Dosing and uses of Evicel, Tisseel VH (fibrin sealant)
Adult dosage forms and strengths
kit
- 67-106 mg/mL fibrinogen: 2.5-6.5 units/mL thrombin (Artiss)
- 67-106 mg/mL fibrinogen: 400-625 units/mL thrombin (Tisseel)
- 55-85 mg/mL fibrinogen and 800 units/mL thrombin (Evicel)
patch
- 3.6-7.4 mg/cm² fibrinogen and 1.3-2.7 units/cm² (TachoSil)
Adjunct to Hemostasis
Follow Mfr's instructions for reconstitution and application
EviceL
- Indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (eg, suture, ligature, cautery) is ineffective or impractical
- Spray or drop onto surface of bleeding tissues in short bursts (0.1-0.2 mL); if hemostatic effect not complete, apply a second layer; if maximum area to be sealed is 20 cm² use 2 mL; if area to be sealed is
- If maximum area to be sealsed is 20 cm² use 2 mL
- If maximum area to be sealed is 40 cm² use 4 mL
- If maximum area to be sealed 100 cm² use 10 mL
TachoSil Patch
- Suppportive treatment in surgery for imporvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient
- If maximum patches to be applied is 7 apply patch size 9.5 cm x 4.8 cm
- If maximum patches to be applied is 14 apply patch size 4.8 cm x 4.8 cm
- If maximum patches to be applied is 42 apply patch size 3.0 cm x 2.5 cm
Tisseel VH
- Hemostasis: indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of blunt or penetrating splenic injuries when control of bleeding by conventional surgical techniques (eg, suture, ligature, cautery) is ineffective or impractical
- May be used in fully heparinized patients undergoing cardiopulmonar y bypass
- Sealing: Indicated as an adjunct to standard surgical techniques (eg, suture, ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies
- If maximum area to be sealsed is 8 cm² via cannula or 100 cm² using spray, use 2 mL
- If maximum area to be sealed is 16 cm² via cannula or 200 cm² using spray, use 4 mL
- If maximum area to be sealed 40 cm² via cannula or 500 cm² using spray, use 10 mL
Autologous Skin Graft Adherence
Artiss
- Indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to1 year of age
- Adhering tissue flaps during facial rhytidectomy surgery (face-lift)
- Not indicated as an adjunct to hemostasis
- If graft fixation area is 100 cm² use 2 mL
- If graft fixation area is 200 cm² use 4 mL
- If graft fixation area is 500 cm² use 10 mL
Tissue Flap Adherence in Facelift
Artiss
- Spray topically in an even thin layer over the wound bed immediately prior to attaching skin flap
- If graft fixation area is 100 cm² use 2 mL
- If graft fixation area is 200 cm² use 4 mL
- If graft fixation area is 500 cm² use 10 mL
Pediatric dosage forms and strengths
kit
- 67-106 mg/mL fibrinogen: 2.5-6.5 units/mL thrombin (Artiss)
- 67-106 mg/mL fibrinogen: 400-625 units/mL thrombin (Tisseel)
- 55-85 mg/mL fibrinogen and 800 units/mL thrombin (Evicel)
Adjunct to Hemostasis
Indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (eg, suture, ligature, cautery) is ineffective or impracticaL
Follow Mfr's instructions for reconstitution and application
EviceL
- <6 months: Safety and efficacy not established
- ≥6 months: Spray or drop onto surface of bleeding tissues in short bursts (0.1-0.2 mL); if hemostatic effect not complete, apply a second layer; if maximum area to be sealed is 20 cm² use 2 mL
- If area to be sealed is
- If maximum area to be sealed is 20 cm² use 2 mL
- If maximum area to be sealed is 40 cm² use 4 mL
- If maximum area to be sealed 100 cm² use 10 mL
TisseeL
- Also indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies
- <1 month: Safety and efficacy not established
- ≥1 month
- If maximum area to be sealed is 8 cm² via cannula or 100 cm² using spray;, use 2 mL
- If maximum area to be sealed is 16 cm² via cannula or 200 cm² using spray, use 4 mL
- If maximum area to be sealed 40 cm² via cannula or 500 cm² using spray, use 10 mL
Autologous Skin Graft Adherence
Artiss
- <1 year: Safety and efficacy not established
- Indications
- Indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to1 year of age
- Adhering tissue flaps during facial rhytidectomy surgery (face-lift)
- Not indicated as an adjunct to hemostasis
- Graft fixation area
- If graft fixation area is 100 cm² use 2 mL
- If graft fixation area is 200 cm² use 4 mL
- If graft fixation area is 500 cm² use 10 mL
Warnings
Contraindications
Hypersensitivity to product or other components
Massive or brisk arterial bleeding
Intravascular use - risk of life-threatening thromboembolic events
Do not spray product where the minimum recommended distance from the applicator tip to the target site cannot be assured
Cautions
Theoretical risk of exposure to blood-borne pathogens
Exposure to iodine, alcohol, or heavy metal my denature fibrinogen and thrombin proteins; if used , rinse area before applying fibrin sealant
Air or gas embolism may occur when administered via spray device; avoid pressure >20-25 psi
Artiss is not to be used for hemostasis (not indicated)
Tisseel is not to be used with oxycellulose-containing preparations; may decrease efficacy
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; use with caution
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 Evicel, Tisseel VH (fibrin sealant)
Mechanism of action
Forms fibrin clot from fibrinogen to achieve hemostasis
Pharmacokinetics
Onset of action: 2 hr (Artiss; full adherence achieved); 4-10 min (Evicel; time to hemostasis); 6 min (TachoSil; time to hemostasis); 5 min (Tisseel; time to hemostasis)
