Liposorber® LA-15 System The Liposorber® LA-15 System is a blood processing system used outside of the body. This device removes certain lipoproteins from the blood. It’s used in pediatric and adult patients diagnosed with Focal Segmental Glomerulosclerosis (FSGS) either before transplant or post-transplant with FSGS recurrence. Why is the Liposorber® LA-15 System needed for FSGS patients? The Liposorber® LA-15 System is FDA-approved for use in the treatment of adult and pediatric patients with Nephrotic Syndrome associated with primary FSGS when standard treatment options are unsuccessful or post-transplant with FSGS recurrence. The adsorption columns have been shown to effectively remove lipids from the plasma in adults with familial hypercholesterolemia. The device system may also provide a similar benefit to many pediatric patients with FSGS who also have hyperlipidemia. The Liposorber® LA-15 Adsorption Columns may also remove other factors in the blood, including substances that help FSGS progress. How should I use the Liposorber® LA-15 system? The device is composed of the following: Blood withdrawal line Regeneration line Plasma line Blood return line A set of five connection lines Membrane filter Treatment with this system is conducted at a medical clinic, and each treatment takes approximately 2-3 hours. The system is used up to 12 times in nine weeks of treatment (twice weekly for three weeks, then once weekly for six weeks). What are the possible side effects of the Liposorber® LA-15 System? You may experience some of these side effects while on this treatment. Check with your doctor if you continue to have any of these side effects and they do not go away: Cardiac (including myocardial infarction) Thrombocytopenia Infection Hypersensitivity reaction Nausea Vomiting Decrease in Vitamin E level Transient decrease in serum protein and albumin level Hypotension Abdominal symptoms Flushing/blotching Angina/chest pain Fainting/lightheadedness Anemia Prolonged bleeding (at cannulation site) Hemolysis Device malfunction Vertigo Diaphoresis Uticaria Shivering Headaches What are precautionary measures I should take while using the Liposorber® LA-15 System? The device must not be used in: Patients who have been treated with ACE-inhibitors within the past 24 hours Patients for whom adequate anticoagulation cannot be achieved, such as severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or who are receiving vitamin K antagonist medications after surgery Patients for whom extracorporeal circulation therapy with Liposorber® LA-15 cannot be tolerated such as those with severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, or sever uncontrollable hypertension or hypotension Patients with hypersensitivity to dextran, heparin or ethylene oxide *Note: The decision to prescribe a medication is the responsibility of your physician/primary care provider based on his/her evaluation of your condition. The above is meant for informational purposes only. Discuss this information and all information about drugs/medications with your physician before starting or stopping any medication.