RECOTHROM (Page 3 of 3)

14 CLINICAL STUDIES

RECOTHROM thrombin was evaluated in a randomized, double-blind comparative clinical trial to bovine

thrombin. Each thrombin was topically applied to bleeding sites with an absorbable gelatin sponge at a nominal concentration of 1000 units/mL.1 Patients (N=411) were a heterogeneous surgical population undergoing surgery in one of four surgical settings: spinal surgery (n=122, 30%), hepatic resection (n=125, 30%), peripheral arterial bypass surgery (n=88, 21%), and arteriovenous graft formation for hemodialysis access (n=76, 18%). Patients with prior heparin-induced thrombocytopenia were excluded. Patient ages ranged from 21 to 89 years, gender was 53% male and 47% female, and the distribution by race was 68% white, 18% black or African American, and 14% other. The distribution of these characteristics was similar in both the RECOTHROM and bovine thrombin treatment groups.

The objectives of the study were to evaluate the comparative efficacy, safety, and immunogenicity of RECOTHROM and bovine thrombin in combination with an absorbable gelatin sponge as adjuncts to hemostasis in surgery. Efficacy was evaluated by the incidence of hemostasis within 10 minutes. Bleeding appropriate for evaluation was defined as mild to moderate bleeding, either on its own or remaining after brisk bleeding was controlled by standard surgical modalities. Although multiple bleeding sites could be treated, only one bleeding site per patient was selected to determine effectiveness.

Table 2 summarizes the incidence of hemostasis within 10 minutes for each treatment for the 401
efficacy evaluable patients. The incidence of hemostasis within 10 minutes was comparable for the RECOTHROM and bovine thrombin groups.

Table 2: Hemostasis Within 10 Minutes *
*
Evaluation of hemostasis at ≤ 10 minutes for patients treated at 1 of 4 primary TTH bleeding site types: epidural venous plexus, hepatic resection site, peripheral arterial bypass proximal anastomosis, and arteriovenous graft arterial anastomosis.
THROMBIN-JMI Thrombin, Topical (Bovine)

RECOTHROM

(N=198)

(%)

Bovine Thrombin

(N=203)

(%)

Overall

95%

95%

Spinal surgery

98%

98%

Hepatic resection

98%

97%

Peripheral arterial bypass

85%

86%

Arteriovenous graft formation

97%

97%

The percentage of patients achieving hemostasis at 1.5, 3, 6, and 10 minutes is listed in Table 3.

Table 3: Cumulative Incidence of Hemostasis Over Time
*
THROMBIN-JMI Thrombin, Topical (Bovine)

Time (Minutes)

RECOTHROM

(N=198)

(%)

Bovine Thrombin *

(N=203)

(%)

1.5

48%

46%

3

81%

72%

6

92%

88%

10

95%

95%

15 REFERENCES

1.
Chapman WC, Singla N, Genyk Y, et al. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007;205(2):256-265.
2.
Singla NK, Ballard JL, Moneta G, et al. A phase 3b open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis. J Am Coll Surg. 2009;209(1):68-74.
3.
Singla NK, Gasparis AP, Ballard JL, et al. Immunogenicity and safety of re-exposure to recombinant human thrombin in surgical hemostasis. J Am Coll Surg. 2011;213(6):722-727.
4.
Greenhalgh DG, Gamelli RL, Collins J, et al. Recombinant thrombin: safety and immunogenicity in burn wound excision and grafting. J Burn Care Res. 2009;30(3):371-379.
5.
Foster KN, Mullins RF, Greenhalgh DG, et al. Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision. J Ped Surg. 2011;46(10):1992-1999.

16 HOW SUPPLIED/STORAGE AND HANDLING

RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:

NDC 0338-0322-01
A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.

NDC 0338-0326-01
A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.

NDC 0338-0330-01
The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit
containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.

No RECOTHROM kit components contain latex.

Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze.

Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.

17 PATIENT COUNSELING INFORMATION

Because topical thrombin may cause the formation of clots in blood vessels if absorbed systemically, advise patients to consult their physician if they experience leg tenderness or swelling, chest pain, shortness of breath, or difficulty speaking or swallowing [see Warnings and Precautions (5.1)].

Baxter and Recothrom are registered trademarks of Baxter International Inc.
Thrombin-JMI is a registered trademark of King Pharmaceuticals Research and Development, LLC.

Manufactured for:
Baxter Healthcare Corporation Deerfield, IL 60015 USA

US License No. 0140

07-19-00-2809

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Recothrom Representative Carton Label 0338-0322-01 1 of 3
(click image for full-size original)
Recothrom Representative Carton Label 0338-0322-01 2 of 3
(click image for full-size original)
Recothrom Representative Carton Label 0338-0322-01 3 of 3
(click image for full-size original)

Carton Label

PS
5,000 units

NDC: 0338-0322-01

FOR TOPICAL USE ONLY — DO NOT INJECT

Baxter Logo

RECOTHROM
Thrombin topical
(Recombinant)

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
US License No. 0140
Made in Italy

Rx only

Store at 2-25°C (36-77°F).
Do not freeze.
See package insert
Full Prescribing Information.

No components
contain latex.
No preservative.

5,000 units
NDC: 0338-0322-01

FOR TOPICAL USE ONLY — DO NOT INJECT

Baxter Logo

RECOTHROM
Thrombin topical
(Recombinant)

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
US License No. 0140
Made in Italy

FPO

FPO

LOT: XXXXXXX
EXP: MMYYYY

5,000 units
Rx only

CONTENTS:

• One single-use vial containing 5,000
International Units of sterile Thrombin
topical (Recombinant)

• One 5-mL prefilled diluent syringe
(containing sterile 0.9% sodium chloride
injection, USP)

• One sterile needle-free transfer device

• One sterile 5-mL empty syringe for transfer

• One syringe label

PS

5,000 units
NDC: 0338-0322-01

FOR TOPICAL USE ONLY — DO NOT INJECT

Baxter Logo

RECOTHROM
Thrombin topical
(Recombinant)

Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140
Baxter and Recothrom are registered trademarks of Baxter International Inc.
Made in Italy

Rx only

CONTENTS:

• One single-use vial containing 5,000
International Units of sterile Thrombin
topical (Recombinant)

• One 5-mL prefilled diluent syringe
(containing sterile 0.9% sodium chloride
injection, USP)

• One sterile needle-free transfer device

• One sterile 5-mL empty syringe for transfer

• One syringe label

FPO

5,000 units
Rx only
Store at 2-25°C (36-77°F).
Do not freeze.
See package insert Full Prescribing Information.

Baxter Logo

07-01-00-0536

Recothrom Representative Carton Label 0338-0326-01 1 of 3
(click image for full-size original)
Recothrom Representative Carton Label 0338-0326-01 2 of 3
(click image for full-size original)
Recothrom Representative Carton Label 0338-0326-01 3 of 3
(click image for full-size original)

Carton Label

20,000 units NDC: 0338-0326-01

FOR TOPICAL USE ONLY — DO NOT INJECT

Baxter Logo

RECOTHROM
Thrombin topical
(Recombinant)

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
US License No. 0140
Made in Italy

Rx only
Store at 2-25°C (36-77°F).
Do not freeze.
See package insert
Full Prescribing Information.
No components
contain latex.
No preservative.

Baxter and Recothrom are registered trademarks of Baxter International Inc.

20,000 units
NDC: 0338-0326-01

FOR TOPICAL USE ONLY — DO NOT INJECT

Baxter Logo

RECOTHROM
Thrombin topical
(Recombinant)

Rx only
Store at 2-25°C
(36-77°F).
Do not freeze.
See package insert
Full Prescribing Information.
Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
US License No. 0140
Made in Italy

FPO

FPO

LOT: XXXXXXX
EXP: MMYYYY

20,000 units
NDC: 0338-0326-01

Rx only
Store at 2-25°C
(36-77°F).
Do not freeze.
See package insert
Full Prescribing Information.

CONTENTS:

• One single-use vial containing 20,000
International Units of sterile Thrombin
topical (Recombinant)

• One vial diluent (containing 20-mL sterile
0.9% sodium chloride injection, USP)

• Two sterile needle-free transfer devices

• One sterile 20-mL empty syringe for transfer

• One syringe label

20,000 units
NDC: 0338-0326-01

FOR TOPICAL USE ONLY — DO NOT INJECT

Baxter Logo

RECOTHROM
Thrombin topical
(Recombinant)

Rx only
Store at 2-25°C
(36-77°F).
Do not freeze.
See package insert
Full Prescribing Information.

CONTENTS:

• One single-use vial containing 20,000
International Units of sterile Thrombin
topical (Recombinant)

• One vial diluent (containing 20-mL sterile
0.9% sodium chloride injection, USP)

• Two sterile needle-free transfer devices

• One sterile 20-mL empty syringe for transfer

• One syringe label

FPO

20,000 units
NDC: 0338-0326-01

FOR TOPICAL USE ONLY — DO NOT INJECT

Baxter Logo

RECOTHROM
Thrombin topical
(Recombinant)

Rx only
Store at 2-25°C
(36-77°F).
Do not freeze.
See package insert Full Prescribing Information.

07-01-00-0538

Recothrom Representative Carton Label 0338-0330-01 1 of 2
(click image for full-size original)
Recothrom Representative Carton Label 0338-0330-01 2 of 2
(click image for full-size original)

Carton Label

20,000 units NDC: 0338-0330-01

FOR TOPICAL USE ONLY — DO NOT INJECT

RECOTHROM
Thrombin topical
(Recombinant)

20,000 units

WITH SPRAY APPLICATOR KIT

Rx only
Store at 2-25°C (36-77°F).
Do not freeze.
See package insert
Full Prescribing Information.
No components contain latex.
No preservative.

RECOTHROM CONTENTS:
• One single-use vial containing 20,000 International
Units of sterile Thrombin topical (Recombinant)

• One vial diluent (containing 20-mL sterile 0.9%
sodium chloride injection, USP)

• Two sterile needle-free transfer devices

• One sterile 20-mL empty syringe for transfer

• One syringe label

SPRAY APPLICATOR CONTENTS:

• One spray pump

• One spray bottle

• One syringe spray tip

• One 20-mL syringe

• One 30-mL bowl

• Two blank labels

• Instructions for use

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 uSA
US License No. 0140
Made in Italy

Baxter Logo
Baxter and Recothrom are registered trademarks
of Baxter International Inc.

20,000 units
NDC: 0338-0330-01

FOR TOPICAL USE ONLY — DO NOT INJECT

RECOTHROM
Thrombin topical
(Recombinant)

20,000 units

WITH SPRAY APPLICATOR KIT

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 uSA
US License No. 0140
Made in Italy

Baxter Logo

07-03-00-0574

FPO

20,000 units
NDC: 0338-0330-01

FOR TOPICAL USE ONLY — DO NOT INJECT

RECOTHROM
Thrombin topical
(Recombinant)

20,000 units

WITH SPRAY APPLICATOR KIT

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 uSA
US License No. 0140
Made in Italy

Baxter Logo

07-03-00-0574

20,000 units
NDC: 0338-0330-01

FOR TOPICAL USE ONLY — DO NOT INJECT

RECOTHROM
Thrombin topical
(Recombinant)

20,000 units

WITH SPRAY APPLICATOR KIT

Rx only
Store at 2-25°C (36-77°F).
Do not freeze.
See package insert
Full Prescribing Information.
No components contain latex.
No preservative.

RECOTHROM CONTENTS:
• One single-use vial containing 20,000 International
Units of sterile Thrombin topical (Recombinant)

• One vial diluent (containing 20-mL sterile 0.9%
sodium chloride injection, USP)

• Two sterile needle-free transfer devices

• One sterile 20-mL empty syringe for transfer

• One syringe label

SPRAY APPLICATOR CONTENTS:

• One spray pump

• One spray bottle

• One syringe spray tip

• One 20-mL syringe

• One 30-mL bowl

• Two blank labels

• Instructions for use

FPO

FPO

LOT: XXXXXXX
EXP: MMYYYY

20,000 units
NDC: 0338-0330-01

Baxter Logo

RECOTHROM
Thrombin topical
(Recombinant)

20,000 units

WITH SPRAY APPLICATOR KIT

FOR TOPICAL USE ONLY — DO NOT INJECT

Rx only
Store at 2-25°C (36-77°F).
Do not freeze.
See package insert
Full Prescribing Information.
No components contain latex.
No preservative.

RECOTHROM CONTENTS:
• One single-use vial containing 20,000 International
Units of sterile Thrombin topical (Recombinant)

• One vial diluent (containing 20-mL sterile 0.9%sodium chloride injection, USP)

• Two sterile needle-free transfer devices

• One sterile 20-mL empty syringe for transfer

• One syringe label

SPRAY APPLICATOR CONTENTS:

• One spray pump

• One spray bottle

• One syringe spray tip

• One 20-mL syringe

• One 30-mL bowl

• Two blank labels

• Instructions for use

RECOTHROM thrombin topical recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0322
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0322-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 5 mL
Part 2 1 SYRINGE 5 mL
Part 1 of 2
RECOTHROM thrombin topical recombinant powder, for solution
Product Information
Item Code (Source) NDC:0338-0324
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THROMBIN ALFA (THROMBIN ALFA) THROMBIN ALFA 1000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SUCROSE
SODIUM CHLORIDE
POLYETHYLENE GLYCOL 3350
HISTIDINE
CALCIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0324-01 5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 01/29/2008
Part 2 of 2
SODIUM CHLORIDE normal saline solution
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 5 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 01/29/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 01/29/2008
RECOTHROM thrombin topical recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0326
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0326-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 20 mL
Part 2 1 SYRINGE 20 mL
Part 1 of 2
RECOTHROM thrombin topical recombinant powder, for solution
Product Information
Item Code (Source) NDC:0338-0328
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THROMBIN ALFA (THROMBIN ALFA) THROMBIN ALFA 1000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SUCROSE
SODIUM CHLORIDE
POLYETHYLENE GLYCOL 3350
HISTIDINE
CALCIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0328-01 20 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 06/09/2008
Part 2 of 2
SODIUM CHLORIDE sodium chloride solution
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 20 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 06/09/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 06/09/2008
RECOTHROM thrombin topical recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0330
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0330-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 20 mL
Part 2 1 VIAL 20 mL
Part 1 of 2
RECOTHROM thrombin topical recombinant powder, for solution
Product Information
Item Code (Source) NDC:0338-0328
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THROMBIN ALFA (THROMBIN ALFA) THROMBIN ALFA 1000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SUCROSE
SODIUM CHLORIDE
POLYETHYLENE GLYCOL 3350
HISTIDINE
CALCIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0328-01 20 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 06/09/2008
Part 2 of 2
SODIUM CHLORIDE sodium chloride solution
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 20 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 06/09/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125248 06/09/2008
Labeler — Baxter Healthcare Corporation (005083209)

Revised: 12/2020 Baxter Healthcare Corporation

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