Sanofi-Aventis Korea said Wednesday that Korea’s Ministry of Food and Drug Safety has approved updated storage conditions for Alprolix, allowing the hemophilia B treatment to be stored at room temperature for up to six months.
Previously, Alprolix was required to be refrigerated at 2°C to 8°C. Under the revised prescribing information, the therapy may now be stored below 30°C for a single period of up to six months within its overall shelf life.
Patients are instructed to record the date the product is removed from refrigeration and use it within six months. Once stored at room temperature, the therapy should not be returned to refrigerated storage, and unused product exceeding the storage period must be discarded.
Sanofi Korea said the labeling change is expected to improve convenience for patients who need to carry treatment during travel, outdoor activities or business trips, where maintaining refrigerated conditions can be difficult.
Bae Kyung-eun, country lead and pharma general manager for Korea, Australia and New Zealand at Sanofi, said the update could help patients manage treatment more consistently in daily life.
Hemophilia B is a lifelong bleeding disorder caused by factor IX deficiency and requires ongoing preventive treatment to reduce bleeding episodes.
Alprolix is an extended half-life factor IX therapy that uses Fc fusion protein technology to prolong the circulation time of clotting factor IX. According to the company, the therapy extends factor IX half-life by about 2.4 times compared with standard half-life products.
The therapy received Korean approval in 2017 for the prevention and control of bleeding episodes, perioperative management and routine prophylaxis in hemophilia B patients. It was launched in Korea in 2020.
Lee Han-soo
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