NOVOTHIRTEEN

What it is

NovoThirteen is recombinant human factor XIII (rFXIII) 2500 IU (15 mg) powder and solvent for solution for injection. NovoThirteen contains catridecacog, a recombinant coagulation factor XIII A-subunit with a molecular mass of approximately 83.2 kDa. Catridecacog is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology, without the use of animal derived materials. One vial of NovoThirteen contains 2500 IU catridecacog per 3 mL after reconstitution, corresponding to a concentration of 833 IU/mL.

Approved indications

— Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

Dosing overview

The recommended dose is 35 IU/kg body weight once monthly (every 28 days ± 2 days), administered as an intravenous bolus injection. The preparation should be administered as a slow bolus intravenous injection at a rate not higher than 2 mL/minute. Dose adjustment can be considered necessary by the physician in certain situations where the prevention of bleeding is not appropriately covered by the recommended 35 IU/kg/month dose, based on FXIII activity levels. When NovoThirteen is administered to small children weighing less than 24 kg, the reconstituted NovoThirteen should be diluted with 6.0 mL of sodium chloride 0.9% solution for injection.

Key safety warnings

NovoThirteen may cause allergic reactions including anaphylactic reaction, and patients should be informed of the early signs of hypersensitivity reactions (including hives, generalised urticaria, tightness of the chest, wheezing, hypotension) and anaphylaxis. Incorrect storage of the product after reconstitution must be avoided as it may result in loss of sterility and in increased levels of non-proteolytically activated rFXIII, which may increase the risk of thrombosis. In case of predisposition to conditions of thrombosis, caution should be exercised due to the fibrin-stabilising effect of NovoThirteen, as a stabilisation of the thrombus might occur, resulting in increased risk of vessel occlusions. Recombinant FXIII may contain trace amounts of yeast protein and therefore care should be taken when administering NovoThirteen to patients with known allergy to yeast.

Contraindications

NovoThirteen is contraindicated in patients with a known hypersensitivity to rFXIII or any of the excipients of NovoThirteen.

Regulatory history

NovoThirteen was first included in the Australian Register of Therapeutic Goods on 7 November 2013. The TGA approved NovoThirteen (catridecacog) on 4 November 2013 for routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency. The TGA found no objections from a quality and safety perspective for catridecacog.