The False Interpretation of Maltose as Glucose by Some Types of Glucose Testing Systems Octapharma’s Response to Ensure

1. The False Interpretation of Maltose as Glucose by Some Types of Glucose Testing SystemsOctapharma’s Response to Ensure Patient Safety

2. A known characteristic of certain point-of-care glucose test systems • Glucose test systems using the glucose dehydrogenase-pyrroloquinolinequinone (GDH-PQQ) or the glucose-dyeoxidoreductase method of glucose determination, arenon-specific for glucose • Maltose, maltotriose and, to a lesser extent, maltotetraose are misinterpreted bythese test systems as glucose resulting in falsely elevated glucose readings • Falsely elevated glucose readings can result in the inappropriate administration of insulin and cause life-threatening hypoglycemia. Conversely, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by the false elevation of blood glucose readings • Maltose (and polymers) have been used as exipients in several parenteral drugs for decades, and have been generally considered safe • peritoneal dialysis fluid • IGIV solutions • oncology drugs

3. A known characteristic of certain point-of-care glucose test systems • Warning statements regarding non-glucose specificity are normally present in the related prescribing information/package inserts of the non-glucose specific glucometers/test strips • Warning statements regarding the potential for falsely elevated glucose reading with certain glucometers are normally present in the prescribing information/package inserts of maltose/icodextrincontaining drugs

4. Octapharma’s response • The package insert/SPC for Octagam® has contained a related drug interaction statement since the introduction of the product in the market place • In collaboration with and under the guidance of the FDA • Octapharma has sent a “Dear Dr Warning Letter” to the agreed upon parties • Octapharma has revised the warning and precaution statements in the PI

5. Octapharma’s response WARNINGS Blood Glucose Testing Some types of blood glucose testing systems (for example, those based on the glucose dehydrogenase-pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods) falsely interpret the maltose contained in Octagam® as glucose. This has resulted in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Also, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings. Accordingly, when administering Octagam® or other parenteral maltose- containing products, the measurement of blood glucose must be done with a glucose-specific method. The product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose- containing parenteral products. PRECAUTIONS Drug/Laboratory Test Interactions Octagam® contains maltose which can be misinterpreted as glucose by certain types of blood glucose testing systems (for example, by systems based on GDH-PQQ or glucose-dyeoxidoreductase methods). Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific, should be used to test or monitor blood glucose levels in patients receiving maltose-containing parenteral products, including Octagam®. The product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed to determine if the system is appropriate for use with maltosecontaining parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine ifthe system is appropriate for use with maltose-containing parenteral products (see WARNINGS).