Artiss

Generic Name: fibrin sealant (human)
Date of Approval: March 19, 2008
Company: Baxter Healthcare Corporation

Treatment for: Adhering Skin Grafts in Burn Patients

FDA Approves Artiss

The U.S. Food and Drug Administration (FDA) has approved Artiss (Fibrin Sealant (Human)), a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients.

Artiss allows for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds, relative to rapid-setting fibrin sealants, which set in five to 10 seconds. Skin grafts can be fixed without the use of staples or sutures, which may help reduce post-operative complications and patient anxiety about pain during staple removal.

The FDA approval is based on Phase III study results, which were also published in the March/April 2008 issue of The Journal of Burn Care and Research. The multi-center, prospective, randomized, controlled and blinded study compared the use of Artiss to staples in 138 burn patients requiring skin grafting. Artiss is safe and effective for attaching skin grafts with outcomes as good as staple fixation.

Frequent adverse events, seen in both treatment groups, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures.

Artiss is a biologically active sealant consisting of human fibrinogen and low concentration human thrombin. It will be available in two forms: a pre- filled syringe (frozen) formulation and a lyophilized form. Both dosage forms, once prepared and ready to use, can be sprayed, thus enabling application in a thin and even layer.

Important Safety Information

Artiss is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations.

Artiss is not indicated for hemostasis.

Do not inject Artiss directly into blood vessels. Intravascular application may result in life-threatening thromboembolic events.

Do not use Artiss in individuals with a known hypersensitivity to aprotinin.

Artiss is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Apply Artiss as a thin layer. Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.

Adverse reactions occurring in greater than 1% of patients treated with Artiss were skin graft failure and pruritus.

Please see Artiss Prescribing Information for full prescribing details.

Source: Baxter Healthcare Corporation

Highlights of Artiss Prescribing Information

These highlights do not include all the information needed to use Artiss safely and effectively. See full prescribing information for Artiss.

For Topical Use Only

Frozen solution and lyophilized powder for solution for topical application

Artiss Indications and Usage

Artiss is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations

Artiss is not indicated for hemostasis

Dosage and Administration

For Topical Use Only. Do Not Inject. Apply on surface of prepared wound beds only

Artiss Kit (Freeze-Dried) requires reconstitution prior to use

Artiss Pre-filled Syringe (Frozen) requires thawing prior to use

Apply as a thin layer using the Easyspray and Spray Set

Dosage: 2 mL will cover approximately 100 cm² surface area

Store Artiss Kit (Freeze-Dried) at 2-25°C. Avoid Freezing. Use within 4 hours of reconstitution

Store Artiss Pre-filled Syringe (Frozen) at ≤ -20°C. Unopened pouches, thawed at room temperature, may be stored for up to 7 days at 15-25°C. The product must be used within 12 hours after warming to 33-37°C or removal from original pouches. Do not refrigerate or refreeze

Vials and pre-filled syringes are for single use only. Discard unused contents

Dosage Forms and Strengths

Artiss Kit (Freeze-Dried) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with and without the DUPLOJECT system

Artiss Pre-filled Syringe (Frozen) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with the DUO set

Contraindications

• Do not inject directly into the circulatory system
• Do not use in individuals with a known hypersensitivity to aprotinin

Artiss Warnings and Precautions

• This product is made from pooled human plasma which may, theoretically, contain infectious agents
• Apply only as thin layer
• Use caution when applying with pressurized gas
• Exposure to solutions containing alcohol, iodine or heavy metals may cause Artiss to be denatured

Adverse Reactions

Adverse reactions occurring in greater than 1% of patients treated with Artiss were skin graft failure and pruritus

To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Patient Counseling Information

Because this product is made from human plasma, the physician should discuss the risks and benefits with the patient.

Patients should be instructed to consult their physician if symptoms of B19 virus infection appear (fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain.

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