ARTISS

What it is

ARTISS is a two-component fibrin sealant made from pooled human plasma. Each pack contains two separate preloaded chambers in one double-chamber syringe: chamber one contains Sealer Protein Solution (with aprotinin), deep frozen (1 mL, 2 mL or 5 mL), and chamber two contains Thrombin Solution (with calcium chloride), deep frozen (1 mL, 2 mL or 5 mL), resulting in 2 mL, 4 mL or 10 mL total volume of product ready for use.

Approved indications

— Adherence of autologous skin grafts in burn patients. — Adherence of tissue flaps during facial rhytidectomy surgery (face-lift).

Dosing overview

ARTISS should be applied thinly (2 mL/100 cm²) to avoid formation of excessive granulation tissue and interference with wound healing. The required dose depends on the size of the surface to be covered. The approximate surface areas covered by each package size of ARTISS by spray application are: 100 cm² requires 2 mL, 200 cm² requires 4 mL, and 500 cm² requires 10 mL. This recommended dose applies to all age groups.

Key safety warnings

Air embolism has occurred with the use of a spray device to administer fibrin sealant. This appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. Life-threatening or fatal air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants, and these events appear to be related to the use of the spray device at higher than recommended pressure and/or in close proximity to the tissue surface. Administration of ARTISS may result in allergic reactions in some patients. Manifestations of hypersensitivity reactions to ARTISS observed include: bradycardia, tachycardia, hypotension, flushing, bronchospasm, wheezing, dyspnoea, nausea, urticaria, angioedema, pruritus, erythema, and paraesthesia. Fatal anaphylactic reactions, including anaphylactic shock, have also been reported with ARTISS. Sealer Protein Solution and Thrombin Solution are made from human plasma. Products made from human plasma may contain infectious agents which can cause disease, such as viruses and theoretically, the agent that causes Creutzfeldt-Jakob Disease (CJD) in humans. Despite measures to prevent infections, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.

Contraindications

Known hypersensitivity to aprotinin or known hypersensitivity to any other component of ARTISS is contraindicated. Injection of ARTISS into tissues is contraindicated. Such use has been associated with inadvertent intravascular injection, that may result in life-threatening thromboembolic complications.

Regulatory history

ARTISS was first listed on the ARTG on 19 August 2010. An AusPAR was approved on 21 December 2011 for the extension of indications for ARTISS to include adherence of skin flaps and grafts during facial plastic and reconstructive surgery, based on positive efficacy and safety findings from clinical studies.