Mallinckrodt Hemostat SolutionsMallinckrodt Hemostat Solutions

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Indications and Usage

RAPLIXA® (Fibrin sealant (human)) for topical use is a fibrin sealant indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and may be applied directly or using the RaplixaSprayTM device.

Appropriate for a variety of challenging bleeding situations

RAPLIXA is effective in treating:

3 ways to apply1

RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and can be:

View application instructions
  1. Sprinkled directly onto the bleeding site.

Direct application of RAPLIXA with absorbable gelatin sponge (USP)1

Please refer to absorbable gelatin sponge (USP) labeling for complete instructions for use.

  1. Open the pouch and remove the RAPLIXA vial following standard sterile technique to ensure that the vial and surgical field remain sterile.
  2. Check that the powder is in the bottom of the vial. Remove the flip-off top, leaving the stopper in place until immediately prior to use.
  3. Prepare sterile gelatin sponge by trimming it to an appropriate size for the bleeding site.
  4. Remove stopper and gently sprinkle a uniform, thin coating of RAPLIXA onto the bleeding site. Using sterile gauze, apply gentle pressure with gelatin sponge.
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View application instructions
  1. Sprinkled onto an absorbable gelatin sponge.

Direct application of RAPLIXA with absorbable gelatin sponge (USP)1

Please refer to absorbable gelatin sponge (USP) labeling for complete instructions for use.

  1. Open the pouch and remove the RAPLIXA vial following standard sterile technique to ensure that the vial and surgical field remain sterile.
  2. Check that the powder is in the bottom of the vial. Remove the flip-off top, leaving the stopper in place until immediately prior to use.
  3. Prepare sterile gelatin sponge by trimming it to an appropriate size for the bleeding site.
  4. Remove stopper and sprinkle a thin layer of RAPLIXA onto a prewetted gelatin sponge. Using sterile gauze, place the sponge onto the bleeding site and apply gentle pressure.
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View application instructions
  1. Sprayed using the RaplixaSprayTM device.

Preparation and application of RAPLIXA using the RaplixaSpray device with absorbable gelatin sponge (USP)

Please refer to the labeling for the RaplixaSpray device and the RaplixaReg™ regulators for complete Instructions for Use. Please refer to absorbable gelatin sponge (USP) labeling for complete instructions for use.1

Note: Connect one end of the filter to the device line in the sterile field before connecting the other end of the filter to the regulator.4

Attach vial
  1. Prepare the pressure regulator (medical air or CO2) according to the manufacturer’s instructions for use.1
    (Note: Always test the RaplixaSpray device prior to use.4)
  2. Open the pouch and remove the RAPLIXA vial following standard sterile technique to ensure that the vial and surgical field remain sterile.1
  3. Check that the powder is in the bottom of the vial. Remove the flip-off top, leaving the stopper in place until use.1
  4. Prepare sterile gelatin sponge by trimming it to an appropriate size for the bleeding site.1
  5. To attach the vial to the RaplixaSpray device, invert the device and place the upright vial into the gray rubber ring on the device, turn the device upright, and return the device to the sterile field until use.1
Activate air
  1. Activate air or gas flow.1
  2. Device is now ready for use. DO NOT push the operating button until ready for use.1
22psi
  1. Check that the pressure is 22 psi (1.5 bar) prior to turning on the regulator.1
Holding device
  1. Ensure the vial is kept within 45° of vertical at all times.1
  2. Hold nozzle at a minimum of 2 inches (or 5 cm) from the bleeding site.1
  3. Start application by gently pressing the operating button.1
Spray on wound Hand sponge
  1. Powder should cover the bleeding surface as a uniform, thin coating. Apply RAPLIXA within 10-60 seconds.1
  2. Immediately after RAPLIXA application, place a gelatin sponge, trimmed to the approximate size of the bleeding site, on top of the RAPLIXA powder. (The gelatin sponge may be used dry or moistened with sterile saline. A moistened sponge molds more easily to irregularly shaped and contoured bleeding areas.) Using sterile gauze, hold the gelatin sponge in place with manual pressure.1
Detach vial
  1. Hold the device upside down, and carefully remove the empty vial. If needed, attach the second vial (repeat steps 1-14). Use no more than 2 vials of RAPLIXA with the RaplixaSpray device.1
  2. To administer a third vial, open a new RaplixaSpray device (repeat steps 1-13). The maximum total dose of RAPLIXA per surgery is 3 g.1
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RaplixaSpray device

Complete Instructions for Use

For precise application of RAPLIXA over diffuse bleeding areas1

The RaplixaSpray device comes prepackaged with 2 detachable nozzles—1 rigid and 1 flexible.4

The RaplixaSpray device can be used with either the RaplixaReg™ CO2 regulator or the RaplixaReg™ air regulator to deliver RAPLIXA powder at a low pressure of 0.01 psi at tip of the device.1,5

Indications and Usage

RAPLIXA® (Fibrin sealant (human)) for topical use is a fibrin sealant indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and may be applied directly or using the RaplixaSprayTM device.

Important Risk Information

Contraindications

  • Do not apply intravascularly.
  • Do not use for the treatment of severe or brisk arterial bleeding.
  • Do not use in patients known to have anaphylactic or severe systemic reactions to human blood products.

Warnings and Precautions

  • For topical use only.
  • Life-threatening thromboembolic events may result from intravascular application of RAPLIXA.
  • Air or gas embolism has occurred with the use of spray devices employing pressure regulators to administer fibrin sealants.
  • Because the biological components of this product are made of human plasma, RAPLIXA may carry a risk of transmitting infectious agents, such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of infectious agent transmission.
  • Allergic type hypersensitivity reactions may occur. Signs of hypersensitivity reactions may include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.

Adverse Reactions

  • The most commonly reported adverse reactions (>5% subjects) were procedural pain, nausea, constipation, pyrexia, and hypotension.

Use In Specific Populations

  • Pregnancy: Animal reproduction studies have not been conducted with RAPLIXA. It is also not known whether RAPLIXA can cause fetal harm when administered to pregnant women or can affect reproductive capacity. RAPLIXA should be given to a pregnant woman only if clearly needed.
  • Breastfeeding: It is not known whether RAPLIXA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administering to a nursing woman.
  • Pediatric Use: Safety and effectiveness of RAPLIXA in pediatric patients has not been established.
  • Geriatric Use: Clinical trials included 207/566 subjects of 65 years of age or older who were treated with RAPLIXA. No differences in safety and efficacy were observed between elderly and younger patients.

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.

RaplixaSpray device

Intended Use

RaplixaSpray™ device is intended for the topical application of the hemostatic agent RAPLIXA via spraying with propellant gas to control delivery of powder onto the wound surface. The accessory, the flexible nozzle, is intended to enable the RaplixaSpray device to be used in difficult to reach areas.

Important Risk Information

Contraindications

  • Do not administer RAPLIXA intravascularly.
  • Do not use for the treatment of severe or brisk arterial bleeding.

WARNINGS

  • Only use the RaplixaSpray device with the RAPLIXA powder.
  • Only use the RaplixaSpray device with a RaplixaReg CO2 regulator.
  • Only use RaplixaSpray accessories. The use of accessories of other manufacturers is not permitted.
  • A RaplixaSpray device can be used with at most two vials. To administer a third vial, a new device must be opened. The maximum total dose per patient is 3 grams.
  • The RaplixaSpray device and accessory must be used within 1 hour of opening the device package.
  • RAPLIXA powder must be used within 1 hour of opening the vial.
  • Air or gas embolism can occur using air- or gas-pressurized sprayers to administer fibrin sealants. Operate the device according to the manufacturer’s instructions. Be sure to take appropriate measures to exclude these risks, by control of maximum pressure of 1.5 bar (22 psi) and at a minimum distance of 5 cm (2 inches). Do not touch the tip against the bleeding site. Do not bend the flexible nozzle more than 90 degrees.
  • Ensure the vial is kept within 45° of vertical at all times.
  • Do not cut the nozzle to length.
  • Be careful not to push the RaplixaSpray device operating button when handing the device to the surgeon.
  • Do not re-use the device. The RAPLIXA powder contains human blood-derived materials and might remain in the device after use. To prevent contamination the device or its accessory must not be reused.
  • Caution: There is the potential for powder loss from the nozzle tip during or after usage. Minor leakage/drop of powder from the nozzle tip can occur when transferring the device back to the table. After the blue button is released and application of RAPLIXA powder is stopped some minor powder is still present in the nozzle. A single occurrence of powder leakage during transfer of device after use during Phase 3 clinical trial was noticed. The hazard is trivial and the user may not even be aware of it.

Please see complete Instructions for Use 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. RAPLIXA [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products Inc; 2016. 2. Bochicchio GV, Gupta N, Porte RJ, et al. The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical Fibrocaps in intraoperative surgical hemostasis. J Am Coll Surg. 2015;220(1):70-81. 3. Data on file. Mallinckrodt Hospital Products, Inc. 4. RaplixaSpray, Raplixa Delivery Device [instructions for use]. The Netherlands: ProFibrix BV; ST-FC-2014-009, version 4. 5. Verhoef C, Singla N, Moneta G, et al. Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials. J Surg Res. 2015;194(2):679-687.