These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS.
ARTISS [Fibrin Sealant (Human)]
Solution for topical application
Initial U.S. Approval: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2) 06/2022
Warnings and Precautions (5.3) 06/2022
INDICATIONS AND USAGE
ARTISS is a fibrin sealant indicated to:
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Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age (1)
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Adhere tissue flaps during facial rhytidectomy surgery (face-lift) (1)
ARTISS is not indicated as an adjunct to hemostasis (1)
DOSAGE AND ADMINISTRATION
For topical use only. (2)
Individualize the amount based on the size of the surface to be covered. (2)
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2 mL will cover approximately 100 cm2 surface area
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4 mL will cover approximately 200 cm2 surface area
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10 mL will cover approximately 500 cm2 surface area
Apply a thin layer using the Cannula or EASYSPRAY and Spray Set or an equivalent device cleared by FDA for application of ARTISS. (2.2)
DOSAGE FORMS AND STRENGTHS
ARTISS solution is available as a 2 mL, 4 mL, and 10 mL (total volume) pre-filled syringe with the DUO Set A (AST Syringe) or DUPLOJECT COMBI (PRIMA Syringe). (3)
CONTRAINDICATIONS
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Do not inject directly into the circulatory system (4)
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Do not use in individuals with a known hypersensitivity to aprotinin (4)
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Do not spray where the minimum recommended distance from the applicator tip to the target site cannot be assured (4).
WARNINGS AND PRECAUTIONS
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Hypersensitivity reactions, including anaphylaxis, can occur. Should symptoms occur, discontinue and administer appropriate treatment. (5.1)
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To reduce the risk of potential life-threatening gas embolism, spray using only the appropriate pressurized gas at the recommended pressure (21.8-29.0 psi) and distance (10-15 cm). Use the EASYSPRAY device connected to a Medical grade CO2, Compressed Air or Nitrogen (5.2)
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ARTISS may denature when exposed to solutions containing alcohol, iodine or heavy metals. (5.3)
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As ARTISS is made from human plasma, it may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the classic Creutzfeldt-Jakob disease agent (5.4)
ADVERSE REACTIONS
Adverse reactions reported during clinical trials in greater than 1% of subjects were:
Burns: Skin graft failure, hematoma and pruritus (6.1)
Facial Rhytidectomy: Hematoma/seroma (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-888-229-0001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2022
