NovoThirteen

Symptomatic individuals have <1% of normal FXIII^3,4, resulting in unstable clot formations with reduced resistance to fibrinolysis¹

The initial clot forms and bleeding stops, but bleeding can resume 24-48 hours later⁴

Wound healing problems have been described in 14% of patients¹

It affects all races and genders equally1, approximately one person in 1-2 million are affected worldwide^5,6

NovoThirteen^® is indicated for the long-term prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency.

It is also approved for the treatment of breakthrough bleeding episodes during regular prophylaxis. It can be used for all age groups.¹⁰

Low ABR in children (≥6 years) and adults, and specifically 0 bleeds in pediatric patients from mentor^™ 5 trials^*7,10-13 (Mean ABR = 0.043)

Once-monthly, low volume dosing10 designed to decrease the burden of treatment

Well tolerated in pediatric patients (<6 years), children (≥6 years) and adults in the mentor^™ trials^2,7,10-13

• Drug supply is not dependent on human plasma availability and quality¹⁷

• No risk of transmission of infectious agents or allergic reactions that are typically associated with the use of plasma-derived components^7,11,17,18

• Patients do not need to be vaccinated against hepatitis A or B as a precaution, unlike with Fibrogammin^®18

• Neutralising antibodies (inhibitors)^{*†2,7,10-12}

• Thromboembolic adverse events or other safety issues reported^2,7,10-12

• Significant changes in haematology or biochemistry parameters^2,7,10-12

• Differences in treatment response or safety profile between the paediatric and the adult populations¹⁰

*Patients known to have neutralising antibodies to FXIII should not be treated with NovoThirteen^® without close monitoring.¹⁰

†Despite no neutralising antibodies in clinical trials, in potential cases with a lack of therapeutic response, patient should be screened for antibodies.