RECOTHROM

RECOTHROM- thrombin topical recombinant
Baxter Healthcare Corporation

1 INDICATIONS AND USAGE

RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age.

RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.

2 DOSAGE AND ADMINISTRATION

For topical use only. DO NOT INJECT.

2.1 Reconstitution of RECOTHROM Thrombin

The volume of reconstituted RECOTHROM thrombin required will vary depending on the size and number of bleeding sites to be treated and the method of application.

Inspect the integrity of the RECOTHROM package and contents. Do not use if the packaging or contents have been damaged or opened.

Reconstitute the lyophilized powder using the supplied diluent. Use aseptic technique when handling vials and syringes.

5000-unit RECOTHROM Thrombin Reconstitution

Units used herein represent international units of potency determined using a reference standard that has been calibrated against the World Health Organization Second International Standard for Thrombin.

1.
Remove flip-off cap from the top of the RECOTHROM vial.
2.
Attach the needle-free transfer device and snap it into place on the vial by placing the vial on a flat surface and attaching the transfer device straight into the center of the vial stopper.
3.
Attach the prefilled diluent syringe to the needle-free transfer device.
4.
Inject the 5 mL of diluent from the syringe into the product vial. Keep the syringe plunger depressed.
5.
DO NOT reuse the diluent syringe for transfer of the reconstituted product. Remove and discard the diluent syringe.
6.
Gently swirl and invert the product vial until the powder is completely dissolved. Avoid excessive agitation. The powder should dissolve in less than one minute at room temperature.
7.
Apply the pre-printed “DO NOT INJECT” label to the sterile, empty transfer syringe provided, then draw up the RECOTHROM solution.

20,000-unit RECOTHROM Thrombin Reconstitution

1.
Remove the flip-off cap from the top of the RECOTHROM vial and the diluent vial.
2.
Attach a needle-free transfer device (one each) to the RECOTHROM and diluent vials and snap them into place by placing the vial on a flat surface and attaching the transfer device straight into the center of the vial stopper.
3.
Open the sterile, empty 20-mL syringe package.
4.
Attach the 20-mL syringe to the needle-free transfer device on the diluent vial (injection of air into the diluent vial may facilitate withdrawal of the diluent).
5.
Draw up 20 mL of diluent from the vial into the syringe.
6.
Remove the diluent-filled syringe from the diluent vial and attach it to the transfer device on the RECOTHROM vial.
7.
Transfer the 20 mL of diluent from the syringe into the RECOTHROM vial; the vacuum in the vial facilitates transfer.
8.
Leave the syringe attached and gently swirl and invert the RECOTHROM vial until the powder is completely dissolved. Avoid excessive agitation. The powder should dissolve in less than one minute at room temperature.
9.
Apply the pre-printed ‘DO NOT INJECT’ label to the syringe. Draw up the RECOTHROM solution.

2.2 Application Techniques

Topically apply RECOTHROM thrombin solution directly or in conjunction with absorbable gelatin sponge onto the bleeding site. DO NOT INJECT.

The amount required depends upon the area of tissue to be treated and the method of application.

Vials are for single use only. Discard unused contents.

Use with Absorbable Gelatin Sponge

Refer to the absorbable gelatin sponge labeling for safety information and instructions on appropriate use.

1.
Transfer solution from syringe to a sterile bowl or basin.
2.
Place the desired size pieces of the absorbable gelatin sponge into the bowl containing reconstituted RECOTHROM to completely saturate the sponge(s).
3.
Remove the saturated sponge(s) and squeeze gently to remove excess RECOTHROM.
4.
Apply the sponge to the bleeding site in a single layer.

Use with RECOTHROM Thrombin Spray Applicator Kit

1.
Hold the outer sealed tray, peel back the lid, and aseptically transfer the inner sealed sterile tray to the sterile field.
2.
Open the inner tray seal and use the sterile bowl as the receptacle for reconstituted RECOTHROM solution.
3.
Refer to Spray Applicator Kit instructions for spray pump and syringe spray assembly and use.

Use in conjunction with FLOSEAL NT Hemostatic Matrix, 5mL

1.
5000-unit RECOTHROM may be used with FLOSEAL NT Hemostatic Matrix, 5mL according to the FLOSEAL NT Hemostatic Matrix, 5mL instructions for use (IFU).

3 DOSAGE FORMS AND STRENGTHS

RECOTHROM thrombin is available as a sterile lyophilized powder in 5000- and 20,000-unit single-use vials. When reconstituted with the sterile 0.9% sodium chloride, USP provided, the powder yields a solution containing 1000 units/mL of Thrombin topical (Recombinant).

4 CONTRAINDICATIONS

Do not inject directly into the circulatory system.
Do not use for the treatment of massive or brisk arterial bleeding.
Do not administer to patients with a history of hypersensitivity to RECOTHROM thrombin or any components of RECOTHROM.
Do not use in patients with known hypersensitivity to hamster proteins.

5 WARNINGS AND PRECAUTIONS

5.1 Thrombosis

RECOTHROM thrombin may cause thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT.

5.2 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, may occur.

RECOTHROM thrombin is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins [see Contraindications (4) and Description (11)].

6 ADVERSE REACTIONS

Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM thrombin in all completed clinical trials (N=644) [see Warnings and Precautions (5.1)].

Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin [see Adverse Reactions (6.2)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical trials have been performed with RECOTHROM thrombin applied with absorbable gelatin sponge and applied with a spray applicator. A total of 644 patients were exposed to RECOTHROM in these studies.

RECOTHROM Thrombin Used in Conjunction with Absorbable Gelatin Sponge

Four hundred eleven (411) patients were treated in a randomized, double-blind, controlled trial that compared RECOTHROM to bovine thrombin. Both thrombins were applied with a gelatin sponge in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access.1 The incidence of thromboembolic adverse reactions was similar between the RECOTHROM and bovine thrombin treatment groups (see Table 1).

Table 1: Incidence of Adverse Reactions with RECOTHROM Thrombin and Bovine Thrombin
*
THROMBIN-JMI Thrombin, Topical (Bovine)

Adverse Reaction Category

RECOTHROM

(N=205)

n (%)

Bovine Thrombin *

(N=206)

n (%)

Thromboembolic events

11 (5%)

12 (6%)

In an open-label, single-group trial (N=209), patients with documented or highly likely prior exposure to bovine thrombin within the previous three years were treated with RECOTHROM when undergoing surgeries (spinal, peripheral arterial bypass, or arteriovenous graft formation for hemodialysis access).2 The incidence of thromboembolic adverse reactions in this study was 9%.

In an open-label, single-group trial of re-exposure to RECOTHROM (N=31), patients with documented prior exposure to RECOTHROM were treated with RECOTHROM during surgery (spinal, peripheral arterial bypass, arteriovenous graft formation, or other procedures).3 The incidence of thromboembolic adverse reactions in this study was 3%.

In other randomized, double-blind trials across a range of surgical settings (N=130; spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access), the safety of RECOTHROM (n=88 patients) was compared to placebo (RECOTHROM excipients reconstituted with sterile 0.9% sodium chloride, USP) (n=42 patients). The incidence of thromboembolic adverse reactions in this study was 5% for RECOTHROM and 12% for placebo.

RECOTHROM Thrombin Applied with Spray Applicator

RECOTHROM was applied with a spray applicator in two open-label clinical trials: a single-group trial in adult and pediatric burn patients (N=72; ≤16 years of age, (n=4) and ≥17 years of age, (n=68)) treated with RECOTHROM applied to the wound excision site prior to autologous skin grafting4 ; and in a single-group trial in pediatric patients (one month to 17 years of age) undergoing synchronous burn wound excision and autologous skin grafting (N=30; ≤16 years of age, (n=26); ≥17 years of age, (n=4)).5 In the first study, the incidence of thromboembolic adverse reactions was 1%. In the second study, there were no reported thromboembolic adverse reactions [see Use in Specific Populations (8.4)].

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