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.

Proven in a broad range of surgical settings

Phase 3 study: RAPLIXA achieved a median time to hemostasis of 1 to 2 minutes across 4 types of surgery1

Median time to hemostasis

RAPLIXA vs gelatin sponge alone: Median time to hemostasis (Bochicchio)

CI, confidence interval.
a P<0.001, from log-rank test.

Bochicchio et al: In a phase 3, international, multicenter, randomized, single-blind controlled trial, 721 adult patients undergoing spinal procedures (cervical, thoracic, or lumbar discectomy; corpectomy; laminectomy; or lateral or interbody fusion), hepatic resection (wedge or anatomic), vascular procedures (arteriovenous graft formation, arterial bypass, or carotid endarterectomy), or soft tissue dissection surgery (including, but not limited to, abdominoplasty, lower anterior resections, abdominal perineal resection, distal pancreatectomy, esophagectomy, skin graft donor site in burn patients, and mastectomy) with mild to moderate bleeding were treated at a single bleeding site with either RAPLIXA plus gelatin sponge or gelatin sponge alone.1,2

Phase 3 study: RAPLIXA demonstrated a higher probability of hemostasis at 5 minutes compared with gelatin sponge alone across 4 types of surgery1

Probability of hemostasis at 5 minutes1,3

RAPLIXA probability

CI, confidence interval.
a P values from Wald-based normal approximation of binomial with continuity correction.

Bochicchio et al: In a phase 3, international, multicenter, randomized, single-blind controlled trial, 721 adult patients undergoing spinal procedures (cervical, thoracic, or lumbar discectomy; corpectomy; laminectomy; or lateral or interbody fusion), hepatic resection (wedge or anatomic), vascular procedures (arteriovenous graft formation, arterial bypass, or carotid endarterectomy), or soft tissue dissection surgery (including, but not limited to, abdominoplasty, lower anterior resections, abdominal perineal resection, distal pancreatectomy, esophagectomy, skin graft donor site in burn patients, and mastectomy) with mild to moderate bleeding were treated at a single bleeding site with either RAPLIXA plus gelatin sponge or gelatin sponge alone.1,2

Effective in anticoagulated patients1,4

Exploratory subset analysis: RAPLIXA achieved a faster median time to hemostasis compared with gelatin sponge alone

Efficacy in patients on antiplatelets and/or anticoagulants4,a

RAPLIXA vs gelatin sponge alone: Median time to hemostasis (Bochicchio) table

CI, confidence interval; NE, not evaluable; TTH, time to hemostasis.
a Anticoagulants and antiplatelet agents were classified according to the World Health Organization Drug Reference List (March 2010 version), and patients were categorized by use of such medications that were ongoing or beginning on the day of the surgical procedure.
b From Cox regression model.
c P values from log-rank test.

Gupta et al: An exploratory analysis of the phase 3 trial was performed for a subset of 175 adult patients undergoing vascular procedures and receiving antiplatelet agents, anticoagulants, or both. Antiplatelet agents included adenosine diphosphate receptor inhibitors, cyclooxygenase inhibitors, gylcoprotein IIb/IIIb inhibitors (intravenous use only), and phosphodiesterase inhibitors. Anticoagulant agents included direct factor Xa inhibitors, synthetic pentasaccharide inhibitors of factor X, direct thrombin inhibitors, heparin, low-molecular-weight heparin, and vitamin K antagonists.1,4

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. 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. 2. RAPLIXA [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products Inc; 2016. 3. Data on file. Mallinckrodt Hospital Products, Inc. 4. Gupta N, Chetter I, Hayes P, et al. Randomized trial of a dry-powder, fibrin sealant in vascular procedures. J Vasc Surg. 2015;62(5):1288-1295.