On April 29, the FDA approved the biologics license for a new product, Ixinity, a recombinant coagulation factor IX drug, by Cangene Corporation. A spokesperson for the parent company Emergent BioSolutions, Inc. said the product should be available within 60 days. As such, it should be released by the end of the month.
What is Ixinity?
The product labeling indicates it is intended for the use of preventing and controlling bleeding episodes in patients who suffer from hemophilia B, who are at least age 12. This product can also be used in perioperative management of these patients.
The product contains tenonacog alfa, a purified glycoprotein made from the ovary cells of Chinese hamsters. The amino acid sequence can be compared to an allelic form of plasma-derived factor IX.
Since the product contains trace amounts of the hamster protein, it should not be given to any patient that is allergic or hypersensitive to the protein. No protein, either human or animal, is added during the manufacturing process.
Most Common Side Effects
A small clinical study with 77 participants showed the most common adverse reaction to the medication was headache. This only occurred in two patients.
Dosage and Treatment Duration
The exact amount taken and how long it will be taken will depend on a number of factors, one of which is the severity of the IX factor deficiency. The label provides the necessary information to calculate doses and recommendations for peak factor IX concentration. The label also provides information about how to space the doses and how long therapy should last.
Each kit will have one or two vials of lyophilized powder, providing either 500, 1,000, or 1,500 IU of the factor IX, which the amount stated on the label. The kit also contains a 10-cc syringe prefilled with 5 mL of sterile water for injection, a vial adapter with a filter, and a 20 mL syringe to administer the biological agent.
Pharmacies should store the vials of powder at anywhere between 2 and 25℃ or 35.6 and 77℉. Vials should never be frozen.
After the sterile water has been added to the powder, it should be administered to the patient within three hours, and never refrigerated during that time. The labeling includes instructions for pharmacists on how to prepare and administer the medication, as well as information for patients.