FDA Extends Shelf Life of Octapharma’s cutaquig® 16.5% for Adult PI Patients
As concerns about the supply of immunoglobulin rise, FDA extends expiration date for certain existing lots already in distribution and all new lots of Octapharma’s SCIg
PARAMUS, N.J. (January 05, 2021) – Octapharma USA today announced the U.S. Food & Drug Administration (FDA) has extended the expiration date of 42 existing lots of cutaquig® [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] that are currently in the distribution chain. The FDA decision extends the shelf life of all future lots of cutaquig® from 24 to 36 months when stored at 2°C to 8°C (36°F to 46°F). The six-month shelf life of cutaquig® stored at room temperature up to +25 ºC (77ºF) remains unchanged.
“The FDA extension is great news for adult primary immune disease patients concerned about the available supply of immunoglobulin products,” said Octapharma USA President Flemming Nielsen. “As the supply of immunoglobulin products faces challenges in the near future, the longer shelf life of cutaquig® is an important consideration. Octapharma has increased its production of immunoglobulin products by more than 45 percent over the last year so we have strong supply to meet patient needs.”
The FDA has approved an extension of the expiration date for cutaquig® from 24 to 36 months when stored at +2°C to +8°C (36°F to 46°F). The selected cutaquig® lots, which are listed at fda.gov, were all manufactured and distributed in 2019 and 2020. The six-month shelf life for cutaquig® stored at room temperature up to +25°C (77°F) is unchanged. Future lots of Octapharma’s subcutaneous immunoglobulin (SCIg) will be labeled according to the new dating period.
About cutaquig®
Cutaquig® (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults.
WARNING: THROMBOSIS
Thrombosis may occur with immune globulin products, including cutaquig®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
For patients at risk of thrombosis, administer cutaquig® at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Please see full prescribing information for complete boxed warning and other important information at cutaquigus.com.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Paramus, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit octapharmausa.com.