• Bleeding disorders

Raplixa Generic Name & Formulations

General Description

Human fibrinogen 79mg, human thrombin 699 IU; per 1g; ready-to-use pwd; preservative-free; contains trehalose, calcium chloride.

Pharmacological Class

Topical hemostatic.

How Supplied

Single-use vial (0.5g, 1g, 2g)—1


Generic Availability


Raplixa Indications


Adjunct to hemostasis for mild-to-moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical. Use in conjunction with absorbable gelatin sponge or RaplixaSpray device.

Raplixa Dosage and Administration


See full labeling. Apply to surface of bleeding tissue only; give directly from vial using absorbable gelatin sponge or RaplixaSpray device (max 2 vials per device). Individualize dose based on size of bleeding area; max total dose 3g per surgery. Max surface area (25cm2 [vial] or 50cm2 [RaplixaSpray]): use 0.5g; (50cm2 [vial] or 100cm2 [RaplixaSpray]): use 1g; (100cm2 [vial] or 200cm2 [RaplixaSpray]): use 2g.


Not established.

Raplixa Contraindications


Intravascular use. Severe or brisk arterial bleeding. Systemic reactions to human blood products.

Raplixa Boxed Warnings

Not Applicable

Raplixa Warnings/Precautions


For topical use only. Life-threatening thrombosis possible from intravascular application. Monitor BP, pulse, oxygen saturation, end tidal CO2 for signs/symptoms of embolism. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Discontinue immediately if hypersensitivity reactions occur. Pregnancy. Nursing mothers.

Raplixa Pharmacokinetics

See Literature

Raplixa Interactions

Not Applicable

Raplixa Adverse Reactions

Adverse Reactions

Procedural pain, nausea, constipation, pyrexia, hypotension; infection, possible antibody formation.

Raplixa Clinical Trials

See Literature

Raplixa Note

Not Applicable

Raplixa Patient Counseling

See Literature