TachoSil: Package Insert and Label Information (Page 3 of 3)

14.2 Hepatic

A randomized, open-label, parallel group, multi-center trial comparing TachoSil with comparator was conducted to evaluate TachoSil for the secondary treatment of local bleeding in patients undergoing hepatic surgery.

A total of 114 patients were randomized to treatment with TachoSil and 110 patients were randomized to treatment with comparator. A similar proportion of male patients and female patients were randomly assigned in the trial (53% and 47%, respectively). The mean (SD) age of patients was 58.1 (13.95) years and in both treatment groups approximately 30% of the patients were above 65 years. The majority of patients were White/Caucasian (80%) and the most common ethnicity was non-Hispanic/non-Latino (88%).

A larger proportion of patients in the TachoSil treatment group (81%) than in the comparator treatment group (50%) achieved hemostasis within the first three minutes after treatment application. The primary analysis of the proportion of patients who achieved hemostasis within three minutes showed a statistically significant difference between treatment groups in favor of TachoSil (p<0.001) and obtained a clinical relevant difference between the two groups defined from the estimated odds ratio (see Table 8).

With respect to one of the two secondary endpoints, 108 (95%) patients in the TachoSil group and 84 (76%) patients in the comparator group achieved hemostasis within five minutes in which the secondary analysis also showed a statistically significant difference between the group in favor of TachoSil (p<0.001, multiplicity adjusted) (see Table 8).

*
Hochberg’s adjustment for multiplicity
Hemostatic fleece material made of oxidized cellulose polymer
Analyzed by a log rank test for equality over treatments. Patients who did not achieve hemostasis after 10 minutes were censored in the analysis.

Table 8. Efficacy Results in Hepatic Surgery, by Treatment, Intent-To-Treat Population

Treatment

Total number of patientswho achieved hemostasis

Percentage of patientswho achieved hemostasis

Odds ratio[95% CI]

p-value *

Hemostasis at 3 min

TachoSil (n=114)

92

81%

4.87[2.55; 9.29]

<0.001

Comparator (n=110)

55

50%

Hemostasis at 5 min

TachoSil (n=114)

108

95%

6.24[2.39;16.30]

<0.001

Comparator (n=110)

84

76%

Time to hemostasis

<0.001

TachoSil (n=114)

Comparator (n=110)

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).

*
Hemostatic fleece material made of oxidized cellulose polymer
Safety analysis set

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:

Package with 1 patch of 3.7 inch x 1.9 inch(9.5 cm x 4.8 cm)

(NDC 0338-8701-01)

Package with 2 patches of 1.9 inch x 1.9 inch(4.8 cm x 4.8 cm)

(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. 1894

TachoSil is a trademark of Takeda AS registered with the U.S. Patent and Trademark Office.

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

PRINCIPAL DISPLAY PANEL -- 1 Patch Blister Pack Pouch Carton -- NDC 0338-8701-01
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2 Patch Blister Pack Pouch Carton

NDC 0338-8702-02

Fibrin
Sealant Patch
TachoSil®

1.9 inch x 1.9 inch
(4.8 cm x 4.8 cm)

Contents: 2 absorbable fibrin sealant patches

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 1144923

Baxter

PRINCIPAL DISPLAY PANEL -- 2 Patch Blister Pack Pouch Carton
(click image for full-size original)
TACHOSIL thrombin human and fibrinogen patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-8701
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN THROMBIN (HUMAN THROMBIN) HUMAN THROMBIN 2.0 [USP’U]
FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 5.5 mg
Inactive Ingredients
Ingredient Name Strength
EQUINE COLLAGEN
ALBUMIN HUMAN
RIBOFLAVIN
SODIUM CHLORIDE
SODIUM CITRATE, UNSPECIFIED FORM
ARGININE HYDROCHLORIDE
Product Characteristics
Color YELLOW (active side) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-8701-01 1 POUCH in 1 CARTON contains a POUCH (0338-8701-00)
1 NDC:0338-8701-00 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0338-8701-01) and contains a BLISTER PACK
1 1 PATCH in 1 BLISTER PACK This package is contained within a POUCH (0338-8701-00) and a CARTON (0338-8701-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125351 04/05/2010
TACHOSIL thrombin human and fibrinogen patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-8702
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN THROMBIN (HUMAN THROMBIN) HUMAN THROMBIN 2.0 [USP’U]
FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 5.5 mg
Inactive Ingredients
Ingredient Name Strength
EQUINE COLLAGEN
ALBUMIN HUMAN
RIBOFLAVIN
SODIUM CHLORIDE
SODIUM CITRATE, UNSPECIFIED FORM
ARGININE HYDROCHLORIDE
Product Characteristics
Color YELLOW (active side) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-8702-02 2 POUCH in 1 CARTON contains a POUCH (0338-8702-00)
1 NDC:0338-8702-00 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0338-8702-02) and contains a BLISTER PACK
1 1 PATCH in 1 BLISTER PACK This package is contained within a POUCH (0338-8702-00) and a CARTON (0338-8702-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125351 04/05/2010
Labeler — Baxter Healthcare Corporation (005083209)

Revised: 02/2020 Baxter Healthcare Corporation

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