Mallinckrodt Hemostat SolutionsMallinckrodt Hemostat Solutions

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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.

Room temperature storage2

No refrigeration needed; do not freeze

Available in 2 vial sizes2

Upon reconstitution, RECOTHROM powder should dissolve in less than 1 minute2

5000 unit* RECOTHROM Reconstitution Kit2

5000-unit Reconstitution Steps 1-2: Remove cap & attach needle-free transfer device
  1. Use aseptic technique when handling the vials and syringes. Remove flip-off cap from the top of the RECOTHROM vial.
  2. Attach the needle-free transfer device: Snap it into place on the vial by placing the vial flat on a surface and attaching the transfer device straight into the center of the vial stopper.
5000-unit Reconstitution Steps 3-5: Inject diluent from syringe into product vial
  1. Attach the prefilled diluent syringe to the needle-free transfer device.
  2. Inject the 5 mL of diluent from the syringe into the product vial. Keep the syringe plunger depressed.
  3. DO NOT reuse the diluent syringe for transfer of the reconstituted product. Remove and discard the diluent syringe.
5000-unit Reconstitution Step 6: Gently swirl & invert product vial
  1. Gently swirl and invert the product vial until the powder is completely dissolved (avoid excessive agitation). The powder should dissolve in less than 1 minute at room temperature.
5000-unit Reconstitution Step 7a: Apply 'DO NOT INJECT' label. 5000-unit Reconstitution Step 7b: Draw up the RECOTHROM solution
  1. Apply the preprinted “DO NOT INJECT” label to the sterile, empty transfer syringe provided, and then draw up the RECOTHROM solution.

    RECOTHROM is now ready to be transferred to a receptacle in a sterile field.

    For topical use only. DO NOT INJECT.
    No RECOTHROM Kit components contain latex.

    *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.

20,000 unit RECOTHROM Reconstitution Kit2

20,000-unit Reconstitution Steps 1-2: Attach a needle-free transfer device to each vial
  1. Use aseptic technique when handling the vials and syringes. Remove the flip-off cap from the top of the RECOTHROM vial and the diluent vial.
  2. Attach one needle-free transfer device to the RECOTHROM vial and one to the diluent vial: Snap them into place on the vials by placing the vials flat on a surface and attaching the transfer devices straight into the center of the vial stoppers.
20,000-unit Reconstitution Step 3: Attach 'DO NOT INJECT' label to syringe
  1. Open the sterile, empty 20 mL syringe package, and attach the preprinted “DO NOT INJECT” label to the syringe (see underside of box top for label).
20,000-unit Reconstitution Step 4: Attach 20 mL syringe to the needle-free transfer device on the diluent vial. 20,000-unit Reconstitution Step 5: Draw up 20 mL of diluent
  1. Attach the labeled 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).
  2. Draw up 20 mL of diluent from the vial into the syringe.
20,000-unit Reconstitution Steps 6-7:Transfer the 20 mL of diluent into the RECOTHROM vial
  1. Remove the diluent-filled syringe from the diluent vial, and attach it to the transfer device on the RECOTHROM vial.
  2. Transfer the 20 mL of diluent from the syringe into the RECOTHROM vial; the vacuum in the vial facilitates transfer.
20,000-unit Reconstitution Step 8: Gently swirl and invert product vial
  1. Leave the syringe attached. Gently swirl and invert the product vial until the powder is completely dissolved (avoid excessive agitation). The powder should dissolve in less than 1 minute at room temperature.
20,000-unit Reconstitution Step 9: Draw up the RECOTHROM solution
  1. With the same syringe, draw up the RECOTHROM solution.

    RECOTHROM is now ready to be transferred to a receptacle in a sterile field.

    For topical use only. DO NOT INJECT.
    No RECOTHROM Kit components contain latex.

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.

Important Risk Information

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 or any components of RECOTHROM.
  • Do not use in patients with known hypersensitivity to hamster proteins.

Warnings and Precautions

  • For topical use only. DO NOT INJECT.
  • RECOTHROM may cause thrombosis if it enters the circulatory system.
  • Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins.

Adverse Reactions

  • Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM in all completed clinical trials.
  • Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin.

Use In Specific Populations

  • Pregnancy Category C. RECOTHROM should be given to a pregnant woman only if clearly needed.
  • Pediatric Use: Safety and efficacy have not been established in neonates.
  • Geriatric Use: Of 644 patients in clinical studies of RECOTHROM, 36% (n=232/644) were ≥65 years old and 15% (n=95/644) were ≥75 years old. No differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the Full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Mallinckrodt completes acquisition of three commercial-stage, global specialty hemostasis brands from The Medicines Company [news release]. Chesterfield, UK: Mallinckrodt Pharmaceuticals; February 1, 2016. http://www.mallinckrodt.com/about/news-and-media/2134017. Accessed April 6, 2016. 2. RECOTHROM [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products Inc; 2016.