If you are unable to see the message below, click here to view.   Now available New Procath™ (tenecteplase)   Procath is indicated for improvement of blood flow rate (BFR) in hemodialysis (HD) catheters in adults To learn about Procath, visit www.Procath.com Procath Now FDA Approved The safety and efficacy of Procath were evaluated in 2 clinical studies • The safety and efficacy of Procath were evaluated in 2 clinical studies in patients with dysfunctional HD catheters • A placebo-controlled, double-blind, randomized, multicenter study (Study 1) and an open-label multicenter study (Study 2) investigated the use of Procath in adult patients who had a cuffed, tunneled HD catheter Efficacy results after the initial dose * Analysis of covariance adjusted for duration of dysfunction and baseline BFR. Efficacy results after the second dose Study 1 (TROPICS 3) All patients had 2 mg of Procath or placebo (study drug) instilled into each lumen of the HD catheter. After a dwell time of 1 hour, study drug was withdrawn and patients underwent HD. Treatment outcome was determined at the end of visit 1, with BFR measured 30 minutes before the end of the HD session and at the end of the session to assess catheter function and determine treatment outcome. Two treatment regimens were evaluated. In 1 regimen, 63 patients without improvement in function following the first dose of either Procath or placebo received open-label Procath instilled into each lumen at the end of HD at visit 1 for an extended dwell (up to 72 hours) until the next HD session. In the other regimen, 49 patients who had a BFR <300 mL/min at the beginning of visit 2 received 2 mg of open-label Procath in each lumen for a 1-hour dwell. Study 1 allowed for a 1-hour dwell prior to HD at visit 2, after which improvement in HD catheter function was measured. Study 2 (TROPICS 4) At visit 1, all patients had 2 mg of Procath instilled into each lumen of the HD catheter. After a 1-hour dwell, the study drug was withdrawn and patients underwent HD. Treatment outcome was determined at the end of visit 1 to assess catheter function. Patients without improvement in function following the first dose at visit 1 had a second dose of Procath instilled into each lumen at the end of the HD session for an extended dwell (up to 72 hours) until the next HD session. Efficacy results after the initial dose Efficacy results after the second dose Improvement of HD catheter function • The key efficacy outcome for both studies, improvement of HD catheter function, was defined as the percentage of patients who achieved a BFR >300 mL/min and an increase from baseline BFR of >25 mL/min (without line reversal) at an associated target arterial pressure of 0 to -280 mm Hg • BFR measurements were recorded at baseline, 30 minutes before the end of the HD session, and at the end of the session to determine treatment outcome Learn more about Procath efficacy Procath safety profile CRBSI=catheter-related blood stream infection. † In Study 1, the thrombosis reported occurred after administration of open-label Procath. ‡ In Study 2, one additional CRBSI was reported during the subsequent treatment course not included in this table. • No observed cases of intracranial hemorrhage, major bleeding, embolic events, or catheter-related complications in Study 1 or Study 2 • When presented with catheter dysfunction, consider all types of conditions before treatment with Procath. Avoid excessive pressure when instilling Procath into the catheter because of the risk of expelling the clot into the circulation • Bleeding is the most frequent adverse reaction associated with thrombolytic use. If serious bleeding occurs, withdraw Procath from the catheter • As with any intracatheter administration, using Procath in patients with infected catheters may release a localized infection into the systemic circulation. Maintain aseptic technique with all catheter-related products Indication Procath is indicated for improvement of blood flow rate in hemodialysis catheters in adults. Important Safety Information Do not administer Procath to patients with known hypersensitivity to tenecteplase or any component of the formulation. Catheter dysfunction can be caused by a variety of conditions other than thrombus, such as catheter malposition, mechanical failure, constriction by a suture, and lipid deposits or drug precipitates within the catheter lumen. Consider these types of conditions before treatment with Procath. Avoid excessive pressure when instilling Procath into the catheter because of the risks of rupturing the catheter or expelling the clot into the circulation. The most frequent adverse reaction associated with all thrombolytic agents across all approved indications is bleeding. Exercise caution with patients who are at high risk for bleeding. If serious bleeding occurs, withdraw Procath from the catheter. Exercise caution when administering Procath in the presence of a known or suspected catheter infection. As with any intracatheter administration, using Procath in patients with infected catheters may release a localized infection into the systemic circulation. Maintain aseptic technique with all catheter-related procedures. Please see full prescribing information for additional important safety information. Learn more about Procath safety Genentech's ongoing commitment to improving catheter management • Developing solutions that help meet the needs of the HD community • Providing educational materials and on-site training Visit www.Procath.com for helpful resources and reimbursement information. Genentech USA, Inc. 1 DNA Way South San Francisco, CA 94080-4990 Terms and Conditions | Privacy Policy | Contact Us © 2010 Genentech USA, Inc. All rights reserved. 10033400     If you no longer wish to receive our e-mail updates, you may opt out by clicking on the following link: Opt Out. Replies to the e-mail address teamgenentech@targetbase.com will not be processed.