Single-Use Vial Lytic Thrombolytic - Cathflo® Activase® (alteplase)

Time 2020-09-14 22:05:45

Web Name: Single-Use Vial Lytic Thrombolytic - Cathflo® Activase® (alteplase)

WebSite: http://www.cathflo.com

ID:46737

Keywords:

Vial,Lytic,Single,

Description:

Cathflo® Activase® (alteplase) — The only thrombolytic agent FDA-approved for adult and pediatric patients and the standard of care for treatment of thrombotically occluded catheters as assessed by the ability to withdraw blood 1,3,23 View videos and instructions for the recommended dosing and administration of Cathflo Get useful tools to help you ensure and promote patency in your clinical practice Your Genentech Clinical Specialist is available to contact you about your Cathflo information request Cathflo® Activase® (alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. ContraindicationsCathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation. GeneralCertain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (e.g. catheter malposition, mechanical failure, constriction by a suture and lipid deposits or drug precipitates within the catheter lumen).These types of conditions should be considered before treatment with Cathflo Activase.Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter.Such force could cause rupture of the catheter or expulsion of the clot into the circulation. BleedingThe most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Cathflo Activase has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics. Caution should be exercised with patients who have any condition for which bleeding constitutes a significant hazard.Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment with Cathflo Activase should be stopped and the drug should be withdrawn from the catheter. InfectionsCathflo Activase should be used with caution in the presence of known or suspected infection in the catheter. Using Cathflo Activase in patients with infected catheters may release a localized infection into the systemic circulation. As with all catheterization procedures, care should be used to maintain aseptic technique. HypersensitivityHypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase. Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary. Drug Interactions and Drug/Laboratory Test InteractionsThe interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied.Potential interactions between Cathflo Activase and laboratory tests have not been studied. Carcinogenesis, Mutagenesis, Impairment of FertilityLong-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility. PregnancyThere are no adequate and well-controlled studies in pregnant women. Cathflo Activase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Adverse ReactionsIn clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. Please see accompanying full Prescribing Informationfor additional important safety information. Infusion Nurses Society. Infusion therapy standards of practice. J Infus Nurs. 2016;39(suppl 1):S1-S159. Blaney M, Shen V, Kerner JA, et al; for CAPS Investigators. Alteplase for the treatment of central venous catheter occlusion in children: results of a prospective, open-label, single-arm study (the Cathflo Activase Pediatric Study). J Vasc Interv Radiol. 2006;17(11, pt 1):1745-1751. Camp-Sorrell D, ed. Access Device Standards of Practice for Oncology Nursing. 4th ed. Pittsburgh, PA: Oncology Nursing Society; 2017:1-85. McKnight S. Nurse's guide to understanding and treating thrombotic occlusion of central venous access devices. Medsurg Nurs. 2004;13(6):377-382. Haire WD, Herbst SF. Consensus conference on the use of alteplase (t-PA) for the management of thrombotic catheter dysfunction. J Vasc Access Devices. Summer 2000:1-8. AVA. Study Guide for Vascular Access Certification. Association for Vascular Access;2011:iii-164. Cummings-Winfield C, Mushani-Kanji T. Restoring patency to central venous access devices. Clin J Oncol Nurs. 2008;12(6):925-934. Siegel JD, Rhinehart E, Jackson M, Chiarello L; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. 2007:1-226. Deitcher SR, Fesen MR, Kiproff PM, et al; for the Cardiovascular Thrombolytic to Open Occluded Lines-2 Investigators. Safety and efficacy of alteplase for restoring function in occluded central venous catheters: results of the Cardiovascular Thrombolytic to Open Occluded Lines trial. J Clin Oncol. 2002;20(1):317-324. Doellman D, Buckner JK, Garrett JH Jr, et al. Best practice guidelines in the care and maintenance of pediatric central venous catheters. Herriman, UT: 2015. http://www.avainfo.org/website/article.asp?-id=283140 navitemid=962 -linkid=280826. Accessed March 11, 2016. Frey AM. Intravenous therapy in children. In: Hankins J, Lonsway RAW, Hedrick C, Perdue M, eds. Infusion Therapy in Clinical Practice. 2nd ed. Philadelphia, PA: WB Saunders; 2001:561-591. Richardson D. Vascular access nursing: standards of care, and strategies in the prevention of infection: a primer on central venous catheters (part 2 of a 3-part series). JAVA. 2007;12(1):19-27. Mohiaddin RH, Wann SL, Underwood R, Firmin DN, Rees S, Longmore DB. Vena caval flow: assessment with cine MR velocity mapping. Radiology. 1990;177(2):537-541. Raaf JH. Results from use of 826 vascular access devices in cancer patients. Cancer. 1985;55(6):1312-1322. Stephens LC, Haire WD, Kotulak GD. Are clinical signs accurate indicators of the cause of central venous catheter occlusion? J Parenter Enteral Nutr. 1995;19(1):75-79. National Institutes of Health. Management of central venous catheter occlusions. Pharm Update. 1999: 1-4. Ryder M. The role of biofilm in vascular catheter-related infections. N Dev Vasc Dis. 2001;2:15-25. Hadaway LC. Reopen the pipeline for IV therapy. Nursing. 2005;35(8):54-61. Wingerter L. Vascular access device thrombosis. Clin J Oncol Nurs. 2003;7(3):345-348. Kaler W, Chinn R. Successful disinfection of needleless access ports: a matter of time and friction. JAVA. 2007;12(3):140-142. Ponec D, Irwin D, Haire WD, et al; Recombinant tissue plasminogen activator (alteplase) for restoration of flow in occluded central venous access devices: A double-blind placebo-controlled trial—the cardiovascular thrombolytic to open occluded lines (COOL) efficacy trial. JVIR. 2001;12:915-955. The information contained in this section of the site is intended for U.S. healthcare professionals only. Click OK if you are a healthcare professional. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. 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