excellent or good1

80% (28 of 35) of the major surgeries required a single perioperative dose to maintain hemostasis during surgery1

Summary of Hemostatic Response for Major Surgery1

Indication

Important Safety Information

Contraindication

Warnings and Precautions

Adverse reactions

Indication

Important Safety Information

ALPROLIX^® offers hemostatic control for both major and minor surgeries¹

In 100% of assessed major surgeries, hemostatic response with ALPROLIX was rated as excellent or good¹

80% (28 of 35) of the major surgeries required a single perioperative dose to maintain hemostasis during surgery¹

Summary of Hemostatic Response for Major Surgery¹