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Indications and clinical use:

NiaStase RT^® (eptacog alfa, activated) is indicated:

In hemophilia A/B patients with inhibitors to FVIII or FIX, respectively, for the treatment of bleeding episodes (including treatment and prevention of those occurring during and after surgery)

Based on the data obtained so far with rFVIIa in the treatment of hemophilia patients with inhibitors, the apparent lack of anamnestic response during and after exposure to rFVIIa makes it suitable for use in all inhibitor patients.

• For the treatment of severe bleeding episodes in Glanzmann’s thrombasthenia with clinical refractoriness and/or platelet-specific antibodies, or where platelets are not immediately available
• For the prevention of bleeding in surgical interventions or invasive procedures in Glanzmann’s thrombasthenia with clinical refractoriness and/or platelet specific antibodies, or where platelets are not readily available
• In adult patients with acquired hemophilia, for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures
• In patients with congenital Factor VII deficiency, for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures

Contraindications:

• Known hypersensitivity to the active substance, the excipients, or to mouse, hamster or bovine protein

Most serious warnings and precautions:

Arterial and venous thromboembolic adverse events: These adverse events have been reported after treatment with rFVIIa, mostly in patients with predisposing concurrent risk factors.

Thromboembolic events in off-label use: Reports of fatal and non-fatal outcomes, including those associated with thromboembolic events, have been received.

Antibody development: Patients with inherent FVII deficiency may have pre-existing or may develop anti-FVII antibodies during therapy with NiaStase RT^®. The clinical significance of these antibodies is unknown.

Other relevant warnings and precautions:

• The extent of risk of thrombotic adverse events after treatment with rFVIIa in hemophilia patients with inhibitors is not known, but is considered to be low
• Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia or concomitant treatment with aPCCs/PCCs (activated or non-activated prothrombin complex concentrates) may have an increased risk of developing thrombotic events due to their underlying condition or concomitant treatment
• Closely monitor for signs and symptoms of unfavourable activation of the coagulation system or thrombosis
• Hypersensitivity and anaphylaxis reactions have rarely been reported with the use of rFVIIa
• As a precautionary measure, it is preferable to avoid the use of NiaStase RT^® during pregnancy
• Decide whether to continue/discontinue breastfeeding or NiaStase RT^® taking into account the benefit of breastfeeding to the child and NiaStase RT^® to the woman
• Data are insufficient to support the recommendation of higher doses in children
• Clinical studies of NiaStase RT^® in hemophilia and Glanzmann’s thrombasthenia did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects
• Safety and efficacy in patients <17 years with AH have not been established

For more information:

Please visit http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/niastase-product-monograph.pdf for more information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-465-4334.