fibrin sealant (Rx)

Brand and Other Names:Evicel, Tisseel VH, more...Artiss, TachoSil
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Dosing & Uses

AdultPediatric

Dosage Forms & 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)
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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

Dosage Forms & 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)
more...

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
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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

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Pregnancy & 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.

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Pharmacology

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)

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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