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Raplixa Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Generic Availability
NO
Raplixa Indications
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
Adult
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.
Children
Not established.
Raplixa Contraindications
Contraindications
Intravascular use. Severe or brisk arterial bleeding. Systemic reactions to human blood products.
Raplixa Boxed Warnings
Not Applicable
Raplixa Warnings/Precautions
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
