Artiss

What is Artiss?

• Artiss (Fibrin Sealant (Human)) is a two-component (Sealer Protein (Human) and Thrombin (Human)) fibrin sealant made from pooled human plasma.

What are the uses of this medicine?

Artiss (Fibrin Sealant (Human)) is a fibrin sealant used to:

• 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.
• Adhere tissue flaps during facial rhytidectomy surgery (face-lift).

Limitations of use:

• Artiss is not indicated as an adjunct to hemostasis.

How does this medicine work?

• Upon mixing Sealer Protein (Human) and Thrombin (Human), the two components mimic the final stage of the blood coagulation cascade.
• Soluble fibrinogen is transformed into fibrin that adheres to the wound surface and to the skin flap or graft to be affixed.
• Due to the low thrombin concentration, initial polymerization will take up to 60 seconds.
• The fibrin clot continues to strengthen for up to 2 hours after application.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a known hypersensitivity to aprotinin.

• Do not spray where the minimum recommended distance from the applicator tip to the target site cannot be assured.
• Do not inject directly into the circulatory system.

What drug interactions can this medicine cause?

• Oxycellulose containing preparations may reduce the efficacy of Artiss and should not be used as carrier materials.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage:

• Individualize the amount based on the size of the surface to be covered.
• 2 mL will cover approximately 100 cm2 surface area
• 4 mL will cover approximately 200 cm2 surface area
• 10 mL will cover approximately 500 cm2 surface area

Administration:

• For topical use only.
• Apply a thin layer using the Easyspray and Spray Set or an equivalent device cleared by FDA for application of Artiss.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 2 mL, 4 mL, and 10 mL (total volume) pre-filled syringe.

This medicine is available in fallowing brand namesː

• Artiss

What side effects can this medication cause?

The most common side effects of this medicine include: In patients with burns:

• Skin graft failure
• hematoma
• pruritus

In patients with facial rhytidectomy:

• Hematoma/seroma

What special precautions should I follow?

• Hypersensitivity reactions, including anaphylaxis, can occur. Should symptoms occur, discontinue and administer appropriate treatment.
• Any application of pressurized air or gas is associated with a potential risk of air or gas embolism, tissue rupture, or gas entrapment with compression, which may be life threatening or fatal. 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 CO2, Medical Air or Nitrogen CO2.
• The sealer protein and thrombin solutions can be denatured by alcohol, iodine or heavy metal ions (e.g., antiseptic solutions). If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before application of Artiss and made as dry as possible.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Artiss use in pregnant women to inform a drug-associated risk of adverse developmental outcomes.
• Artiss should be given to a pregnant woman only if deemed medically necessary.

Can this medicine be used in children?

• The efficacy and safety was established in utilizing Artiss to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in pediatric populations greater than or equal to 1 year of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• FIBRINOGEN HUMAN
• HUMAN THROMBIN

Inactive ingredients:

• APROTININ
• ALBUMIN HUMAN
• TRISODIUM CITRATE DIHYDRATE
• HISTIDINE
• NIACINAMIDE
• POLYSORBATE 80
• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured for:

• Baxter Healthcare Corporation
• One Baxter Parkway
• Deerfield, IL USA

• Made in Belgium

What should I know about storage and disposal of this medication?

• Store in original carton to protect from light. Do not use after the expiration date. Discard if packaging of any component is damaged.
• Long term: Store at ≤ -20°C.
• Short term: Room Temperature Thawing: Unopened pouches, thawed at room temperature, may be stored for up to 14 days at room temperature (15°C to 25°C) after removal from the freezer.
• Quick Thawing: Maintain the product at 33°C to 37oC until use. If the product is removed from original pouch or warmed to 33°C to 37oC it must be used within 12 hours.
• Do not refrigerate or re-freeze after thawing.
• Do not microwave.

• Dailymed label info on Artiss
• FDA Artiss

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