TachoSil (Page 5 of 6)
14.3 Pediatric
In a pediatric subset of a randomized, open-label, parallel group, multi-center trial comparing TachoSil with comparator the efficacy of TachoSil for the secondary treatment of local bleeding in pediatric patients undergoing hepatic surgery was evaluated.
In the randomized part of the study, eight patients were treated with TachoSil and nine patients were treated with the comparator. After the randomization phase, an additional 12 patients were treated with TachoSil in a single extension arm to reach 20 patients exposed to TachoSil. A similar proportion of male and female pediatric patients were treated overall in the trial (48% and 52%, respectively). The majority of patients were White/Caucasian (79%) and the most common ethnicity was non-Hispanic/non-Latino (69%). The mean age was slightly higher in the TachoSil group (4.58 years; range 0.4, 13.0 years) than in the comparator group (3.77 years; range 0.4, 16.0 years).
A larger proportion of the patients in the TachoSil group (7/8 [88%]) than in the comparator group (4/9 [44%]) achieved hemostasis within three minutes in the randomized part of the study. The results were similar considering the whole set of pediatric patients exposed to TachoSil (17/20 [85%]) (see Table 9). No statistical testing was performed of the difference between the two groups due to the small sample size. Seven patients in the TachoSil group (88%) and seven patients in the comparator group (78%) achieved hemostasis within five minutes (see Table 9).
Table 9. Achievement of Hemostasis of Pediatric Patients Undergoing Hepatic Surgery, Intent-To-Treat Population/Safety Population | |||
Treatment | Total number ofachieved hemostasis | Percentageof patients | Exact[95% CI] |
Hemostasis at 3 min | |||
TachoSil (n=8) | 7 | 88% | [47.3, 99.7] |
Comparator * (n=9) | 4 | 44% | [13.7, 78.8] |
Hemostasis at 5 min | |||
TachoSil (n=8) | 7 | 88% | [47.3, 99.7] |
Comparator * (n=9) | 7 | 78% | [40.0, 97.2] |
All TachoSil Patients † | |||
Hemostasis at 3 min | 17 | 85% | [62.1, 96.8] |
TachoSil (n=20) | |||
Hemostasis at 5 min | 19 | 95% | [75.1, 99.9] |
TachoSil (n=20) | |||
In another clinical study, 16 pediatric patients were included in a prospective, multi-center, uncontrolled, study where TachoSil was used in connection with resection of the liver with or without segmental liver transplantation.
The analysis of the efficacy parameter, time to hemostasis, showed that 13 of 16 patients achieved hemostasis within three minutes after application of TachoSil. One patient obtained hemostasis eight minutes after treatment application and two subjects failed to achieve satisfactory hemostasis within 10 minutes, which necessitated alternative hemostatic measures.
The estimated proportion of patients achieving hemostasis within three minutes was 81%, which is considered similar to results seen in the randomized controlled study.
16 HOW SUPPLIED/STORAGE AND HANDLING
Each TachoSil patch is packaged individually in a tray with lidding. This is placed in an outer pouch with a desiccant bag and packaged into a folding carton.
TachoSil is supplied in the following pack sizes:
| (NDC 0338-8701-01) |
| (NDC 0338-8702-02) |
Storage
•Use TachoSil before expiration date indicated on the package.
•Store unopened packages of TachoSil between 2ºC and 25ºC. TachoSil does not require refrigeration. Do not freeze.
•Do not use if package is opened or damaged.
17 PATIENT COUNSELING INFORMATION
- •
- Because TachoSil may cause the formation of clots in blood vessels if exposed intravascularly, advise patients to consult their physician if they experience chest pain, shortness of breath or difficulty speaking or swallowing, or leg tenderness or swelling [see Warnings and Precautions (5.1)].
- •
- Instruct patients to consult their physician if symptoms of B19 virus infection appear (fever, drowsiness and chills) followed about two weeks later by a rash and joint pain. Parvovirus B19 most seriously affects pregnant women (fetal infection); immune-compromised individuals or individuals with an increased erythropoiesis (e.g., hemolytic anemia) [see Warnings and Precautions (5.7)].
- •
- Advise patients that, because TachoSil is made from human blood, it may carry a risk of transmitting infectious agents (e.g., viruses), and theoretically, the Creutzfeldt-Jakob (CJD) agent [see Warnings and Precautions (5.7)].
Distributed by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Manufactured by:
Takeda Austria GmbH
St. Peter Strasse 25
4020 Linz, Austria
U.S. License No. 2294
TachoSil is a registered trademark licensed to Corza Medical GmbH
All other trademarks are the property of their respective owners.
TAC272 R5
PRINCIPAL DISPLAY PANEL — 1 Patch Blister Pack Pouch Carton — NDC 0338-8701-01
NDC 0338-8701-01
Fibrin
Sealant Patch
TachoSil®
3.7 inch x 1.9 inch
(9.5 cm x 4.8 cm)
Contents: 1 absorbable fibrin sealant patch
Single use only
Topical use only
Do not use intravascularly
Store at 2°C to 25°C (36°F to 77°F)
Do not freeze
Directions for use: See package insert
Do not use if package is opened or damaged
Use immediately once the foil pouch is opened
Do not resterilize
Dispose of any unused product or waste materialin accordance with local requirements
Rx Only
Product Code 1144922
Baxter
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