Excellent perioperative response across XTEND-1 and XTEND-Kids1
The hemostatic response of ALTUVIIIO was deemed “Excellent*” by the investigator/surgeon in:
14 MAJOR SURGERIES IN 13 SUBJECTS
(10 adults and 3 children)
21 MINOR SURGERIES IN 20 SUBJECTS
(12 adults and 8 children)
ALTUVIIIO delivers perioperative bleed management with a recommended pre-operative single dose of 50 IU/kg.
Additional post-operative doses of 30 IU/kg or 50 IU/kg may be administered as clinically needed.
Powerful protection in just a single infusion
100% of the patients who required a preoperative dose only needed 1 infusion to maintain homeostasis during surgery.§
* Hemostatic response during major surgery was assessed using the International Society on Thrombosis and Haemostasis (ISTH) 4-point response scale: excellent, good, moderate, or poor/none. Based on pooled data from XTEND-1 and XTEND-Kids.
† Defined as any surgical procedure, either elective or emergent, that usually involves general anesthesia and/or respiratory assistance, in which a major body cavity is penetrated and exposed, or a substantial impairment of physical or physiological functions is produced. Major surgeries include major orthopedic procedures such as arthroplasties; joint replacements of the knee, hip, and elbow; joint revisions; and ankle fusions. Other major surgeries include molar-tooth extractions, dental restoration and tooth extraction, circumcision, and rhinoplasty/mentoplasty.
‡ Median preoperative dose per surgery was 50 IU/kg (range: 12.7-61.9).
§ For 1 major surgery, no pre-operative loading dose was administered on the day of/or before surgery as the patient was on routine prophylaxis.
ALTUVIIIO: Surgical protection in fewer doses1
Perioperative dosing instructions for patients with hemophilia A undergoing major surgery1-3¶
| PREOPERATIVE | POSTOPERATIVE | |
| Dosing | Dosing | |
| Advate® | 40 to 60 IU/kg | 40 to 60 IU/kg every 8 to 24 hours to keep FVIII activity in the desired range until healing is complete |
| Adynovate® | 40 to 60 IU/kg | 40 to 60 IU/kg every 8 to 24 hours to maintain FVIII activity within the target range until there is adequate wound healing |
| ALTUVIIIO | 50 IU/kg | 30 or 50 IU/kg every 2 to 3 days may be administered as clinically needed for perioperative management |
Did you know?
In the ALTUVIIIO clinical trials, a single infusion administered up to 24 hours before surgery was sufficient, with no need for additional infusions during the procedure.1,4
¶ Prescribing information for each product defines major surgery as intracranial, intra-abdominal, or joint replacement surgery. ALTUVIIIO includes complicated dental procedures in this category. Advate® [Antihemophilic Factor (Recombinant)] and Adynovate® [Antihemophilic Factor (Recombinant), PEGylated] also include intrathoracic surgery in this category.
FVIII=Factor VIII; IU=international unit.
Indication
References: 1. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 2. Advate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. 3. Adynovate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. 4. Lissitchkov T, et al. Res Pract Thromb Haemost. 2023;7(4):100176.
