Dosing and uses of Raplixa (fibrinogen/thrombin)
Adult dosage forms and strengths
fibrinogen/thrombin
topical dry powder
- (79mg/699 IU)/g
- Supplied in single-use glass vials: 0.5g, 1g, and 2g
Hemorrhage Control
Topical 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 (eg, suture, ligature, cautery) is ineffective or impracticaL
Required amount to stop bleeding varies and is based on the size of the bleeding area
Not to exceed total dose of 3 g per surgery
Also see Administration section for complete details
Direct application dose
- Dose according to maximum surface area of bleeding area to be treated
- 25 cm²: 0.5 g vial
- 50 cm²: 1 g vial
- 100 cm²: 2 g vial
Dose using RaplixaSpray device
- Dose according to maximum surface area of bleeding area to be treated
- 50 cm²: 0.5 g vial
- 100 cm²: 1 g vial
- 200 cm²: 2 g vial
Pediatric dosage forms and strengths
Safety and efficacy not established
Raplixa (fibrinogen/thrombin) adverse (side) effects
Adverse effects reported were similar to use of gelatin sponge alone
>10%
Procedural pain (52%)
Nausea (26%)
Constipation (16%)
Incision site pain (12%)
1-10%
Pyrexia (8%)
Anemia (7%)
Vomiting (7%)
Hypotension (7%)
Pruritus (6%)
Hypertension (5%)
Antithrombin antibodies (2%)
Warnings
Contraindications
Intravascular application
Severe or brisk arterial bleeding
Known anaphylactic or severe systemic reactions to human blood products
Cautions
Life-threatening thromboembolic events may result from intravascular application (see Contraindications)
Air or gas embolism has occurred with the use of spray devices using pressure regulators to administer fibrin sealants; this appears to be related to the use of the spray device at higher than manufacturer recommended pressures and in close proximity to the tissue surface; minimize this risk by precisely following manufacturer’s instructions for RaplixaSpray device (see Administration and product prescribing information)
Made from human plasma; risk of transmitting infectious agents (eg, CJD); manufacturing steps designed to reduce this risk are used, as is screening of plasma donors
Hypersensitivity reactions may occur, including hives, generalized urticaria, tightness of chest, wheezing, hypotension, and anaphylaxis; if these symptoms occur, discontinue immediately
Pregnancy and lactation
Pregnancy
Animal reproduction studies have not been conducted
It is also not known whether fibrinogen/thrombin can cause fetal harm when administered to pregnant women or can affect reproductive capacity
Should be given to a pregnant woman only if clearly needed
Lactation
Unknown if distributed in human breast milk; because many drugs are excreted in human milk, caution should be exercised when administering to breastfeeding women
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Raplixa (fibrinogen/thrombin)
Mechanism of action
Mixture of human plasma-derived fibrinogen and human plasma-derived thrombin powders that are designed to mimic the final steps in the coagulation cascade
Powder dissolves readily on contact with aqueous fluids (eg, blood), activating thrombin, which triggers an immediate conversion of fibrinogen into fibrin and subsequent clot formation
Pharmacokinetics
Because fibrinogen/thrombin is applied only topically, systemic exposure or distribution to other organs or tissues is not expected
Administration
General Application
Apply to the surface of bleeding tissue only; administer directly from the vial or using the RaplixaSpray device
For topical use only
Do not reconstitute
Use within 1 hr of opening viaL
May be used at multiple bleeding sites in the same patient
Use no more than 2 vials with the RaplixaSpray device
To administer a third vial, open a new device
Application with Gelatin Sponge
1. Open the pouch and take out the vial following standard sterile technique to ensure 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 to an appropriate size for the bleeding site
4. Remove stopper and sprinkle a uniform thin coating of powder gently onto bleeding site and apply gentle pressure with gelatin sponge using sterile gauze, Or
Remove stopper and sprinkle a thin layer of powder gently onto a prewetted gelatin sponge and place onto the bleeding site with gentle pressure using sterile gauze
Application Using RaplixaSpray Device
1. Prepare the pressure regulator (air or CO2) according to the manufacturer’s instructions for use
2. Open the pouch and take out the vial following standard sterile technique to ensure the vial and surgical field remain sterile
3. Check that the powder is in the bottom of the vial; remove the flip-off top, leaving the stopper in place until use
4. Prepare gelatin sponge by trimming to an appropriate size for the bleeding site
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
6. Activate air or gas flow
7. Device is now ready for use; DO NOT push button until ready for use
8. Check that the pressure is 1.5 bar (22 psi)
9. Ensure the vial is kept within 45° of vertical at all times
10. Hold nozzle at a minimum distance of 5 cm (or 2 inches) from the bleeding site
11. Start application by gently pressing the operating button
12. Powder should cover the bleeding surface as a uniform thin coating; apply powder within 10-60 seconds
13. Immediately after powder application, place a gelatin sponge, trimmed to the approximate size, on top of the 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; hold the gelatin sponge in place with manual pressure using sterile gauze
14. 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 with the RaplixaSpray device
15. To administer a third vial, open a new RaplixaSpray delivery device (repeat steps 1-13)
Storage
Store unopened vials at 2-25°C (36-77°F); refrigeration is not required
Do not freeze
Do not use beyond the expiration date printed on the carton or viaL
Use powder within 1 hr after opening a viaL
