Thrombin Alfa (Recombinant) (Topical)

Class: Hemostatics
VA Class: BL116
Chemical Name: Human thrombin (recombinant, glycosylated)
Molecular Formula: C₁₅₁₁H₂₃₄₂N₄₁₈O₄₃₆S₁₅
CAS Number: 869858-13-9
Brands: Recothrom

Medically reviewed by Drugs.com on Mar 21, 2022. Written by ASHP.

Introduction

Hemostatic agent; biosynthetic (recombinant DNA origin) preparation of naturally occurring human thrombin.

Uses for Thrombin Alfa (Recombinant) (Topical)

Hemorrhage

Used topically as an aid in achieving hemostasis at accessible sites of oozing blood and minor bleeding from capillaries and small venules when control of bleeding using standard surgical measures (e.g., suture, ligature, electrocautery) is ineffective or impractical.

May be used alone or in conjunction with an absorbable gelatin sponge during various types of surgery (e.g., spinal surgery, liver resection, peripheral arterial bypass surgery).

Do not use for massive or brisk arterial bleeding. (See Contraindications.)

Thrombin Alfa (Recombinant) (Topical) Dosage and Administration

Administration

Topical Administration

Apply topically as a solution; do not inject. (See Contraindications.) Separate topical thrombin solutions from parenteral preparations to avoid inadvertent injection. (See Thrombosis under Cautions.) Do not leave reconstituted solutions in syringes as an intermediate step.

Apply directly to surfaces of bleeding tissue using a sterile syringe sprayer or spray pump; alternatively, may apply with an absorbable gelatin sponge. Consult manufacturer's instructions for proper assembly and use of the syringe sprayer or spray pump (available as part of the spray applicator kit).

When used in conjunction with an absorbable gelatin sponge, transfer solution to a sterile bowl or basin. Immerse sponge strips of the desired size in solution to allow complete saturation. Gently squeeze sponge strips to remove excess drug and apply to bleeding site in a single layer. Consult manufacturer's information for detailed instructions on use of absorbable gelatin sponge preparations.

Reconstitution

Using a needle-free transfer device, add 5 or 20 mL of the supplied diluent (0.9% sodium chloride injection) to a vial containing 5000 or 20,000 units, respectively, of lyophilized thrombin alfa (thrombin [recombinant]) to provide a solution containing 1000 units/mL. Gently swirl vial until powder is completely dissolved.

Draw reconstituted solution into a sterile syringe and apply auxiliary label indicating that the solution is for topical use only.

Use within 24 hours of reconstitution.

Dosage

Adults

Hemorrhage

Topical

Volume of drug required to achieve hemostasis depends on total number of bleeding sites, surface area being treated, and method of application.

Hemostasis usually achieved within 10 minutes following a single application.