WATCH NOW: ALPROLIX® offers hemostatic control for both major and minor surgeries1
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)* |
Response | |
|---|---|---|---|
| Excellent | Good | ||
| 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 |
| Major Surgery |
Number of Procedures (Number of Subjects)* |
Response | |
|---|---|---|---|
| Fair |
Poor/ None |
||
| Ablation of Liver Lesion |
1(1) | ||
| Arthroscopy | 2(2) | ||
| Closure of Rectal Fistula |
1(1) | ||
| Craniotomy† | 1(1) | ||
| Dental Abscess | 1(1) | ||
| Finger Amputation or Partial Amputation |
2(1) | ||
| Hip Replacement or Repair |
2(2) | ||
| Install or Removal of External Ilizarov Fixation |
2(1) | ||
| Liver Transplant | 1(1) | ||
| Liver Resection | 1(1) | ||
| Orchiectomy | 1(1) | ||
| Percutaneous- Ablation of Hepatic Carcinoma |
1(1) | ||
| Patellar Resurfacing |
1(1) | ||
| Pilonidal Cyst | 1(1) | ||
| Pin Release | 1(1) | ||
| Spinal Surgery | 1(1) | ||
| Tendon Transfer in Right Arm |
1(1) | ||
| Tonsillectomy | 1(1) | ||
| Unilateral Ankle Fusion |
2(2) | ||
| Unilateral Ankle Replacement or Revision |
1(1) | ||
| Unilateral Knee Replacement or Revision |
8(8) | ||
*Eight subjects had more than one major surgery.1
†Two surgeries were not assessed for response.1
