New biologic to control bleeding for hemophilia B patients

May 5, 2015

At the end of April, FDA approved a new biologic to help prevent and control bleeding in patients with hemophilia B who are 12 years and older. It also is approved for use in perioperative management in this patient population.

At the end of April, FDA approved a new biologic to help prevent and control bleeding in patients with hemophilia B who are 12 years and older. It also is approved for use in perioperative management in this patient population.

The recombinant coagulation factor IX (Ixinity, Cangene Corporation) is a glycoprotein that has been genetically engineered from Chinese hamster ovary cells. The sterilized product is formulated as a lyophilized powder and must be reconstituted with sterile water for intravenous administration, according to the manufacturer’s label.

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Ixinity should not be used in patients with a hypersensitivity to hamster protein or any of its excipients (histidine, mannitol, trehalose dehydrate, sodium chloride, polysorbate 80).

Multicenter study results

The biologic was evaluated in an open-label, uncontrolled multicenter study, including 77 patients, with 76 having severe or moderately severe hemophilia B or clinically severe hemophilia B. Sixty-eight of the study participants had been previously treated with another factor IX preparation at least 150 times.

More than 500 bleeding episodes were treated with the biologic Ixinity, with 360 bleeding episodes (70.9%) resolving after one single infusion. Sixty-six bleeding episodes (13.0%) required two infusions, and 24 bleeding episodes (4.7%) needed five or more infusions.

During perioperative management, 16 men required major surgery and received a bolus or continuous infusion of Ixinity. No transfusions were needed during the 19 major procedures in this group of 16 men.

Adverse reactions during clinical trials included two cases of headache, and one case each of the following: hemophilia, asthenia, injection site discomfort, influenza, dysgeusia, lethargy, apathy, depression, and pruritic rash.

Dose and length of treatment depend on the severity of factor IX deficiency. Consult the label for guidance, which includes how to prepare and administer the biologic.